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

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

HR 0.12 [95% CI 0.05-0.28] for retainers vs standard care; ITT HR 0.74 [95% CI 0.48-1.14], p=0.18

The primary ITT analysis showed no significant reduction (HR 0.74, 95% CI 0.48-1.14, p=0.18). However, per-protocol analyses revealed a strong dose-response: retainers (all sessions) had HR 0.12 (95% CI 0.05-0.28) and those attending ≥1 refresher had HR 0.38 (95% CI 0.24-0.62) versus standard care, though these analyses are subject to selection bias.

Retainers had 0.16% lower HbA1c than standard care at 3 years

Retainers had HbA1c values that were on average 0.16% lower than those who received standard care at 3 years. This appeared to be driven by an increase in HbA1c in the standard care group rather than a decrease in the intervention group.

Retaining (attending all sessions) was associated with statistically significant improvements in fasting glucose compared to standard care and nonretainers at 3 years.

Retaining was associated with statistically significant improvements in 2-hour glucose compared to standard care and nonretainers at 3 years.

Retainers 1.28 kg lighter than standard care; 1.70 kg lighter than nonretainers at 3 years

Retainers were on average 1.70 kg lighter than nonretainers and 1.28 kg lighter than those in the standard care arm at 3 years.

Retainers had significantly lower waist circumference than those receiving standard care and nonretainers at 3 years.

Lower levels of anxiety were seen in participants who retained (completed all programme sessions) compared to those receiving standard care. The specific questionnaire used is not confirmed from the excerpts.

Higher quality of life scores were seen in participants who retained compared to those receiving standard care at 3 years.

+925 steps/day in retainers vs standard care

On average, participants who completed the whole programme had a significantly higher step count of 925 steps per day compared to standard care at 3 years.

The Let's Prevent Diabetes programme is a group-based structured education programme for adults with NDH/prediabetes. It comprises a 6-hour initial session, 3-hour annual refresher sessions at 12 and 24 months, and quarterly 15-minute telephone support over 2 years, targeting diet, physical activity, and weight management. The programme matches the 'Lifestyle intervention for prediabetes' class-level intervention in the reference database, which represents comprehensive lifestyle modification programmes for diabetes prevention. The specific programme details (session structure, duration, telephone support) are documented in the study_arms section.

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

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

Extracted 9 outcome signals across the study

ITT analysis was non-significant for the primary outcome, but per-protocol analyses showed strong associations between programme engagement and reduced T2DM incidence. Most secondary outcomes improved in completers. Non-engagers had higher-risk profiles, suggesting selection bias may contribute.

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

↓ Type 2 diabetes risk with full programme attendance (HR 0.12, 95% CI 0.05–0.28)

Study Evidence Depth: High-depth evidence

Full participation in the Let's Prevent Diabetes programme was strongly associated with lower T2DM risk, though the ITT analysis was not significant

A dose-response relationship was observed: greater attendance linked to greater diabetes risk reduction

Non-engagers had higher-risk profiles, highlighting the need for targeted engagement strategies

Gray LJ, Yates T, Troughton J, et al. Engagement, retention, and progression to type 2 diabetes: a retrospective analysis of the cluster-randomised 'Let's Prevent Diabetes' trial. PLOS Med. 2016;13(7):e1002078. doi:10.1371/journal.pmed.1002078

Secondary analysis: ITT primary analysis was non-significant

Selection bias: people who engaged more had healthier baseline characteristics

Low retention: only 29% completed all programme sessions

Post-hoc attendance grouping not randomised

People with prediabetes who actively engaged in a group-based education programme had much lower risk of developing type 2 diabetes, though only 29% completed all sessions.

↓ Weight, HbA1c, and waist circumference in completers vs standard care

↑ Quality of life and daily step count in programme completers

6-h session at baseline followed by 3-h refresher sessions at 12 and 24 mo; 15-min telephone call every 3 mo

Let's Prevent Diabetes programme (intervention)

Standard care

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

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

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

Engagement in a prediabetes education programme is linked to lower type 2 diabetes risk

This study looked at whether attending more sessions of a diabetes prevention programme helped lower type 2 diabetes risk. People who went to all sessions had an 88% lower risk of developing diabetes compared to those receiving standard care. However, fewer than 1 in 3 people attended all sessions.

The main randomised analysis (ITT) did not show a statistically significant benefit—the strong results come from comparing people who chose to attend all sessions against standard care

People who completed all sessions were generally healthier at baseline (younger, leaner, less likely to smoke), which may explain some of the benefit

Most people in the programme did not attend all sessions, so these results apply mainly to motivated participants

The programme was pragmatic and lower-resource than intensive DPP-style programmes tested in other countries

Association between engagement in a group-based prediabetes education programme and type 2 diabetes risk

Adults aged 40–75 (white European) or 25–75 (South Asian) with prediabetes (NDH)

Engagement in a prediabetes education programme is linked to lower type 2 diabetes risk

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