Understanding Artificial Pancreas Systems: Results from a 24-Month Trial

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Non-randomized (moderate): Randomization not used or not reported

Open-label or unblinded (moderate): No blinding reported

−0.40 mmol/L (95% CI −0.51 to −0.28, p<0.001)

Fasting plasma glucose reduced significantly by −0.40 mmol/L (95% CI −0.51 to −0.28, p<0.001) in the Co-HELP group compared to usual care at 12 months.

−0.58 mmol/L (95% CI −0.91 to −0.24, p<0.001)

2-hour post-glucose reduced significantly by −0.58 mmol/L (95% CI −0.91 to −0.24, p<0.001) in the Co-HELP group compared to usual care at 12 months.

−0.24% (95% CI −0.34 to −0.15, p<0.001)

HbA1c reduced significantly by −0.24% (95% CI −0.34 to −0.15, p<0.001) in the Co-HELP group compared to usual care at 12 months.

24.6% vs 3.4% achieved ≥5% weight loss, p<0.001

Greater proportion of Co-HELP participants (24.6%) achieved ≥5% weight loss compared to usual care (3.4%, p<0.001) at 12 months. Between-group mean difference for weight was not explicitly reported in numeric terms, but the proportion achieving clinically significant weight loss was substantially higher.

−2.44 cm (95% CI −4.75 to −0.12, p<0.05)

Waist circumference reduced significantly by −2.44 cm (95% CI −4.75 to −0.12, p<0.05) in the Co-HELP group compared to usual care at 12 months.

−2.63 mmHg (95% CI −3.79 to −1.48, p<0.01)

Diastolic blood pressure reduced significantly by −2.63 mmHg (95% CI −3.79 to −1.48, p<0.01) in the Co-HELP group compared to usual care at 12 months. Systolic blood pressure was also measured but the significant result was for diastolic BP.

+0.12 mmol/L (95% CI 0.05 to 0.13, p<0.01)

HDL cholesterol increased significantly by +0.12 mmol/L (95% CI 0.05 to 0.13, p<0.01) in the Co-HELP group compared to usual care at 12 months.

PCS +6.51 (95% CI 5.21-7.80, p<0.001); MCS +7.79 (95% CI 6.44-9.14, p<0.001)

Health-related quality of life improved significantly in both physical (PCS: +6.51 points, 95% CI 5.21 to 7.80, p<0.001) and mental (MCS: +7.79 points, 95% CI 6.44 to 9.14, p<0.001) components. Matched to OUT023 'Quality of life' as the closest available reference, though specific breakdown into PCS and MCS is not captured in the reference.

60.7% vs 32.2% achieved >600 MET-min/wk, p<0.001

Significantly more participants in the Co-HELP group (60.7%) achieved physical activity of >600 MET-min/week compared to usual care (32.2%, p<0.001) at 12 months. The between-group mean difference for MET-min/week was not reported in numeric terms.

The Co-HELP (Community-Based Healthy Lifestyle Intervention Program) is a culturally adapted community-based lifestyle programme for adults with prediabetes in Malaysia. It includes 12 group sessions and 2 individual counseling sessions, delivered through community volunteers, targeting diet, physical activity, and behaviour modification. This closely matches the class-level 'Lifestyle intervention for prediabetes' intervention in the reference database.

Positive: 9; Negative: 0; No effect: 0; Mixed: 0

Extracted 9 outcome signals across the study

All primary outcomes (fasting glucose, 2-hour glucose, HbA1c) showed statistically significant improvements. Most secondary outcomes also showed significant positive changes. No negative or null outcomes were reported for the main comparisons.

↓ Fasting glucose −0.40 mmol/L, HbA1c −0.24%, and 2-hour glucose −0.58 mmol/L vs usual care (all p<0.001)

↓ Diastolic BP −2.63 mmHg, waist −2.44 cm; ↑ HDL cholesterol +0.12 mmol/L

Mostly intermediate or surrogate outcomes

Co-HELP significantly improved multiple glycaemic, anthropometric, and quality of life outcomes in adults with prediabetes

24.6% of Co-HELP participants achieved ≥5% weight loss vs 3.4% in usual care (p<0.001)

60.7% achieved >600 MET-min/week physical activity vs 32.2% in usual care (p<0.001)

Idris MHI, Mohd Salehuddin S, Talib RA, et al. Effects of a community-based healthy lifestyle intervention program (Co-HELP) among adults with prediabetes in a developing country: a quasi-experimental study. PLOS ONE. 2016;11(12):e0167123. doi:10.1371/journal.pone.0167123

Non-randomised (quasi-experimental) design with potential selection bias

Uneven group sizes (122 vs 146) due to non-random allocation

Single geographic region in Malaysia — may not generalise broadly

A community-based lifestyle programme in Malaysia helped adults with prediabetes lower blood sugar, blood pressure, and weight, and improved quality of life over 12 months.

↑ Quality of life: physical +6.51, mental +7.79 points (both p<0.001)

Twelve group-based sessions and two individual counselling sessions over 12 months, delivered by trained community volunteers

Co-HELP community-based lifestyle intervention

Usual care

Includes self-reported outcomes (moderate): Self-reported outcomes used

Limited safety reporting (moderate): Safety reporting depth: not_reported

No post-intervention follow-up (moderate): 0 weeks of follow-up after treatment ended

Non-randomized study (moderate): Randomization not reported or not used

Community lifestyle programme improves multiple diabetes risk factors in adults with prediabetes

This study tested a community lifestyle programme for adults with prediabetes in Malaysia. After 12 months, people in the programme had lower blood sugar, better cholesterol, smaller waists, and improved quality of life compared to those receiving usual care. The programme was delivered through existing community volunteers.

The quasi-experimental design means participants were not randomly assigned, so differences at baseline may have influenced results

The programme was delivered through community volunteers, which could affect consistency compared to professional delivery

Results were achieved in a specific Malaysian suburban context and may vary in other settings

The programme was relatively intensive with 12 group sessions plus 2 individual sessions over 12 months

Community-based lifestyle intervention (Co-HELP) for adults with prediabetes in Malaysia

Community lifestyle programme improves multiple diabetes risk factors in adults with prediabetes

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