Nurses in Diabetes

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Cochrane Database of Systematic Reviews
Specialist nurses in diabetes mellitus (Review)
Loveman E, Royle P, Waugh N
Loveman E, Royle P, Waugh N.

Specialist nurses in diabetes mellitus.
Cochrane Database of Systematic Reviews 2003, Issue 2. Art. No.: CD003286.
DOI: 10.1002/14651858.CD003286.
www.cochranelibrary.com
Specialist nurses in diabetes mellitus (Review)

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews
TABLE OF CONTENTS
HEADER......................................................................................................................................................................................................... 1
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
BACKGROUND.............................................................................................................................................................................................. 3
OBJECTIVES.................................................................................................................................................................................................. 4
METHODS..................................................................................................................................................................................................... 4
RESULTS........................................................................................................................................................................................................ 6
DISCUSSION.................................................................................................................................................................................................. 8
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 8
ACKNOWLEDGEMENTS................................................................................................................................................................................ 9
REFERENCES................................................................................................................................................................................................ 10
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 13
DATA AND ANALYSES.................................................................................................................................................................................... 22
Analysis 1.1. Comparison 1 Results, Outcome 1 Results.................................................................................................................... 22
APPENDICES................................................................................................................................................................................................. 22
WHAT'S NEW................................................................................................................................................................................................. 23
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 23
DECLARATIONS OF INTEREST..................................................................................................................................................................... 23
SOURCES OF SUPPORT............................................................................................................................................................................... 23
INDEX TERMS............................................................................................................................................................................................... 23
Specialist nurses in diabetes mellitus (Review) i

Informed decisions.
[Intervention Review]
Specialist nurses in diabetes mellitus
Emma Loveman1, Pamela Royle2, Norman Waugh3
1Southampton Health Technology Assessments Centre, University of Southampton, Southampton, UK. 2Department of Public Health,
University of Aberdeen, School of Medicine, Aberdeen, UK. 3Department of Public Health, University of Aberdeen, Aberdeen, UK
Contact address: Hubertus JM Vrijhoef, Health Care Studies, University Maastricht, Universiteitssingel 40, Maastricht, 6200 MD,
Netherlands. [email protected].
Editorial group: Cochrane Metabolic and Endocrine Disorders Group.

Publication status and date: Edited (no change to conclusions), published in Issue 1, 2010.
Citation: Loveman E, Royle P, Waugh N. Specialist nurses in diabetes mellitus. Cochrane Database of Systematic Reviews 2003, Issue 2.
Art. No.: CD003286. DOI: 10.1002/14651858.CD003286.
ABSTRACT
Background
The patient with diabetes has many different learning needs relating to diet, monitoring, and treatments. In many health care systems
specialist nurses provide much of these needs, usually aiming to empower patients to self-manage their diabetes. The present review aims
to assess the effects of the involvement of specialist nurse care on outcomes for people with diabetes, compared to usual care in hospital
clinics or primary care with no input from specialist nurses.
Objectives
To assess the effects of diabetes specialist nurses / nurse case manager in diabetes on the metabolic control of patients with type 1 and
type 2 diabetes mellitus.
Search methods
We carried out a comprehensive search of databases including the Cochrane Library, MEDLINE and EMBASE to identify trials. Bibliographies
of relevant papers were searched, and hand searching of relevant publications was undertaken to identify additional trials.
Selection criteria
Randomised controlled trials and controlled clinical trials of the effects of a specialist nurse practitioner on short and long term diabetic
outcomes were included in the review.
Data collection and analysis

Three investigators performed data extraction and quality scoring independently; any discrepancies were resolved by consensus.
Main results
Six trials including 1382 participants followed for six to 12 months were included. Two trials were in adolescents. Due to substantial
heterogeneity between trials a meta-analysis was not performed. Glycated haemoglobin (HbA1c) in the intervention groups was not
found to be significantly different from the control groups over a 12 month follow up period. One study demonstrated a significant
reduction in HbA1c in the presence of the diabetes specialist nurse/nurse case manager at 6 months. Significant differences in episodes
of hypoglycaemia and hyperglycaemia between intervention and control groups were found in one trial. Where reported, emergency
admissions and quality of life were not found to be significantly different between groups. No information was found regarding BMI,
mortality, long term diabetic complications, adverse effects, or costs.
Specialist nurses in diabetes mellitus (Review) 1

Informed decisions.
Authors' conclusions
The presence of a diabetes specialist nurse / nurse case manager may improve patients' diabetic control over short time periods, but
from currently available trials the effects over longer periods of time are not evident. There were no significant differences overall in
hypoglycaemic episodes, hyperglycaemic incidents, or hospital admissions. Quality of life was not shown to be affected by input from a
diabetes specialist nurse/nurse case manager.
PLAIN LANGUAGE SUMMARY
Specialist nurses in diabetes mellitus
Specialist diabetes nurses provide education and support services to people with diabetes in many health care systems. A key goal is
helping enable people to self-manage their diabetes. However, this review of trials found no strong evidence of benefit of care from
specialist diabetes nurses for adolescents and adults with diabetes. Although short-term benefits may be possible, this has not been shown
to result in long-term improvements. People receiving care from diabetes nurses do not appear to have improved health when compared
with usual care in hospital clinics or primary care with no specialist nursing input. No data were shown on quality of life measures.

Informed decisions.
BACKGROUND Education
Education is probably the most important role of the specialist
Education of the patient with diabetes
nurse, with a large amount of information regarding the disease,
Treatment goals of diabetes are avoidance of late diabetic its control and life style changes, needing to be imparted over a
complications, normalisation of blood glucose levels and to enable prolonged period of time. Increasing the patient's understanding
people with diabetes to achieve a good health related quality of the disease through education can prevent or delay the onset
of life. The patient with diabetes has to cope with many issues of complications and reduce the number of hospitalisations, and
regarding the chronic disease, its control and complications. as such is the key to improving the quality of life (Diab education
Education is not only required in the first few months following 1985).
diagnosis, but is also a necessary component of their care
throughout, and should be adjusted to the patient's own individual Counselling
needs. Therefore, behavioural modifications require long-term Alongside the role of educator, the specialist nurse also provides a
information, education and care. counselling role (Brown 1988). In addition to learning new practical
skills, the patients have to take on the implications of a life-long
The diabetes specialist nurse / nurse case manager disease, and may need help in accepting the changes which are
Specialist nurses are defined as 'a registered nurse, who, after a occurring in their lives. The specialist nurse is in a unique position
significant period of experience in a specialised field of nursing and in that a relationship between patient and nurse will be maintained
with additional nursing education, is authorised to practice as a over a long period of time, and can provide support and time for
specialist with advanced expertise in a clinical specialty to involve patients as part of their role.
in clinical practice, consultation, teaching and research' (Tang
1993). Specialist nurses may or may not have a formal qualification Disease management
in diabetes care. In addition, the specialist diabetes nurse will also The specialist nurse may also make adjustments to a patient's
be defined as a nurse who works wholly in diabetes care, based in treatment regimen, for example insulin dosage. Nurses may also
either the hospital or community, including domiciliary visits, and advise patients on the management of intercurrent illnesses, in
crossing the boundaries between the two. particular advising on diabetic treatments during other illnesses.
This enables a broader approach to patient management.
Nurse case managers will be defined as registered nurses who are
certified diabetes educators and trained to follow a set of detailed The non-educational roles of the diabetes specialist nurse may
management algorithms specific to diabetes (Aubert 1998). increase the effectiveness of education.
In many areas of Europe, Australia, New Zealand, and the USA, Diabetes information given to patients at any time needs to be
specialist nurses provide much of the education and support up-to-date and consistent to reduce possible confusion caused
given to patients with diabetes in both community and acute by conflicting advice. Throughout the course of the disease
hospital settings. However, variations in health care, both within patients are likely to come into contact with a number of health
and between countries (Felton 1997) mean that whilst some professionals, such as dieticians, primary care physicians, nurses,
patients gain access to the specialist nurses, others do not. This chiropodists, and the specialist nurse has a role in maintaining the
variation largely depends upon the accessibility of funds and the professional knowledge of these people. Similarly the specialist
preference of individual clinicians. The present review aims to nurse has a responsibility to ensure that the position of other health
assess the effects of specialist nurse care; which includes education care professionals are not undermined by the advent of specialist
of people with diabetes, the provision of ongoing advice on nurses. Other roles of the specialist nurse are in research, and
controlling diabetes, advice on dealing with intercurrent illnesses, advising on local policies (Grzebalski 1997).
advice/supervision of initiation of treatment(s), and advice about
learning to live with the diagnosis of diabetes, in comparison to The role of the nurse case manager
no intervention from a specialist nurse. The review recognises that
nurses act within complex health care systems and are often part In the USA, diabetes self management education is performed by
of a broader package of care. The review attempts to identify other a range of health care professionals such as nurses, dieticians,
possible influencing variables within each included trial, and in pharmacists, exercise specialists, doctors and social workers who
addition included studies in which the service of a specialist nurse have become 'Certified Diabetes Educators', (Felton 1997). Their
is added to an existing diabetes service which otherwise did not role in the care of patients with diabetes will reflect only some
change. Only nurse interventions at individual patient level were of those of the specialist nurse. In particular, they are much less
included. Education in groups were excluded. likely to make adjustments to treatments regimens, or advise
on intercurrent illnesses. Similarly, education of other health
The role of the diabetes specialist nurse care professionals, and coordination of the patients care are not
undertaken by the diabetes educator (AADE 2001). However, some
Diabetes is a complex condition, and has effects on many aspects nurse diabetes educators, have also been trained to be nurse case
of peoples lives. The specialist nurse is typically involved in co- managers. Their role is similar to that of the specialist nurse, for
ordinating the ongoing care of patients, educating and counselling, example they can make adjustments to treatments following a set
but also providing advice on medication and management of of management algorithms (Aubert 1998). Therefore, nurse case
intercurrent illness. managers are included in this review.

Informed decisions.
Integration into health care systems METHODS

In the UK, the British Diabetic Association report of 1985 Criteria for considering studies for this review
recommended that each health district, serving 200,000 people,
should have a minimum of two diabetes specialist nurses. This Types of studies
was increased to four per 250,000 people in 1991. Current practice
Studies were considered eligible if they were randomised
levels have not always met this recommendation and an Audit
controlled trials or controlled clinical trials fulfilling the inclusion
Commission Study showed that only two of nine study sites
criteria. The minimum trial duration was for a period of six months.
audited met these recommended standards (Audit Comm. 2000).
This was based on experience with evidence of trials of other
Recommendations from the Royal College of Nurses in the UK are
behavioural interventions.
that specialists nurses are paid at least at a level of a ward sister
(RCN 1991), with many in more senior positions. Costs of these Types of participants
posts are potentially offset by savings made from reduced inpatient
treatments for acute complications of diabetes, such as hypo- or Children and adults with type 1 or type 2 diabetes were included.
hyperglycaemia, and treatment of chronic complications such as
Diagnostic criteria
diabetic foot ulcers. Savings may also be made from increasing
compliance in patients. To be consistent with changes in classification and diagnostic
criteria of diabetes through the years, the diagnosis was established
Effectiveness of specialist nurses using the standard criteria valid at the time of the beginning of the
Evidence of the effectiveness of diabetes specialist nurses is at trial.
present unclear. Patients in contact with specialist nurses are Types of interventions
generally satisfied with the level of care that they receive (Gafvels
1996) and it is thought that patients often contact the specialist • Specialist nurse intervention in addition to routine care versus
nurses in preference to their general practices. The impression routine care at individual patient level.
is that this is because the specialist nurses can provide better • Paediatric specialist nurse intervention versus routine care at
information and advice than general practice staff. However, individual patient level in the management of children with
measurement of outcomes of receiving care from a specialist nurse diabetes.
has not been reviewed in a systematic way. Thus a review of the
evidence of the benefits and effectiveness of the nurse specialist is Types of outcome measures
required.
Primary outcomes
The primary purpose of this review was to assess the evidence Outcome measures reflected the different stages of the disease in
base for specialist nurses in general. However, in recent years which the specialist nurse was involved:
there has been some sub-specialisation, particularly in the UK,
with separation of nursing care for children and adults. This is not • glycosylated haemoglobin (HbA1c);
universally accepted, and a secondary aim was to see if there is • sort term diabetic complications (hypoglycaemic episodes,
any evidence to support the splitting of specialist nursing care into ketoacidotic incidents);
adult and paediatric groups. • long term diabetic complications (e.g. diabetic retinopathy,
neuropathy, nephropathy).
Description of the condition
Diabetes mellitus is a metabolic disorder resulting from a defect Secondary outcomes
in insulin secretion, insulin action, or both. Insulin deficiency leads • mortality;
to chronic hyperglycaemia (i.e. elevated levels of plasma glucose) • emergency admissions;
with disturbances of carbohydrate, fat and protein metabolism.
Long-term complications include retinopathy, nephropathy and • quality of life, ideally using a validated instrument;
neuropathy. The risk of cardiovascular disease is increased. There • body mass index (BMI);
are various types of diabetes mellitus of differing etiology. The • costs:
most common types are type 1 and type 2 diabetes. For a • adverse effects.
detailed overview of diabetes mellitus please see under 'Additional
information' in the information on the Metabolic and Endocrine Timing of outcome measurements
Disorders Group in The Cochrane Library (see 'About', 'Cochrane Medium (6-12 months) and long term (more than 12 months)
Review Groups (SRGs)'). For an explanation of methodological outcome measurements were assessed.
terms, see the main glossary in The Cochrane Library.
Search methods for identification of studies
OBJECTIVES
Electronic searches
To assess the effects of diabetes specialist nurses/nurse case
managers on diabetes in patients with diabetes mellitus. We used the following sources for the identification of trials:
• The Cochrane Library (1981-2002);

• MEDLINE (1966-2002);
• EMBASE (1981-2002);

Informed decisions.
• CINAHL 1982-2002; Data extraction and management

• British Nursing Index 1994-2002; All three reviewers were involved in the data extraction process.
• Royal College of Nursing Journals Database 1985-1996; Data concerning details of the study population, the intervention
• Health STAR 1981-2000/12; and outcomes were extracted independently by two of the three
• BIOSIS 1985-2002; reviewers in each case using a data extraction form. This included
• PsycINFO 1977-2002; the following information:
(1) general information: title, authors, source, contact address,
• Science Citation Index 1981-2002; country, region (urban/rural), setting (hospital or community),
• Social Sciences Citation Index 1981-2002. language of publication, sponsoring, published/unpublished;
(2) trial characteristics: design, randomisation (and method),
We also searched databases of ongoing trials: Current Controlled
allocation concealment, duration;
Trials (www.controlled-trials.com - with links to other databases of
(3) intervention(s): intervention, comparison intervention,
ongoing trials).
(including length and nature of intervention), concurrent
The described search strategy (see under Appendix 1) was used for treatments;
MEDLINE. For use with EMBASE, The Cochrane Library and the other (4) participants: sampling, exclusion criteria, numbers, gender,
databases this strategy was slightly adapted. age, baseline characteristics (for example glycated haemoglobin,
BMI, ethnicity, sociodemographic details), duration of diabetes,
Handsearching intervention and control comparable at baseline, drop outs,
withdrawals and losses to follow up, subgroups;
The journals Diabetic Medicine, Diabetes Care, Diabetologia, and (5) outcomes: as specified above, how outcomes were assessed,
Diabetes were hand searched for articles and proceedings of length of follow up, quality of reporting of outcomes;
conferences abstracted in these journals from 1990 to 2001. (6) results: for the outcomes as specified, intention-to-treat
Conference abstracts searched were: Abstracts of the Annual analysis.
meetings of the European Association for the Study of Diabetes
(EASD), and the Annual professional meetings of the British Where necessary, authors were contacted about missing
Diabetic Association. information in their trials.
We also searched reference lists of relevant trials and reviews. Differences in data extraction were resolved by consensus.
Grey literature Amendments to protocol
Web of Science Proceedings 1990-2002, Conference Papers Index Two amendments have been made to the published research
1982-2002, HMIC (Health Management Information Consortium) protocol: trials with a six month period of follow up were included
databases, UK Theses, SIGLE. and the quality assessment of controlled clinical trials followed the
CRD criteria.
It was anticipated that additional key words of relevance might
have been identified during any of the electronic or other searches, Assessment of risk of bias in included studies
and if this was the case, that the electronic search strategies would
be modified to incorporate these terms. There were however, no Assessment of the quality of reporting of each trial was based
additional key words added to the search strategy. largely on the quality criteria specified by Schulz and Jadad (Jadad
1996; Schulz 1995a; Schulz 1995b).
Data collection and analysis In particular the following factors were studied:
(1) Minimisation of selection bias - a) was the randomisation
Selection of studies procedure adequate? b) was the allocation concealment
Two independent observers (EL, PR) reviewed titles, abstracts and adequate?
keywords of all records retrieved. Full articles were retrieved for (2) Minimisation of attrition bias - a) were withdrawals properly
further assessment if the information given suggested that the described? b) was analysis by intention to treat?
study: 1. included patients with type 1 or type 2 diabetes mellitus, (3) Minimisation of detection bias - were outcome assessors blind
2. compared specialist nurse intervention with no specialist nurse to the intervention?
intervention, or paediatric nurse intervention to standard specialist
Based on these criteria, studies were broadly subdivided into the
nurse intervention, in which it was required that the intervention
following three categories (see Cochrane Handbook):
was evaluating the nurse alone (i.e. not a team approach),
A: All quality criteria met: low risk of bias.
where education was individually based, and where nurses had
B: One or more of the quality criteria only partly met: moderate risk
responsibility for adjusting treatment regimens, 3. assessed one
of bias.
or more of the defined outcome measures. Full articles were also
C: One or more criteria not met: high risk of bias.
retrieved for clarification, when there was doubt about eligibility.
Interrater agreement was assessed using Cohen's Kappa (Fleiss Each trial was assessed independently by two assessors (EL, NW).
1981). In cases of disagreement a judgement was made based upon Interrater agreement was assessed using Cohen's Kappa (Fleiss
discussion with a third independent reviewer (NW). 1981). In cases of disagreement an assessment was made by a third
independent assessor (PR) and then judgement was made based
on consensus referring back to the original article.

Informed decisions.
As the number of trials identified was low, we included controlled ranged from between 45 and 61 years. Participants of one trial were
clinical (non randomised) trials, and used the following quality members of American Indian and Alaskan Native ethnic groups
criteria (CRD): Were the groups similar at baseline in terms of (Wilson 2001). The type of diabetes was noted in only one of the
prognostic factors? Were the eligibility criteria specified? Were adult trials and was reported to be type 1 diabetes in approximately
outcome assessors blinded to the treatment allocation? Were half of this population. Duration of diabetes was reported in only
the point estimates and measure of variability presented for the three trials, with the range of mean duration of diabetes in the
primary outcome measure? Did the analyses include an intention adolescent trials being 4 - 8 years and in the adult trial from
to treat analysis? Were withdrawals and dropouts completely 14-19 years (Thompson 1999). Criteria for entry into the individual
described? Were participants likely to be representative of the studies are outlined in the table Characteristics of included studies
intended population? (characteristics of included studies).
RESULTS Interventions
In only three trials (Couper 1999; Marrero 1995; Thompson 1999)
Description of studies
was the diabetes specialist nurse / nurse case manager directly
Results of the search responsible for the alteration of treatment regimens, in others the
nurse made a recommendation for treatment change. Whilst it
6400 citations with their abstracts were obtained from electronic
cannot be clearly determined whether the physician has acted on
searches up to 2000, of which 53 were deemed relevant. No
these recommendations; this is often likely to be the case. For this
trials were identified from hand searching. A subsequent search in
reason these studies were included in the review.
November 2001 identified 572 further citations, of which nine were
deemed relevant. An updated search in February 2002 identified no In the two adolescent trials, a nurse case management approach
further relevant trials. A further updated search in November 2002 was used, and in both cases some use was made of electronic
identified 1 trial that was deemed relevant. In total 63 trials were communication such as telephone contact. In one of these
deemed relevant from the abstracts for eligibility. Full papers were trials nurses, together with the patients, set individual goals for
retrieved for all of these trials and independently assessed by two frequency of blood glucose monitoring and insulin adjustment
reviewers for inclusion. according to target blood glucose levels (Couper 1999). These
participants also received weekly phone calls from the nurse. In
Missing data
the Marrero 1995 trial the adolescents used a glucometer with
We contacted Drs Aubert, Davis and Wilson to clarify details of their a modem which transmitted data from self monitoring of blood
trials. Dr Wilson supplied further information. glucose to the hospital every two weeks. The nurse practitioners
then suggested follow up care by telephone using an algorithm for
Assessment of publication bias inter-rater agreement regimen adjustments, referrals and advice.
In general, agreement was high between the two reviewers, (kappa In two of the adult trials a nurse case management approach
= 0.84). Some cases were unclear and in these cases a third was combined with automated telephone calls in which structured
independent assessment was made and agreement was reached messages were relayed to patients, and where patients could
following discussion. report blood glucose levels, symptoms and self-care (Piette 2000a;
Included studies Piette 2001). Telephone contact with the nurse was made following
reports generated by the automated telephone calls, and nurses
Five trials initially met the inclusion criteria. Authors of additional also made periodic calls. Patients in the intervention groups could
three trials (Aubert 1998; Davies 2000;Wilson 2001) were contacted also receive automated self-care calls. Nurses in these studies
for further information to assess eligibility, only one reply (Wilson were unable to suggest alterations to treatments directly, rather
2001) was received. This trial was presented as an abstract only and recommended dosage adjustments to the primary care physician.
included on the basis of the information supplied from the author.
In the Thompson 1999 trial, the nurses also made use of telephone
Study design communication; patients were given individualised telephone
contacts in which adjustments to treatments were recommended.
Included studies were randomised controlled trials in all cases with
The Wilson 2001 trial supplemented diabetes care with a nurse
the exception of Couper 1999 which was a controlled clinical trial,
care coordinator who provided direct alterations in the patients
where a geographical region was divided into two. The duration of
care, and suggested alterations in medication to the primary care
included trials was 12 months in four trials (Marrero 1995; Piette
physician. In all trials the control interventions was 'usual care'
2000a; Piette 2001; Wilson 2001), 18 months in the Couper 1999 trial
which included contact with the physician and other members of
and six months in the Thompson 1999 trial.
the multidisciplinary team as necessary.
Participants
Duration of the intervention
A total of 1382 participants were included in the six trials. The
With the exception of the study by Couper 1999 no trial reported
individual study sample size ranged from 73 to 585. Participants
the duration of the intervention and it is not clear whether the
gender was approximately distributed equally, except in the Piette
intervention continued for the same length of time as the length of
2001 study which was of a group of veterans, the majority of whom
follow up.
were male. Gender was not reported in one trial (Wilson 2001). Two
trials (Marrero 1995; Couper 1999) were in adolescents, with mean
ages of 13 and 14 years respectively. Mean ages in the adult trials

Informed decisions.
Outcomes Effects of interventions

All included trials used glycated haemoglobin as an endpoint. Glykosylated haemoglobin A1c (HbA1c) - randomised
Three trials also reported sub-group analyses of HbA1c. These controlled clinical trial in adults
were: those with a pre-defined normal HbA1c of less than 6.4%
in the Piette 2000a trial, those with greater than 8% HbA1c Adjusting for differences in baseline insulin use, Piette 2000a found
and greater than 9% HbA1c in the Piette 2001 trial, and the no significant difference in HbA1c between groups at 12 months
proportion of participants with at least a 10% drop in HbA1c in the (intervention 8.1%, control 8.4% [95% CI = -0.7 to 0.1%] P = 0.1).
Thompson 1999 trial. Other primary outcomes included number of The intervention group had similar mean HbA1c levels to the
hypoglycaemic episodes, hyperglycaemic incidents (Piette 2000a; control group at 12 months in the Piette 2001 trial (intervention
Piette 2001), emergency room visits and hospitalisations (Marrero 8.1% [SD 0.1], control 8.2% [SD 0.1], P<0.3). In these two (Piette
1995; Piette 2000a). Quality of life was used as an outcome in one 2000a; Piette 2001) studies, the nurse was not solely responsible
trial, unfortunately no data were presented (Marrero 1995). for adjustments to treatments. In the Thompson 1999 trial, a
significant reduction in HbA1c was seen between the two groups
Excluded studies at six months (Intervention 7.8% [SD 0.8], control 8.9% [SD 1.0],
p<0.01). At baseline the intervention group and control group were
Evaluation of the full papers of the 63 trials identified, led to not reported to be statistically different in any of these trials.
exclusion of 55 trials. 2 further trials were excluded as no further
information was received after contacting the relevant authors. Results from Wilson 2001 study (with up to 35% participants data
Reasons for exclusions included not having any of the reviews missing) demonstrated a mean HbA1c of 8.8% [SD 2.1] in the
prespecified outcomes, a too short period of follow-up, no control intervention group versus 8.6% [SD 2.4] in the control group at
group, other members of team involved in patient care, education baseline. Data at 12 month follow-up showed a mean HbA1c of
in groups, or nurses were unable to adjust treatments. In many 8.9% [SD 2.1] in the intervention versus 8.7% [SD 2.2] in the control
cases more than one of the mentioned reasons were present. group. These differences were not statistically significant.
Reasons for excluding trials can be seen in the table Characteristics
of excluded studies. HbA1c - randomised controlled clinical trial in adolescents
No significant differences in HbA1c were demonstrated in the
Risk of bias in included studies
Marrero 1995 trial between the two groups (intervention 9.6%
The five randomised controlled trials could be classified by their [SD1.9], control 9.7% [SD 1.5]) at six months. A similar finding was
quality into three studies with moderate risk of bias (Piette 2000a; noted at 12 months (intervention 10.0% [SD1.6], control 10.3%
Piette 2001; Thompson 1999) and two studies with high risk of [SD1.8]).
bias (Marrero 1995; Wilson 2001). The controlled clinical trial
was classified as having one or more quality criteria not met. HbA1c - controlled clinical trial in adolescents
Interrater agreement of trial quality was 0.33. Agreement was In the Couper 1999 trial there were no statistically significant
reached following discussion with a third reviewer. differences between the intervention and control groups at 6, 12 or
18 months (intervention 9.7% [SD 1.6], control 10.3% [SD 2.2] at six
Minimisation of selection bias
months, intervention 10.5% [SD 1.8], control 10.7% [SD 2.0] at 12
Of the five RCT's, the randomisation method was described and months, intervention 10.0% [SD 1.5], control 10.5% [SD 1.8] at 18
deemed to be adequate in three trials (Piette 2000a; Piette 2001; months).
Thompson 1999). Of the remaining trials; a lottery was used in the
Wilson 2001 study, however, no further details of this are available, Subgroup analyses
and the Marrero 1995 trial does not report details of the method of In a subgroup of patients who had HbA1c greater or equal to 8.0%
randomisation. Evidence of adequate allocation concealment was at baseline in the Piette 2001 study the intervention group had
noted in two trials only (Piette 2001; Thompson 1999). No report significantly lower HbA1c than controls at 12 months (8.7 ± 0.2%
of allocation concealment was made in the Wilson 2001 trial or versus 9.2 ± 0.2%, p=0.04). Similarly, in patients who had HbA1c
the Marrero 1995 trial, and it is unclear whether allocation was greater or equal to 9.0% at baseline the intervention group had
concealed in the Piette 2000a study. significantly lower HbA1c than controls at 12 months (9.1± 0.3%
versus 10.2 ± 0.3% p=0.04).
Minimisation of attrition bias
Numbers of study withdrawals were described in the four trials that Thompson 1999 observed the proportion of patients with greater
had losses to follow up (Couper 1999; Piette 2000a; Piette 2001; or equal to 10% reduction in HbA1c at six months; the proportion of
Wilson 2001). Analysis was reported to be by intention to treat in patients in the intervention group was statistically higher than the
both Piette 2000a and Piette 2001. No intention to treat analysis was proportion in the control group (intervention 87% versus control
undertaken in the Wilson 2001 or Couper 1999 trials. No losses to 35%, p<0.001).
follow up were reported by Marrero 1995 or Thompson 1999.
In the Piette 2000a trial the proportion of patients defined as having
Minimisation of detection bias a normal HbA1c level of less than 6.4% was significantly greater
in the intervention group at 12 months than the control group
All trials evaluated diabetic control using HbA1c. Details of blinding (intervention 17% versus control 8%, p=0.04).
of outcome assessors were not described in any of the trials.

Informed decisions.
Hypoglycaemic episodes DISCUSSION

In adjusted outcomes for baseline differences in insulin use,
Summary
hypoglycaemic episodes experienced throughout the intervention
period of the Piette 2000a study were reported to be significantly This systematic review describes five randomised controlled trials
different between the intervention group and control group and one controlled clinical trial studying the effects of a diabetes
(intervention 1.1, control 1.6 [95% CI -0.7 to -0.2] p=0.001). In the specialist nurse or nurse case manager on people with diabetes.
Piette 2001 trial hypoglycaemic symptoms were not statistically All of the trials examined glycated haemoglobin, a measure of long
different between the intervention and control group. No units term blood glucose control, as an endpoint. Despite there being
of measurement used for these episodes in the two trials were an improvement in glycaemic control in the intervention groups of
provided. many of the trials reviewed, HbA1c in the intervention groups was
not found to be significantly different from the control groups over
Hyperglycaemic incidents a 12 month follow up period. One study demonstrated a reduction
Hyperglycaemic incidents were reported in two trials (Piette 2000a; in HbA1c in the intervention group when compared to the control
Piette 2001). Piette 2000a reported a significantly lower number group at six month. In sub-groups of patients with higher baseline
of events in the intervention group than the control group for the levels of HbA1c, a significant difference was observed between the
period of the trial (intervention 1.6, control 2.3 [95% CI -1.9 to intervention and control groups at 12 months, with the intervention
-0.4] p=0.0005). Hyperglycaemic symptoms were not significantly groups having better metabolic control. Similarly, the proportion of
different between the intervention and the control group in the participants with a greater than 10% drop in HbA1c was statistically
Piette 2001 trial. No units of measurement used for htese incidents significantly different between groups. Other outcomes such as
in the two trials were provided. hypoglycaemic or hyperglycaemic episodes were not found to be
different as a result of the intervention and were generally poorly
Emergency room visits reported.
The Marrero trial reported no significant differences between From currently available trials the effects of a diabetes specialist
emergency room visits in the intervention or control groups of nurse / nurse case manager does not appear to be strong over
their study of adolescents. Piette 2000a reported an increase in longer periods of time. Unfortunately, it is difficult to establish from
emergency room visits amongst the intervention group throughout the reporting in many of the trials how long the interventions were
the period of the study which was not statistically significant. undertaken for. In general the quality of the trials included in this
review was not good. Only two of the included trials described their
Hospitalisations method of allocation concealment, and despite the proportion of
There were no statistical differences in hospital admissions drop outs ranging from 5 to 35% across the trials, only two trials
between the intervention and control group in the Marrero 1995 or carried out an intention to treat analysis.
the Piette 2000a trials.
Methodological considerations and limitations of the
Quality of life review
Marrero 1995 reported no between or within group differences on The diabetes specialist nurse / nurse case manager is an example
measures of quality of life, unfortunately no data were provided. of a complex intervention (MRC 2000) in that their role involves
several components, which makes it difficult to establish with any
Diabetic complications precision which is their active ingredient. This has presented us
No diabetic complications were reported in the included trials. with a number of difficulties in their evaluation. In all included trials
it was important to establish that as far as possible it was only the
Mortality presence of the nurse that was different between the two groups.
Despite this, it is difficult to establish with any degree of certainty
No included study reported mortality as an outcome.
that any effects shown were attributable to that presence alone.
Body mass index (BMI)
The eligibility criteria of the studies were diverse. For example, in
No included study reported BMI as an outcome. the Piette 2001 study all patients were on a hypoglycaemic agent
whereas in the Thompson 1999 study all were on insulin. Similarly,
Costs of the two studies of adolescents, one included only those with
No costs were reported in the included trials. a mean glycated haemoglobin of more than 9% (Couper 1999).
The entry levels of the outcomes were also different in all studies,
Adverse effects with no trials reporting change scores, which leads to difficulties
with standardisation. Pooling of data were therefore deemed to be
No adverse effects were reported in the included trials. inappropriate due to the profound heterogeneity between trials.
Paediatric nurse specialists AUTHORS' CONCLUSIONS
We found no evidence for or against having the care of children
with diabetes provided with nurses who only care for children, Implications for practice
compared to those who look after adults and children. Of the six trials included, the interventions evaluated varied greatly,
as can be seen in Table 1. Some evidence of an effect of the presence
of a specialist nurse was evident at six months, but the findings
Informed decisions.
were greatly reduced beyond this time. This is somewhat similar educational impact of educators alone versus educators (such as
to observations made in reviews of patient education in other the diabetes specialist nurse) who are also involved in clinical
chronic diseases and may be due to few trials assessing outcomes care would be useful, that is do diabetes specialist nurses / nurse
beyond the 6 month period (Cooper 2001). However, in all but case managers have greater educational effect because of their
one trial reported in this review, the follow up period was at least wider role? Thirdly, a randomised controlled trial of specialist nurse
12 months. The quality of the trials was generally low and this intervention should be performed. Because of the rising prevalence
leads to difficulties in assessing the implications for practice. No of diabetes, many health care systems are under considerable
implications for practice can be drawn from available data. financial pressures. Future research should include an economic
component, perhaps in the form of cost per quality adjusted life
Implications for research year.
The present evidence base is unsatisfactory. Future research might
ACKNOWLEDGEMENTS
firstly take the form of an observational study in several countries
to identify the roles and time allocation of diabetes specialist We wish to acknowledge Dr Wilson for supplying further trial
nurses / nurse case managers, since roles vary even within information.
countries. Secondly, qualitative research looking at the relative

Informed decisions.
REFERENCES
References to studies included in this review Blonde 1999 {published data only}
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Sandberg M, et al. Diabetes management by a team of diabetes
Couper JJ, Taylor J. Failure to maintain the benefits of home-
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Marrero 1995 {published data only}
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Marrero DG, Vandagriff JL, Kronz K, Fineberg NS, Golden MP,
Brown SA, Hanis CL. A community-based, culturally sensitive
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Piette 2000a {published data only}
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self-care and glycemic control among vulnerable patients with
diabetes?. American Journal of Medicine 2000;108(1):20-27. Caravalho 2000 {published data only}
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Chan WB, Chan JCN, Chow CC, Yeung VTF, So WY, Li JKY, et
requiring diabetic patients: A randomized trial. Canadian
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Medical Association Journal 1999;161(8):959-62.
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Wilson CA, Bochenski CL. The addition of a nurse care Colagiuri 1995 {published data only}
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Corkery 1997 {published data only}

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Corkery E, Palmer C, Foley ME, Schechter CB, Frisher L,
Ahern 2000 {published data only} Roman SH. Effect of a bicultural community health worker on
Ahern JA, Ramchandani N, Cooper J, Himmel A, Silver D, completion of diabetes education in a Hispanic population.
Tamborlane WV. Using a primary nurse manager to implement Diabetes Care 1997;20(3):254-7.
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Aubert 1998 {published data only} a hospital diabetes specialist nursing service: a randomized
Aubert RE, Herman WH, Waters J, Moore W, Sutton D, controlled trial. Diabetic Medicine 2000;18:301-7.
Peterson BL, et al. Nurse case management to improve
glycemic control in diabetic patients in a health maintenance de Sonnaville 1997 {published data only}
organization. A randomized, controlled trial. Annals of Internal de Sonnaville JJ, Bouma M, Colly LP, Deville W, Wijkel D,
Medicine 1998;129(8):605-12. Heine RJ. Sustained good glycaemic control in NIDDM patients
by implementation of structured care in general practice: 2-year
Barglow 1983 {published data only} follow-up study. Diabetologia 1997;40(11):1334-40.
Barglow P, Edidin DV, Budlongspringer AS, Berndt D, Phillips R,
Dubowe, E. Diabetic control in children and adolescents - Dougherty 1998 {published data only}
psycho-social factors and therapeutic efficacy. Journal of Youth Dougherty GE, Soderstrom L, Schiffrin A. An economic
and Adolescence 1983;12(2):77-94. evaluation of home care for children with newly diagnosed

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diabetes: results from a randomized controlled trial. Medical Heller 1988 {published data only}
Care 1998;36(4):586-98. Heller SR, Clarke P, Daly H, Davis I, McCulloch DK, Allison SP, et
al. Group education for obese patients with type 2 diabetes:
Dougherty 1999 {published data only}
greater success at less cost. Diabetic Medicine 1988;5(6):552-6.
Dougherty G, Schiffrin A, White D, Soderstrom L, Sufrategui M.
Home-based management can achieve intensification cost- Hollander 2001 {published data only}
effectively in type I diabetes. Pediatrics 1999;103(1):122-8. Hollander P, Couch C, Hill S, Sheffield P. An analysis of patient
outcomes between geriatric and non- geriatric type 2 diabetic
Drozda 1993 {published data only}
patients who utilized a diabetes resource nurse case manager
Drozda DJ, Allen SR, Turner AM, Slusher JA, McCain GC. (CDE) in a primary care practice setting. Diabetes 2001;50:A198.
Adherence behaviors in research protocols: comparison of two
interventions. Diabetes Educator 1993;19(5):393-5. Kirkman 1994 {published data only}
Kirkman M, Weinberger M, Simel DL. A telephone-delivered
Estey 1990 {published data only}
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Estey AL, Tan MH, Mann K. Follow-up intervention: its effect on 1994;17(8):840-6.
compliance behavior to a diabetes regimen. Diabetes Educator
1990;16(4):291-5. Koproski 1997 {published data only}
Koproski J, Pretto Z, Poretsky L. Effects of an intervention by a
Everett 1995 {published data only}
diabetes team in hospitalized patients with diabetes. Diabetes
Everett J, Miles P, Jenkins E, Kerr D. Does nurse-led care Care 1997;20(10):1553-5.
help newly diagnosed type 2 patients cope with the crisis of
diagnosis?. Diabet Medicine 1995;12(10):Supplement 2, page S7. Korhonen 1983 {published data only}
Korhonen T, Huttunen JK, Aro A, Hentinen M, Ihalainen O,
Feddersen 1994 {published data only}
Majander H, et al. A controlled trial on the effects of patient
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impact on length of hospital stay. Diabetes Educator Diabetes Care 1983;6(3):256-61.
1994;20(2):125-8.
Korhonen 1987 {published data only}
Fosbury 1997 {published data only}
Korhonen T, Uusitupa M, Aro A, Kumpulainen T, Siitonen O,
Fosbury JA, Bosley CM, Ryle A, Sonksen PH, Judd SL. A trial of Voutilainen E, et al. Efficacy of dietary instructions in
cognitive analytic therapy in poorly controlled type I patients. newly diagnosed non-insulin-dependent diabetic patients.
Diabetes Care 1997;20(6):959-64. Comparison of two different patient education regimens. Acta
Medica Scandinavica 1987;222(4):323-31.
Fukuda 1999 {published data only}
Fukuda H, Muto T, Kawamori R. Evaluation of a diabetes patient Legorreta 1996 {published data only}
education program consisting of a three-day hospitalization Legorreta AP, Peters AL, Ossorio RC, Lopez RJ, Jatulis D,
and a six-month follow-up by telephone counseling for mild Davidson MB. Effect of a comprehensive nurse managed
type 2 diabetes and IGT. Environmental Health and Preventative diabetes program: an HMO prospective study. American Journal
Medicine 1999;4(3):122-9. of Managed Care 1996;2:1024-30.
Goddijn 1999 {published data only} Litzelman 1993 {published data only}
Goddijn PP, Bilo HJ, Feskens EJ, Groeniert KH, van der Zee KI, Litzelman DK, Slemenda CW, Langefeld CD, Hays LM,
Meyboom dJ. Longitudinal study on glycaemic control and Welch MA, Bild DE, et al. Reduction of lower extremity clinical
quality of life in patients with Type 2 diabetes mellitus referred abnormalities in patients with non-insulin-dependent diabetes
for intensified control. Diabetic Medicine 1999;16(1):23-30. mellitus. A randomized, controlled trial. Annals Internal
Medicine 1993;119(1):36-41.
Goudswaard 2002 {published and unpublished data}
Goudswaard A, Stolk RP, de Valk HW, Rutten GEH. A randomised Lo 1996 {published data only}
controlled trial of an education program by a diabetes nurse Lo R, Lo B, Wells E, Chard M, Hathaway J. The development and
in poorly controlled Type 2 diabetes patients. Diabetologia evaluation of a computer-aided diabetes education program.
2002;45(Supplement 2):A316. Australian Journal of Advanced Nursing 1996;13(4):19-27.
Hanestad 1993 {published data only} Mazzuca 1997 {published data only}
Hanestad BR, Albrektsen G. The effects of participation in a Mazzuca KB, Farris NA, Mendenhall J, Stoupa RA. Demonstrating
support group on self-assessed quality of life in people with the added value of community health nursing for clients with
insulin-dependent diabetes mellitus. Diabetes Research Clinical insulin-dependent diabetes. Journal of Community Health
Practice 1993;19(2):163-73. Nursing 1997;14(4):211-24.
Mundinger 2000 {published data only}

Mundinger MO, Kane RL, Lenz ER, Totten AM, Tsai W, Cleary PD,
et al. Primary care outcomes in patients treated by nurse
Informed decisions.
practitioners or physicians: a randomized trial. Academic Nurse Scott 1999 {published data only}
2000;17(1):8-17. Scott TL, Aubert RE. The effect of nurse case management
on diabetes self-management among HMO patients in a
Peters 1995 {published data only}
randomized trial. Diabetes 1999;48(Suppl. 1):A38.
Peters AL, Davidson MB. Management of patients with diabetes
by nurses with support of subspecialists. Health Maintenance Shamoon 1995 {published data only}
Organisation Practice 1995;9:8-14. Shamoon H, Duffy H, Fleisher N, Engel S, Saenger P,
Strelyzn M, et al. Implementation of treatment protocols in
Peters 1998 {published data only}
the diabetes control and complications trial. Diabetes Care
Peters AL, Davidson MB. Application of a diabetes managed care 1995;18(3):361-76.
program. The feasibility of using nurses and a computer system
to provide effective care. Diabetes Care 1998;21(7):1037-43. Sikka 1999 {published data only}
Sikka R, Waters J, Moore W, Sutton DR, Herman WH, Aubert RE.
Philis-Tsimikas 2000 {published data only}
Renal assessment practices and the effect of nurse case
Philis-Tsimikas A, Rivard L, Walker C, Talavera G, Grunkemeier D, management of health maintenance organization patients with
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low income Latino populations (Project Dulce) improves
care, clinical outcomes and culture bound beliefs. Circulation Sturmberg 1999 {published data only}
2000;102(18):4110. Sturmberg JP, Overend D. General practice based diabetes
clinics. An integration model. Australian Family Physician
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CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Couper 1999
Methods DESIGN: non-randomised controlled trial
SETTING: hospital and community
COUNTRY: Australia DURATION OF INTERVENTION: 6 months LENGTH OF ALLOCATION TO GROUPS: ge-
ographical region divided into two groups of equal socio-economic status ANALYSIS BY INTENTION TO
TREAT: no
Participants INCLUSION CRITERIA:

Adolescents with mean HbA1c >9.0% over preceding 12 months, age 12-17 years

Informed decisions.
Couper 1999 (Continued)

EXCLUSION CRITERIA:
not defined
NUMBERS:
intervention: 37
control: 32
GENDER (male/female):
intervention: 18/19
control: 10/22
ETHNIC GROUPS:
not described
MEAN AGE:
intervention: 14.2 (SD 1.7)
control: 14.3 (SD 1.9)
BASELINE MEASUREMENTS:
HbA1c:
intervention: 11.1% (SD 1.3)
control: 10.5% (SD 1.6)
TYPE OF DIABETES:
all type 1
DURATION OF DIABETES (YEARS):
intervention: 7.1 (SD 3.6)
control: 5.8 (SD 3.0)
NUMBERS ON INSULIN : all
LOSSES TO FOLLOW-UP:
4 out of 73
Interventions INTERVENTION:
Diabetes nurse educator gave:
- Monthly home visits of 45-60 minutes. Patients set their own goals for frequency of blood glucose
monitoring and insulin adjustment according to target blood glucose levels. Aimed to reach their indi-
vidually chosen target blood glucose and HbA1c levels at 3 and 6 months respectively. Plus received
structured education on long-term significance of metabolic control, nutrition, exercise, sick day man-
agement, hyperglycaemic events and hypoglycaemic events and insulin adjustment.
- Weekly phone contact of 5-10 minutes.
- Routine care
CONTROL:
Routine Care. Hospital visits at 3 month intervals for review of diabetes by a paediatric endocrinolo-
gist, dietician and diabetes educator and availability of 24 hour phone access for acute problems. In-
sulin dose and frequency adjusted according to standard clinical management independent of group
to which patient assigned.
LENGTH OF FOLLOW-UP: After the 6 month intervention, there was a 12 month follow-up period when
both groups received routine care.
Outcomes PRIMARY:
-HbA1c
Notes QUALITY ASSESSMENT: one or more criteria not met
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? High risk C - Inadequate
Marrero 1995
Methods DESIGN: Randomised controlled trial

Informed decisions.
Marrero 1995 (Continued)

SETTING: Paediatric outpatient clinic
COUNTRY: USA
DURATION OF INTERVENTION: unsure, possible 12 months
ALLOCATION TO GROUPS: Not described
ANALYSIS BY INTENTION TO TREAT: not applicable - no losses to follow-up
Participants INCLUSION CRITERIA: members of a paediatric diabetes clinic, at least 5 years old, diagnosed with type
1 diabetes for at least 6 months, telephone at home.
EXCLUSION CRITERIA: not stated
NUMBERS:
Intervention: 52
Control: 54
GENDER (male/female): Intervention: 31/21
Control: 32/22
ETHNIC GROUPS:
Intervention: 51 white, 1 black; Control 51: white, 3 black.
MEAN AGE:
Intervention: 13.3 (SD 4.5); Control: 13.3 (SD 4.9)
HbA1c:
Intervention: 9.4% (SD 1.9); Control: 9.9% (SD 1.6)
TYPE OF DIABETES: all type 1
Intervention: 4.3 (SD 3.4): Control: 8.0 (SD 4.7)
NUMBERS ON INSULIN: All
LOSSES TO FOLLOW-UP: Not described
Interventions INTERVENTION: Glucometer with memory and modem used. All self monitoring of blood glucose da-
ta transmitted every data from home to hospital every 2 weeks. Data reviewed by paediatric nurse
practitioners. Frequency of follow-up used an age-appropriate algorithm based on data. If mean blood
glucose within normal range, a postcard sent. If not, then telephone contact made - discussed possi-
ble regimen adjustments, need for a clinic visit or referral to dietitian, social worker or physical ther-
apist. All insulin adjustments made by nurse practitioners using dose-adjusted algorithms, designed
to achieve mean weekly blood glucose levels <141mg/dL and no more than 2 asymptomatic hypo-
glycemic episodes per week. Also attended the clinic for routine care every 3 months.
CONTROL: Standard Care. Clinic visits every 3 months. Used the same monitoring but without modem.
Regimen adjustments made by the endocrinologist over this time using the same algorithm. If HbA1c at
clinic was raised the nurse phoned patients.
LENGTH OF FOLLOW-UP: 12 months.
Outcomes PRIMARY:
- HbA1c
- Hospitalisations
- Emergency room visits.
SECONDARY:
- Quality of life

COMMENTS: unsure whether care programmes were identical.
Risk of bias
Allocation concealment? Unclear risk B - Unclear

Informed decisions.
Piette 2000a
SETTING: Community outpatients of a general medicine clinic in a county health system
COUNTRY: USA
DURATION OF INTERVENTION: unclear, possible 12 months
ALLOCATION TO GROUPS: random number tables
ANALYSIS BY INTENTION TO TREAT: yes
Participants INCLUSION CRITERIA: adults with a diagnosis of diabetes mellitus or an active prescription for a hypo-
glycaemic agent identified from medical records
EXCLUSION CRITERIA: age . >75 years, psychotic disorder, disabling sensory impairment, life expectan-
cy <12 months, primary language not English or Spanish, newly diagnosed (<6 months), planned to dis-
continue services of clinic in 12 months, no touch telephone
NUMBERS:
Intervention: 140
Control: 140
Control: 54/70
ETHNIC GROUPS: Intervention: 36 white, 59 Hispanic, 29 Other
Control: 36 white, 64 Hispanic, 24 Other.
MEAN AGE:
Intervention: 56 (SD 10) Control: 53 (SD 10)
HbA1c:
Intervention: 8.8% (SD 1.8) Control: 8.6% (SD 1.8)
Hyperglycaemic symptoms (median and IQR):
Intervention: 2 (1-4)
Control: 2 (1-4)
Hypoglycaemic symptoms (median and IQR):
Intervention: 1 (0-3)
Control: 2 (0-3)
TYPE OF DIABETES: not given
DURATION OF DIABETES (YEARS): not given
NUMBERS ON INSULIN: Intervention: 54
Control: 38
LOSSES TO FOLLOW-UP: 32/280 (16 in each group)
Interventions INTERVENTION: Automated telephone system : Structured messages of recorded statements and
queries bi-weekly to determine patients health, with a 5-8 min. assessment. Patients reported self
monitoring of blood glucose readings, self-care, perceived glycemic control and symptoms of poor
glycemic control. Interacted with system using touch-tone keypad. Also given option to participate in
interactive self-education. After several months offered additional automated self-care education calls.
A Spanish language version of the automated calls provided.
- Telephone nurse follow-up: each week nurse used reports generated by automated telephone sys-
tem to prioritise patient contacts with follow-up calls - nurse adressed problems reported during as-
sessments and provided more self-care education. Nurse also made periodic calls to follow-up on is-
sues discussed in a prior week, or check on those who rarely responded to calls. Depending on prob-
lem, nurse contacted the primary care physician. Nurse did not have ability to authorise medication
changes, but recommended dosage adjustment to primary care physician.
CONTROL: Usual care: Patients had no systematic monitoring between clinic visits or reminders of up-
coming clinic appointments. Follow-up visits at providers discretion. Additional visits at patients initia-
tive. Nurse contact over the telephone, diabetes education clinic and interpreter service available.
LENGTH OF FOLLOW-UP: 12 months
Outcomes PRIMARY:
-HbA1c
-Hypoglycemic symptoms
-Hyperglycemic symptoms
-Emergency admissions
-Hospitalisations

Informed decisions.
Piette 2000a (Continued)
Notes QUALITY ASSESSMENT: one or more criteria met

COMMENTS: unclear whether care programmes were identical.
Risk of bias
Piette 2001
SETTING: Outpatient follow-up
COUNTRY: USA
ALLOCATION TO GROUPS: sequence generated from a table of random numbers
ANALYSIS BY INTENTION TO TREAT: yes
Participants INCLUSION CRITERIA: diabetes with an active prescription for a hypoglycaemic agent
EXCLUSION CRITERIA: >75 years old, mentally ill, life expectancy <12 months, newly diagnosed,
planned to discontinue receiving care from clinic within 12 months, no touch telephone
NUMBERS:
Intervention: 146
Control: 146
Control: 138/2
ETHNIC GROUPS:
Intervention: 71 White, 32 Black, 18 Hispanic, 11 Other Control: 93 White, 17 Black, 16 Hispanic, 15 Oth-
er
MEAN AGE:
Intervention: 60 (SD 10) Control: 61 (SD 10)
HbA1c:
Hyperglycaemic symptoms: Intervention: 1.6 (SD 1.5) Control: 1.5 (SD 1.4)
Hypoglycaemic symptoms: Intervention: 1.3 (SD 1.3) Control: 1.2 (SD 1.6)
TYPE OF DIABETES: not stated
DURATION OF DIABETES: not stated
LOSSES TO FOLLOW-UP: 20 in total (Intervention 14 and Control 6)
Interventions INTERVENTION: Automated telephone disease management calls, 5-8 minutes, to record self monitor-
ing of blood glucose readings, self-care activities, perceived glycemic control, symptoms and use of
guideline-recommended medical care. Option to hear health promotion message. Nurses reviewed au-
tomated reports weekly, and followed up with calls. Nurse had ability to schedule clinic appointments.
Nurse did not have ability to authorise medication changes, but recommended dosage adjustments to
patient's primary care physician.
CONTROL: no description given. Methods reported to be similar to those in previous publications
where follow-up visits were provided at discretion of providers.
Outcomes PRIMARY:
- HbA1c
- Hypoglycemic symptoms
- Hyperglycemic symtoms

Informed decisions.
Piette 2001 (Continued)

COMMENTS: Far more diabetic outpatient visits in intervention group.
Risk of bias
Allocation concealment? Low risk A - Adequate
Thompson 1999
SETTING: Hospital diabetes clinic
COUNTRY: Canada
DURATION OF INTERVENTION: 6 months
ALLOCATION TO GROUPS: random number table
ANALYSIS BY INTENTION TO TREAT: not applicable - no losses to follow-up
Participants INCLUSION CRITERIA: receiving insulin, have undergone standard diabetes education, able to self-
monitor, under care of one of the centre's endocrinologists, poorly controlled (most recent HbA1c
greater or equal to 8.5%).
EXCLUSION CRITERIA: inability to communicate by phone, any contraindication to tight glucose con-
trol, any other serious illness, use of insulin pump.
NUMBERS:
Intervention: 23
Control: 23
Control: 12/11
ETHNIC GOUPS: not described
MEAN AGE:
Intervention: 47.5 (SD 11.8)
Control: 50 (SD 14.8)
HbA1c:
Intervention: 9.4% (SD 0.8)
Control: 9.6% (SD 1.0)
TYPE OF DIABETES: type 1: Intervention: 14
Control: 12
Control: 19.2 (SD 7.9)
NUMBERS ON INSULIN: all patients
LOSSES TO FOLLOW-UP: none reported
Interventions INTERVENTION: Individualised telephone contact by diabetes nurse educator. Calls averaged 3 per
week, lasting 15 minutes over 6 months. Insulin adjustments recommended during most calls. Re-
viewed patients records with physician as needed - typically about once every 2 weeks
CONTROL: Given supplies as needed and continued usual contact with physicians and clinic, including
HbA1c measurement every 3 months.
Outcomes PRIMARY:
- HbA1c
- proportion patients experienced 10% drop in HbA1c
SECONDARY: diabetes complications - not defined.

COMMENTS: unsure whether intervention group also had contact with physicians.

Informed decisions.
Thompson 1999 (Continued)
Risk of bias
Allocation concealment? Low risk A - Adequate
Wilson 2001
SETTING: Primary care system
COUNTRY: USA
ALLOCATION TO GROUPS: By lottery
ANALYSIS BY INTENTION TO TREAT: used last value carried forward for available clinical data
*data provided from author
Participants INCLUSION CRITERIA: not reported

EXCLUSION CRITERIA: not reported
NUMBERS:
Intervention: 295
Control: 290
GENDER: not reported
ETHNIC GROUPS: American Indian and Alskan Natives
MEAN AGES:
Intervention: 48 (SD 13)
Control: 45 (SD 14)
BASELINE MEASUREMENT:
HbA1c:
TYPE OF DIABETES: not reported
Control: 4.1 (SD 4.9)
NUMBERS ON INSULIN: not reported
LOSSES TO FOLLOW-UP: 150 lost (Intervention 48; Control 102)
Interventions INTERVENTION: Addition of a nurse care coordinator (*registered nurse and a certified diabetes edu-
cator) to primary care system. *Provided direct alterations in the patients care using standards or care
and standing orders. *Suggested changes in medication in concert with the primary care physician.
CONTROL: usual care without a care coordinator.
Outcomes PRIMARY:
- HbA1c

COMMENTS: unsure whether care programmes were identical.
Risk of bias
SD Standard deviation
IQR Interquartile range
Informed decisions.
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Ahern 2000 Before and after study
Aubert 1998 Participants may have concurrently received formal diabetes education
Barglow 1983 Trial length four months
Blonde 1999 Team approach
Brown 1995 Trial length eight weeks
Brown 1998 Trial length eight weeks
Caravalho 2000 Before and after study
Cavan 2001 Before and after study
Chan 2000 No control group
Colagiuri 1995 No control group
Corkery 1997 No nurse intervention
Davies 2000 Unclear if participants were inpatients due to diabetes or due to other conditions
de Sonnaville 1997 Team approach to education
Dougherty 1998 Compared conventional hospital and clinic management versus substantial home care with a di-
abetes specialist nurse in collaboration with the attending diabetologist for both groups. Trial is
about treatment at diagnosis.
Same study as Dougherty 1999
Dougherty 1999 Compared conventional hospital and clinic management versus substantial home care with a di-
abetes specialist nurse in collaboration with the attending diabetologist for both groups. Trial is
about treatment at diagnosis.
Same study as Dougherty 1998
Drozda 1993 Nurse involved was not a diabetes specialist nurse
Estey 1990 Trial length three months
Everett 1995 Before and after study
Feddersen 1994 Educational programme to staff
Fosbury 1997 No alterations to treatment regimens (diabetes specialist nurse was control group)
Fukuda 1999 No alterations to treatment regimens
Goddijn 1999 Before and after study
Goudswaard 2002 Individual education programme, no adjustment to treatment regimens as per protocol

Informed decisions.
Hanestad 1993 Team approach, no adjustment to treatment regimens
Heller 1988 Team approach, no adjustment to treatment regimens
Hollander 2001 No control group
Kirkman 1994 No adjustments to treatment regimens
Koproski 1997 Diabetes team intervention
Korhonen 1983 Team approach
Korhonen 1987 Team approach. No adjustment to treatment regimen
Legorreta 1996 Team approach
Litzelman 1993 No adjustment to treatment regimens
Lo 1996 Before and after study
Mazzuca 1997 Team approach
Mundinger 2000 Team approach
Peters 1995 No control group
Peters 1998 Group educational program
Philis-Tsimikas 2000 No control group
Piette 2000b No adjustment to treatment regimens
Pouwer 2001 No adjustments to treatment regimens
Raz 1988 Group education
Rettig 1986 No alteration to treatment regimens
Ridgeway 1999 Nurse and dietitian, no adjustment to treatments
Ryle 1993 No routine care
Sadur 1999 Group intervention
Scott 1999 Behavioural outcomes only
Shamoon 1995 Team approach
Sikka 1999 No alteration to treatments
Sturmberg 1999 No control group
Tu 1993 Team approach
Vrijhoef No adjustments to treatment regimens

Informed decisions.
Ward 1999 No comparison group, educational group sessions
Weinberger 1995 No adjustment to treatment regimens
Whitlock 2000 No adjustment to treatment regimens
Young 1997 Retrospective study
DATA AND ANALYSES
Comparison 1. Results
Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants
1 Results Other data No numeric data
Analysis 1.1. Comparison 1 Results, Outcome 1 Results.

Results
Study
Couper 1999 HbA1c (%): 9.7 (SD1.6)/10.3 (SD2.2) at 6 months
10.5 (SD1.8)/10.7 (SD2.0) at 12 months
10.0 (SD1.5)/10.5 (SD1.8) at 18 months.
Marrero 1995 HbA1c (%): 9.6 (SD1.9)/9.7 (SD1.5) at 6 months
10.0 (SD1.6)/10.3 (SD1.8) at 12 months.
hospitalisation: no data
emergency room: no data
QOL: no data
Piette 2000a HbA1c (%): 8.3 (SD1.9)/8.3 (SD1.9),
hypoglycaemia: 1 (0-2)/2 (1-3),
hyperglycaemia: 1 (0-2)/2 (1-3),
emergency room visits: 48%/20%,
hospitalisation: 25%/23%
Piette 2001 HbA1c (%): 8.1 (SD0.1)/8.2 (SD0.1)
hypoglycaemia: 1.1 (SD0.1)/1.4 (SD0.1)
hyperglycaemia: 1.4 (SD0.1)/1.6 (SD0.1)
Thompson 1999 HbA1c (%): 7.8 (SD0.8) / 8.9 (1.0)
proportion with 10% HbA1c: 87%/35%
(change scores)
Wilson 2001 HbA1c (%): 8.9 (SD2.1)/8.7 (SD2.2)
DATA FROM ABSTRACT AND * AUTHOR CORRESPONDENCE
APPENDICES
Appendix 1. Search strategy
Search terms

Informed decisions.
(Continued)
Unless otherwise stated, search terms are free text terms; MeSH = Medical subject heading (Medline medical index term); exp = ex-
ploded MeSH; the dollar sign ($) stands for any character(s); the question mark (?) = to substitute for one or no characters; tw = text
word; pt = publication type; sh = MeSH; adj = adjacent.
DIABETES
#1 explode 'Diabetes-Mellitus' / MeSH, all subheadings
#2 iddm or niddm
#3 #1 or #2
NURSES
#4 explode 'Nurses-' / MeSH, all subheadings
#5 explode 'Nursing-' / MeSH, all subheadings
#6 #4 or #5
DIABETES AND NURSES

#7 #3 and #6
#8 diabet* with nurs*
#9 diabet* near educator*
#10 (nurs* near case* near manage*) and diabet*
#11 #7 or #8 or #9 or #10
WHAT'S NEW
Date Event Description
1 November 2008 Amended Converted to new review format.
CONTRIBUTIONS OF AUTHORS
EMMA LOVEMAN: Protocol development, searching for trials, quality assessment of trials, data extraction, and development of final review.
PAMELA ROYLE: Searching for trials, quality assessment of trials, data extraction, development of final review.
NORMAN WAUGH: Protocol development, quality assessment of trials, data extraction, development of final review.
DECLARATIONS OF INTEREST
None known.
SOURCES OF SUPPORT
Internal sources
• National Coordinating Centre for Health Technology Assessment, UK.
External sources
• No sources of support supplied
INDEX TERMS
Medical Subject Headings (MeSH)

*Specialties, Nursing; Case Management; Diabetes Mellitus [*nursing]; Quality of Life; Randomized Controlled Trials as Topic
MeSH check words

Humans


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Cochrane

Specialist nurses in diabetes mellitus (Review)

Loveman E, Royle P, Waugh N

Loveman E, Royle P, Waugh N.

Specialist nurses in diabetes mellitus (Review)

Specialist nurses in diabetes mellitus (Review) i

Specialist nurses in diabetes mellitus

Emma Loveman1, Pamela Royle2, Norman Waugh3

Editorial group: Cochrane Metabolic and Endocrine Disorders Group.

Data collection and analysis

Specialist nurses in diabetes mellitus (Review) 1

PLAIN LANGUAGE SUMMARY

Specialist nurses in diabetes mellitus

Specialist nurses in diabetes mellitus (Review) 2

Specialist nurses in diabetes mellitus (Review) 3

Integration into health care systems METHODS

• The Cochrane Library (1981-2002);

Specialist nurses in diabetes mellitus (Review) 4

• CINAHL 1982-2002; Data extraction and management

Specialist nurses in diabetes mellitus (Review) 5

Specialist nurses in diabetes mellitus (Review) 6

Outcomes Effects of interventions

Specialist nurses in diabetes mellitus (Review) 7

Hypoglycaemic episodes DISCUSSION

Specialist nurses in diabetes mellitus (Review) 9

Corkery 1997 {published data only}

Specialist nurses in diabetes mellitus (Review) 10

Mundinger 2000 {published data only}

Specialist nurses in diabetes mellitus (Review) 12

Additional references Gafvels 1996

Characteristics of included studies [ordered by study ID]

Participants INCLUSION CRITERIA:

Specialist nurses in diabetes mellitus (Review) 13

Couper 1999 (Continued)

Notes QUALITY ASSESSMENT: one or more criteria not met

Bias Authors' judgement Support for judgement

Allocation concealment? High risk C - Inadequate

Specialist nurses in diabetes mellitus (Review) 14

Marrero 1995 (Continued)

Notes QUALITY ASSESSMENT: one or more criteria not met

Bias Authors' judgement Support for judgement

Allocation concealment? Unclear risk B - Unclear

Specialist nurses in diabetes mellitus (Review) 15

Specialist nurses in diabetes mellitus (Review) 16

Piette 2000a (Continued)

Notes QUALITY ASSESSMENT: one or more criteria met

Bias Authors' judgement Support for judgement

Allocation concealment? Unclear risk B - Unclear

Notes QUALITY ASSESSMENT: one or more criteria met

Specialist nurses in diabetes mellitus (Review) 17

Piette 2001 (Continued)

Bias Authors' judgement Support for judgement

Allocation concealment? Low risk A - Adequate

Notes QUALITY ASSESSMENT: one or more criteria met

Specialist nurses in diabetes mellitus (Review) 18

Thompson 1999 (Continued)

Bias Authors' judgement Support for judgement

Allocation concealment? Low risk A - Adequate

Participants INCLUSION CRITERIA: not reported

Notes QUALITY ASSESSMENT: one or more criteria not met