# Abstract

 

## Objectives Our objective was to evaluate the effectiveness of peer-led self-management education in improving glycaemic control in patients with type 2 diabetes in a low-income country (Mali). 

## Methods We conducted an open-label randomised controlled trial. A total of 151 adults (76% women, mean age 52.5) with type 2 diabetes (HbA1c≥8%), treated in the diabetes consultation units of two secondary health centres in Bamako, were allocated to peer-led structured patient education (n = 76) or conventional care alone (n = 75). The intervention group received 1 year of culturally tailored structured patient education (3 courses of 4 sessions) delivered in the community by five trained peer educators. Both groups underwent conventional diabetes monitoring and follow-up. Primary outcome was the mean absolute change in HbA1c from baseline to 12 months. 

## Results 177 education sessions were delivered to the intervention group. Patient attrition was 8%. From baseline to 12 months, the decrease in HbA1c levels was 1.05% (SD = 2.0; CI95%: 1.54;-0.56) in the intervention group compared with 0.15% (SD = 1.7; CI95%: -0.56; 0.26) in the control group, p = 0.006. Mean BMI change was -1.65 kg/m2 (SD = 2.5; CI95%: -2.25; -1.06) in the intervention group and +0.05 kg/m2 (SD = 3.2; CI95%: -0.71; 0.81) in the control group, p = 0.0005. Mean waist circumference decreased by 3.34 cm (SD = 9.3; CI95%: -5.56;-1.13) in the intervention group and increased by 2.65 cm (SD = 10.3; CI95%: 0.20; 5.09) in the control group, p = 0.0003. 

## Conclusions Peer-led structured patient education delivered over 1 year to patients with poorly controlled type 2 diabetes in Mali yielded substantial improvements in glycaemic control and anthropometric parameters. This is of importance for the scaling up of efficient interventions in low-resource settings in the future. 

## Trial registration ClinicalTrials.gov [NCT01485913](#) # Results From July, 21st to September, 30^th^, 2011, we included 151 patients in the study: 76 in the intervention group and 75 in the control group ([Fig 1](#)). Study participants were mostly female (n = 115, 76.2%) and the majority were overweight (BMI> = 25: n = 110, 72.9%). A third of the sample presented high blood pressure (n = 51, 33.8%). The mean HbA1c level was 10.6% (standard deviation (sd = 1.8) and 10.8% (sd = 1.9) in the intervention arm and the control arm, respectively. At baseline, patients' characteristics in the 2 groups were similar ([Table 1](#)). Educational courses took place between October and December 2011, April and July 2012, August-December 2012. The follow-up of participants from both groups took place between 1^st^ October 2011 and 20 ^th^ February 2013. The reasons for this slight delay in scheduled courses and follow-ups were that due to political events in Mali during 2012 we had to post pone the second and third education session courses in the intervention arm, and the corresponding follow-ups (February 2012, July 2012, January 2013). The patterns of withdrawal are documented in [Fig 1](#). Overall, the 5 PEs facilitated 177 educational sessions with a mean of 6.4 patients per group session in the intervention group. Among intervention patients, 70 attended the 3 courses. <figure> 10.1371/journal.pone.0191262.g001 <p><img src="" /></p> <figcaption>Flow chart of participants.<br /> ST2EP trial.</figcaption> </figure> ::::table-wrap

10.1371/journal.pone.0191262.t001

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## Clinical and biological characteristics at baseline of participants allocated to peer-led structured patient education (intervention) or to conventional care alone (control).

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```
                               Total (n = 151)   Intervention (n = 76)   Control (n = 75)
```

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Gender (female, n, %) 115 (76.2) 57 (75.0) 58 (77.3)
Age, years 52.5 (9.8) 53.9 (9.8) 51.1 (9.6)
BW, kg 78.2 (15.6) 77.7 (16.4) 78.7 (14.7)
BMI, kg/m^2^ 28.6 (5.4) 28.3 (5.4) 28.8 (5.5)
Waist circumference, cm 93.9 (11.9) 93.7 (12.1) 94.1 (11.6)
BMI 25.0--29.9 48 (31.8%) 21 (27.6%) 27 (36.0%)
BMI≥30.0 62 (41.1%) 34 (44.7%) 28 (37.3%)
BP Diastolic, mm Hg 81.6 (10.6) 82.9 (10.5) 80.3 (10.6)
BP Systolic, mm Hg 129.9 (23.9) 132.8 (26.9) 127.1 (20.1)
HbA1c, % 10.7 (1.8) 10.6 (1.8) 10.8 (1.9)
No treatment / Diet only 13 (8.6%) 7 (9.2%) 6 (8.0%)
Oral anti-diabetic only 92 (60.9%) 45 (59.2%) 47 (62.7%)
Insulin only 32 (21.2%) 15 (19.4%) 17 (22.7%)
Insulin and oral anti-diabetic 14 (9.3%) 9 (11.8%) 5 (6.7%)
Knowledge score 5.2 (1.2) 5.2 (1.2) 5.2 (1.3)

Values are n (%) or mean (SD). BMI = Body Mass Index. BW = Body weight.
BP = Blood pressure:::: As shown in [Table 2](#), the reduction in HbA1c levels between baseline and 12 months was higher (p = 0.006) in the intervention group (-1.05 [sd = 2.0]) than in the control group (-0.15 [sd = 1.7]). The effect size was 0.48 (CI95%: 0.14--0.81). BMI and WC had also improved at 12 months in the intervention group. Similarly, in this latter group, the proportion of patients receiving insulin decreased slightly from 28.9% (n = 22) to 24.3% (n = 17) during follow-up in the intervention group (p = 0.0003) ([Table 3](#)). ::::table-wrap
10.1371/journal.pone.0191262.t002

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## Changes in biomedical outcomes from baseline to 12 months.

The ST2EP trial in Mali. Data are mean (CI 95%).
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```
                         Intervention group    Control group        p-value
                         (n = 70)               (n = 70)              
```

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Body Mass Index, kg/m^2^ -1.65 (-2.25; -1.06) 0.05 (-0.71; 0.81) 0.0005

Waist circumference, cm -3.34 (-5.56;-1.13) 2.65 (0.20;5.09) 0.0003

Systolic BP, mm Hg -6.46 (-11.63;-1.28) 3.57 (-0.17;7.31) 0.003

Diastolic BP, mm Hg 0.40 (-2.27;3.07) 2.00 (-0.77;4.77) 0.36

HbA1c, % -1.05 (-1.54; -0.56) -0.15 (-0.56; 0.26) 0.006

Knowledge score 1.06 (0.70;1.42) 0.61 (0.23;0.99) 0.17
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10.1371/journal.pone.0191262.t003

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## Anti-diabetic and anti-hypertensive treatment in intervention group and in control group at baseline and at 12-month follow-up (FU).

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```
                               Total         Intervention group   Control     p-value
                                                                  Group        
```

______________________________________________________________________

**At baseline** **n = 151** **n = 76** **n = 75**

Insulin 43 (28.5%) 22 (28.9%) 21 (28.0%) 0.90

OAD only[\*](#) 108 (71.5%) 55 (72.4%) 53 (70.7%) 0.82

Combination of 2 OADs[\*\*](#) 108 (71.5%) 55 (72.4%) 53 (70.7%) 0.82

Calcium channel blockers 7 (4.6%) 5 (6.6%) 2 (2.7%) 0.44

Beta Blockers 4 (2.6%) 2 (2.6%) 2 (2.7%) 0.99

Angiotensin Receptor Blockers 23 (15.2%) 15 (19.7%) 8 (10.7%) 0.12

Central 1 (0.7%) 1 (1.3%) 0 (0.0%) 1.00

Diuretics 1 (0.7%) 1 (1.3%) 0 (0.0%) 1.00

**At the end of FU** **n = 140** **n = 70** **n = 70**

Insulin 36 (25.7%) 17 (24.3%) 19 (27.1%) 0.70

OAD[\*](#) only 102 (72.9%) 51 (72.9%) 51 (72.9%) 1.00

Combination[\*\*](#) of 2 OADs 100 (71.4%) 50 (71.4%) 50 (71.4%) 1.00

Calcium channel blockers 11 (7.9%) 6 (8.6%) 5 (7.1%) 0.75

Beta Blockers 6 (4.3%) 3 (4.3%) 3 (4.3%) 1.00

Angiotensin Receptor Blockers 36 (25.7%) 22 (31.4%) 14 (20.0%) 0.12

Central 0 (0.0%) 0 (0.0%) 0 (0.0%) NC



## Diuretics 3 (2.1%) 1 (1.4%) 2 (2.9%) 1.00

Data are n (%)

\*OAD: Oral Antidiabetic therapy comprising metformin and/or
sulfonylurea and/or alpha-glucosidase inhibitors.

\*\*Combination of 2 OAD: Combination of metformin and sulfonylurea:::: The evolution of HbA1c levels between baseline and 12 months is presented in [Fig 2](#). The decrease in HbA1c levels was more important in the intervention group, especially after month 6. Similarly, the evolution of BMI and WC was more favourable in the intervention group than in the control group (p = 0.001 for BMI and WC; [Fig 3](#)). Patients' knowledge scores improved slightly, mostly due to their increased knowledge of symptoms, treatment and hypoglycaemia management ([Table 4](#)). No positive change in the diet diversity score as a crude index of diet quality was recorded in intervention patients. The number of meals remained the same. However, qualitative changes in the diet were noted from dietary recalls at baseline and at the end of follow-up in the various meals and snacks eaten during the day: meat and fish, as well as peanut and onion sauce, consumption was more abundant at baseline, the number of patients who mentioned having a morning snack decreased by more than half at follow-up, <figure> 10.1371/journal.pone.0191262.g002 <p><img src="" /></p> <figcaption>Evolution of HbA1c levels between baseline and 12 months–levels in % and 95% confidence interval.</figcaption> </figure> <figure> 10.1371/journal.pone.0191262.g003 <p><img src="" /></p> <figcaption>Evolution of body mass index, waist circumference and blood pressure between baseline and 12 months– 95% confidence interval.</figcaption> </figure> ::::table-wrap
10.1371/journal.pone.0191262.t004

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## Knowledge score changes between baseline (T0) and end of follow-up (12 months) in intervention group (n = 70) and in control group (n = 70).

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Knowledge score domains (EFU--T0) Total Intervention group Control p-value
Group

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Symptoms 0.04 (0.40) 0.13 (0.39)[\*](#) -0.06 (0.39) 0.003

Treatments 0.00 (0.47) 0.03 (0.46) -0.04 (0.47) 0.39

Treatments adherence 0.10 (0.24)[\*](#) 0.12 (0.22)[\*](#) 0.07 (0.26)[\*](#) 0.17

Sign of gravity 0.00 (0.24) 0.00 (0.24) 0.01 (0.25) 0.73

Symptoms of hypoglycemia 0.12 (0.31)[\*](#) 0.12 (0.31)[\*](#) 0.12 (0.31)[\*](#) 0.94

Hypoglycemia management 0.04 (0.43) 0.09 (0.43) 0.00 (0.44) 0.26

Diabetic foot 0.02 (0.22) 0.02 (0.23) 0.02 (0.22) 0.92

Physical activity 0.39 (0.54)[\*](#) 0.40 (0.53)[\*](#) 0.37 (0.55)[\*](#) 0.78



## Diet 0.11 (0.21)[\*](#) 0.13 (0.22)[\*](#) 0.10 (0.20)[\*](#) 0.40

Changes are scores at end of follow-up minus scores at baseline. Data
are mean (SD).

- p\<0.05 for increase between baseline and end of FU.::::


Extracted trial result:
Outcome: Mean BMI change (continuous)
Intervention: to peer-led structured patient education
Comparator: conventional care alone
Intervention mean: -1.65
Intervention standard deviation: 2.5
Comparator mean: 0.05
Comparator standard deviation: 3.2
Notes: SDs found in abstract while group sizes and means found in table 2