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

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Open-label or unblinded (moderate): Open-label design

No power calculation reported (low): No power calculation reported

diabetes developed in 17.1% (79/463) of control participants and 14.9% (68/456) of intervention participants (RR 0.88, 95% CI 0.66-1.16, p=0.36)

Diabetes incidence was 14.9% in intervention vs 17.1% in control at 24 months (absolute risk reduction of 2.2 percentage points, RR 0.88, 95% CI 0.66-1.16, p=0.36). The reduction was not statistically significant.

greater reduction in IDRS score (mean difference: -1.50 points, p=0.022)

Intervention participants had a significantly greater reduction in IDRS score compared to control (mean difference: -1.50 points, p=0.022), indicating reduced diabetes risk.

Alcohol use was significantly reduced in the intervention group compared to control (RR 0.77, p=0.018), indicating reduced alcohol consumption as a behavioral risk factor.

greater increase in fruit and vegetable intake (≥5 servings/day) (RR 1.83, p=0.008)

Intervention participants had a significantly greater increase in fruit and vegetable intake (≥5 servings/day) compared to control (RR 1.83, p=0.008), indicating improved dietary quality.

physical functioning score of the HRQoL scale (mean difference: 3.9 score, p=0.016)

The physical functioning subscale of the HRQoL scale showed significant improvement in the intervention group compared to control (mean difference: 3.9 score, p=0.016), indicating better physical health-related quality of life.

Community-based peer-support lifestyle intervention for diabetes prevention delivered by trained lay peer leaders over 12 months, including group sessions and community activities

Positive: 5; Negative: 0; No effect: 0; Mixed: 0

Direction counts recalculated from intervention outcomes due to mismatch with AI-provided counts.

Extracted 5 outcome signals across the study

Primary outcome (diabetes incidence) showed non-significant reduction. Four of five secondary outcomes showed significant improvement in the desired direction (IDRS score, alcohol use, fruit/vegetable intake, physical functioning).

Direction counts were recalculated from extracted outcomes because the AI-provided totals did not match.

Diabetes incidence: ↓ non-significant (14.9% vs 17.1%, RR 0.88, p=0.36)

Study Evidence Depth: High-depth evidence

Peer-support lifestyle program improved diet quality and physical functioning at 24 months

Alcohol use was significantly reduced in the intervention group

Diabetes incidence was lower but the reduction was not statistically significant

Sathish T, Oldenburg B, et al. A peer-support lifestyle intervention for preventing type 2 diabetes in India: A cluster-randomized controlled trial of the Kerala Diabetes Prevention Program. PLoS Med. 2018;15(6):e1002575.

Diabetes incidence reduction was not statistically significant

No adjustment for multiple comparisons (increases type I error risk)

24-month follow-up may be insufficient to detect diabetes prevention effects

A low-cost peer-support lifestyle program improved dietary intake, alcohol use, and physical functioning but did not significantly reduce diabetes incidence at 24 months in high-risk Indians.

12-month community-based peer-support program comprising 15 group sessions (12 of which were led by trained lay peer leaders)

Peer-support lifestyle intervention

Education booklet

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

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

Open-label or unblinded study (moderate): Open-label design

Peer-support lifestyle program reduces diabetes risk factors but not diabetes incidence in high-risk Indians

This cluster-randomized trial tested a community-based peer-support lifestyle program in 1,007 high-risk Indian adults. The program improved diet, reduced alcohol use, and enhanced physical functioning, but the 14.9% vs 17.1% reduction in diabetes incidence was not statistically significant.

The primary outcome (diabetes incidence) did not reach statistical significance

Significant secondary outcomes were not adjusted for multiple comparisons

Results may not generalize to higher-resource settings or different delivery models

The peer-support model is promising for scalability at very low cost (US$22.50/participant)

Peer-support lifestyle intervention for type 2 diabetes prevention in high-risk Indian adults

Adults aged 30-60 years with elevated diabetes risk (IDRS ≥60) in LMIC settings

Peer-support lifestyle program reduces diabetes risk factors but not diabetes incidence in high-risk Indians

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