Methods

Locale: New South Wales, Australia.
Method of recruitment: Patients referred to a Diabetes Education Service (DES).
Inclusion/exclusion criteria: Diagnosed with type 2 diabetes, diagnosed for < 5 years, age < 80 yrs, speak, read and understand English, no previous formal instruction on diabetes care, not taking over 75% of the maximum dosage of oral hyopoglycaemic agents and not terminally ill.
Randomisation: No details on concealed allocation or method used.
Length of follow‐up from start of intervention: 6 and 12 months.
Blinding (Investigator (I), Patient (P), Evaluator (E), Analyst (A)): No details given.
Power analysis: no
Intention to treat: no.
Informed consent: yes.
Approval: yes

Participants

Socio‐economic background: Not given. Could be judged by referral to the DES. 74% had education up to lower high school.
Baseline numbers: Recruited = not given; Eligible= 252; Randomised= 238; Control (Minimal) = 59; Control (Group education) = 65; Intervention (Individual education) = 57; Intervention (Behavioral) = 56.
End of study numbers at 6 months: Control (Minimal) = 17; Control (Group education) = 27; Intervention (Individual education) = 29; Intervention (Behavioral) = 43.
End of study numbers at 12 months: Control (Group education) = 19; Intervention (Individual education) = 25; Intervention (Behavioral) = 39.
Dropout rate: overall at 6 months 53%, at 12 months 35%.
Age (mean or range): 58.6 years.
Ethnicity: not given.
Sex: 52.3 % females.
Number of years of diabetes: mean = 0.54 years.
Proportion of Type 2: all type 2.
Treatment given: 37% on oral hypoglycaemic medication.
Average HbA1: Individual 12.2% Group 12.1%

Interventions

The study reported four interventions involving diet, exercise, use of oral hypoglycaemic agents, urine testing, foot care and recommendations to consult opthalmologist and podiatrist.
1. Minimal (Control) ‐ Two (nurse educator and dietician) 1‐ hr sessions. Same topics as intervention groups but in less detail.
2. Group education ‐ Two 1‐hr individual sessions + 3‐day course in small groups + two 2‐hr group follow up at 3 and 9 mo. Also opportunity to attend one 2‐hr lecture.
3. Individual education ‐ Two 1‐hr individual sessions + approx. monthly for 12 months. Same topics but greater details. Opportunity to attend a 2‐hr lecture.
4. Behavioral (Intervention) ‐ series of individual visits by nurse educator + random phone calls by nurse educator. Emphasis on cognitive‐behavioural strategies and cardiovascular risks (diet, exercise and smoking).
At 6 months, Extensive and Behavioural were compared with Minimal program as control. For 12‐month comparison, Extensive Group was used as control in this review as there were no outcome reported for Minimal Program.

Outcomes

HbA1, BMI kg/m2; fasting total cholesterol, mmol/l; HDL , mmol/l; cholesterol risk ratio ( total cholesterol /HDL); systolic BP, mmHg; diastolic BP, mmHg; knowledge test (DKN), 15‐point scale; satisfaction ,18 item scale developed by authors.

Notes

Group education had components in individual sessions. Group patients received more overall contact than all other groups. Participants in Minimal program were not measured at 12 months. Therefore for analysis only individual and group were used

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Locale: Spain
Method of recruitment: Patients from primary care.
Inclusion/exclusion criteria: Diagnosed with type 2 diabetes at least six months before the start of trial and had not received group education. Those over 75 years, or having sensory psychological and/or physical deficiencies and those not monitored in primary care were excluded.
Randomisation: Unsure of concealment or method used.
Length of follow‐up from start of intervention: 12 months.
Blinding (Investigator (I), Patient (P), Evaluator (E), Analyst (A)): unsure.
Power analysis: unsure.
Intention to treat: no.
Informed consent: unsure.
Approval: unsure.

Participants

Socio‐economic background: Unsure.
Baseline numbers: Recruited = 93; Eligible= 79; Randomised= 79; group= 38; Individual = 41.
End of study numbers: group= 35; Individual= 33.
Dropout rate: 14%.
Age: mean = 65 years.
Ethnicity: unclear.
Sex: 35% males in individual education and 64.7% males in group education
Number of years of diabetes: diagnosed at least 6 months prior to study
Proportion of Type 2: all.
Oral hypoglycaemics: individual 60% and group 51.4%
Average HbA1c at baseline: Intervention ‐ 6.6% and group 7.2%

Interventions

Control: Group education.
Intervention: Individual education.
Each received 3 sessions, seperated by one week, 40 minutes, content the same

Outcomes

HbA1c%; HDL cholesterol, mmol/l; LDL cholesterol, mmol/l; BMI, kg/m2; systolic BP, mmHg; diastolic BP, mmHg; diabetes knowledge.

Notes

There were almost twice as many women in Intervention group compared to that in Control group. Published in Spanish. Data extracted from summary, text and tables.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Locale: The Netherlands
Method of recruitment: Recruited from 57 practices, 78 GPs
Inclusion/exclusion criteria: Type 2 diabetes, treated by primary care only, aged less than 76 years, with HbA1c >= 7.0% while taking the maximum feasible dosages of two different oral hypoglycaemic agents. Excluded are those with severe co‐morbidity, not fluent in Dutch, requirement for insulin therapy in the short term on account of severe hyperglycaemic symptoms.
Randomisation: By independent trial centre. Method used was computer‐generated random assignment with blocks of 8 patients at a time.
Length of follow‐up from start of intervention: 6 and 18 months
Blinding (Investigator (I), Patient (P), Evaluator (E), Analyst (A)):
Power analysis: yes
Intention to treat: yes; missing values represented last previous value.
Informed consent: yes
Approval: yes

Participants

Socio‐economic background: Participants from all levels of community.
Sampling: Recruitment to randomisation =76.3%. Randomisation to completion of trial = 86.2%.
Baseline numbers: Recruited = 1810; Eligible = 76; Randomised = 58; Control = 30; Intervention = 28.
End of study numbers: Control = 26; Intervention = 24.
Dropout rate: 14%
Age: average = 60.5 years
Ethnicity: Dutch
Sex: 52 % females
Number of years of diabetes: 7.5 years.
Proportion of Type 2: all.
Medication: 22% on diet only, 12% on insulin,66% oral hypoglycaemic agents.
Average HbA1c ‐ Intervention 8.2%, Control 8.8%

Interventions

Intervention: Collaborative, mixed educational intervention by two diabetes nurses. Focus on diabetes, compliance with medication, importance of physical exercise, losing weight and nutritional advice. 6 sessions during the 6 month period, total contact time of approximately 2.5 hours

Control: Usual care by GP. GP instructed not to alter medication unless a patient developed severe hyperglycaemic symptoms

Outcomes

HbA1c, %. body weight

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Locale: UK.
Method of recruitment: Recruited through Manchester Diabetes Centre or one of 10 mini‐clinics.
Inclusion/exclusion criteria: British Pakistanis with Type 2 diabetes. Excluded if enrolled in another study, too ill, if they or spouse had received formal education in the last 6 months
Randomisation: Sequential and using concealed envelope and random number generator.
Length of follow‐up from start of intervention: 6 months
Blinding (Investigator (I), Patient (P), Evaluator (E), Analyst (A)): unclear
Power analysis: yes
Intention to treat: no
Informed consent: yes
Approval: yes

Participants

Socio‐economic background: Pakistani migrant and many with little knowledge of English and many illiterate.
Baseline numbers: Recruited = na; Eligible= na; Randomised= 201; Control= 112; Intervention = 89.
End of study numbers: Control= 86; Intervention= 106.
Return to follow‐up rate: 95%
Age (mean or range): Intervention 52 years, control 54 years
Ethnicity: Pakistani
Sex: 46% males in intervention and 47% male in control group
Number of years of diabetes: unknown.
Proportion of Type 2: all.
HbA1c: Intervention 8.4% and control 8.6%

Interventions

Intervention: Face‐to‐face by diabetes nurse using flash cards on various topics (diabetic diet, glucose monitoring and diabetic complications). The educational services were offered in Punjabi or Urudu. 20 minutes with each patient

Control: usual care.

Outcomes

HbA1c, %; knowledge on complications; food knowledge score.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Locale: USA.
Method of recruitment: Through advertisements and announcement with offer of free & comprehensive diabetes evaluation. Two large and 2 small communities were targeted based on area codes.
Inclusion/exclusion criteria: Diagnosed with diabetes Type 2, and those with Type 1 were excluded.
Randomisation: No indication of concealed allocation but random number used.
Length of follow‐up from start of intervention: 12 months.
Blinding (Investigator (I), Patient (P), Evaluator (E), Analyst (A)): not blinded.
Power analysis: no
Intention to treat: no
Informed consent: yes
Approval: yes

Participants

Socio‐economic background: Those who responded to the advertisement for the service or incentive or both.
Baseline numbers: Recruited = 431; Eligible= 376; Randomised= 376; Control= 190; Intervention = 186.
End of study numbers: Control= 156; Intervention= 158.
Return to follow‐up rate: 84%
Age (mean or range): Control = 64 years; Intervention = 65 years.
Ethnicity: not available
Sex: Control = 27% and Intervention = 12% females.
Number of years of diabetes: Control = 10 years and Intervention = 9 years.
Proportion of Type 2: all.
Average HbA1c: Intervention 7.7% & control 7.9%

Interventions

Control: usual care.
Intervention: Face‐to‐face or via telephone by specialist nurse educator. Approx 4 hours of professional time per patient
Individual education and counselling session to encourage the patient to consult physician about identified problem.
High risk subsets for each outcome were defined as follows: HbA1c >= 7.5%, cholesterol >= 6.22mmol/l, systolic blood pressure >= 140 mmHg and systolic blood pressure >= 90 mmHg.

Outcomes

HbA1c, %; total cholesterol, mmol/L; diastolic BP, mmHg; systolic BP, mmHg.

Notes

intervention timing not clear;

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Locale: Hong Kong
Method of recruitment: from 3 regional diabetic centres in Hong Kong
Inclusion/exclusion criteria: HbA1c 8.1 ‐ 11%, age range 35 ‐ 70 years
Randomisation: coin tossing
Length of follow‐up from start of intervention: 1 year
Blinding (Investigator (I), Patient (P), Evaluator (E), Analyst (A)): physicians blinded
Power analysis: yes
Intention to treat: no
Informed consent: not stated
Approval: not stated

Participants

Socio‐economic background:
Baseline numbers: 90 in each group
End of study numbers: 2 control patients defaulted follow‐up
Return to follow‐up rate: 99%
Age (mean or range): Intervention 55, control 56 years
Ethnicity: Chinese
Sex: Intervention 48.9% male, control group 38.6% male
Number of years of diabetes: not stated
Proportion of Type 2: all.
Average HbA1c: Intervention 8.6%, control 8.4%

Interventions

Both groups followed up every 10 ‐ 14 weeks
Intervention: 5 x 30 minute visits after follow‐up by physicians, by nurse educator, concentrated on CV risk factors
Control: same medical care except no nursing reinforcement

Outcomes

fasting glucose, HbA1c, body mass index, waist circumference, blood pressure and lipid profiles

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

D ‐ Not used

Methods

Locale: USA.
Method of recruitment: Patients referred to Diabetes Centre by primary care provider over a 2‐year period from April 1997 to July 1999.
Inclusion/exclusion criteria: Type 2. Newly diagnosed or previously diagnosed but without prior formal diabetes education. Patients treated with medical nutritional therapy and /or medical therapy.
Randomisation: randomisation in blocks of 3 patients to Control or Intervention during first year and in the following year, in blocks of 10 patients. Method of concealment or allocation was unclear.
Length of follow‐up from start of intervention: 6 months.
Blinding (Investigator (I), Patient (P), Evaluator (E), Analyst (A)): all unclear.
Power analysis: not presented.
Intention to treat: no.
Informed consent: yes
Approval: yes

Participants

Source of patients: referred by primary care providers. Newly diagnosed diabetes or no history of prior systematic diabetes education
Socio‐economic background: not clear.
Baseline numbers: Randomised= 170; Control= 87; Intervention = 83.
End of study numbers: Control= 43; Intervention= 49.
Retention to follow‐up: 54%
Age (mean or range): 52.5 years
Ethnicity: 93% Caucasians
Sex: 66% females
Number of years of diabetes: 0.9 years.
Proportion of Type 2: All
Average HbA1c: Group 9% and individual 8.2%

Interventions

General: Four sessions were given to both groups. 5‐7 hours. Contents covered topics on education including diet, glucose monitoring and foot care. Participants in control groups received in groups of 4 to 8. Individuals in intervention group had shorter sessions to cover the same material. Interventions in both settings emphasized empowering the patient, by increasing knowledge, facilitating self‐management behaviour change

Outcomes

HbA1c, %; weight, kg; BMI, kg/m2; knowledge test (14pts); exercise (times/week); exercise duration (min/week); ATT‐19 ‐ Psychosocial adjustment and attitudes towards diabetes using 19‐point score; SF‐36 mental scale that measured mental health related quality of life; SF‐36 physical scale that measured physical health related quality of life.

Notes

Allocation in blocks of 6 or 10 may be biased. Groups attending clinic may be relatives, friends of similar socio‐economic background.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Locale: Japan
Method of recruitment: outpatients of Department of diabetes and Metabolism, University Hospital.
Inclusion/exclusion criteria: adults, between ages of 20 ‐ 75, diagnosed with type 2 diabetes; HbA1c between 6.5% and 8.5%, who could not use insulin.
Randomisation: randomised but no details on concealment or methods.
Length of follow‐up from start of intervention: 1 year
Blinding (Investigator (I), Patient (P), Evaluator (E), Analyst (A)): not blinded.
Power analysis: yes with 64 patients in each group, there was an 80% power to detect 0.5% difference in the change in HbA1c
Intention to treat: no.
Informed consent: not stated
Approval: Yes

Participants

Socio‐economic background: not stated
Baseline numbers: intervention 67 and control 67
End of study numbers at 12 months: intervention 59 control 61
Dropout rate: 10%
Age (mean or range): Intervention 61, Control 62
Ethnicity: Japanese
Sex: 65% males
Number of years of diabetes: mean = intervention 10 years, control 13 years.
Proportion of Type 2: all.
Treatment given: 89.6% on oral hypoglycaemic medication in intervention and 82.1% in control
Average HbA1c: Individual 7.3% Group 7.4%

Interventions

Intervention: received normal medical consultation and one‐to‐one counselling with a certified expert nurse at monthly hospital visits for 1 year. Features are patient participation in goal setting, personalized strategies and goal setting.
Control: received usual care by same practitioners at hospital clinic

Outcomes

HbA1c, HRQOL with SF‐36Japanese Version, PAID , cognitive modification (3 items), behavioural modification (1 item) and overall satisfaction with counselling (1 item)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Locale: USA.
Method of recruitment: Patients enrolled at single diabetes centre.
Inclusion/exclusion criteria: Females, diagnosed with type 2 diabetes; 30 to 70 yrs age; cleared for exercise by primary care provider; had no advanced complications of diabetes; HbA1c >7%; fluent in English and had previously participated in diabetes education.
Randomisation: randomised but no details on concealment or methods.
Length of follow‐up from start of intervention: 6 months.
Blinding (Investigator (I), Patient (P), Evaluator (E), Analyst (A)): all unclear.
Power analysis: no.
Intention to treat: no.
Informed consent: yes.
Approval: yes.

Participants

Socio‐economic background: wide cover, low to middle income, mean of 12.6 yrs of education.
Baseline numbers: Recruited = 81; Eligible= 53; Randomised= 53; Control= 24; Intervention = 29.
End of study numbers: Control= 23; Intervention= 26.
Retention to follow‐up rate: 92%
Age (mean or range): 57.6 years
Ethnicity: 89% white, 11% Hispanic.
Sex: all females
Number of years of diabetes: 2.7 years.
Proportion of Type 2: all.
Mean HbA1c 7.7%

Interventions

Control: standard diabetes care at 3 ‐ 4 month intervals. Providers nurse practitioners, internists, endocrinologists and family practice specialists
Intervention: Individualised 6 nurse‐coaching sessions over 6 months. Included topics were assessment, education reinforcement (cognitive component), problem solving (behavioural component) and psychosocial support (affective component).

Outcomes

HbA1c, %; BMI, kg/m2; self management on diet, 5‐point scale; self management on exercise, min/mo; distress‐ PAID score; integration ‐ TDQ score., treatment satisfaction DTSQc

HbA1c DCA 2000 analyzer

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

High risk

C ‐ Inadequate