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

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

HR 0.42 (95% CI 0.29 to 0.60) p<0.001; 45/379 intervention vs 94/370 control

Cumulative T2D incidence was 57% lower in the intervention group compared with control (45/379 vs 94/370, HR 0.42, 95% CI 0.29-0.60, p<0.001) over mean 3.1 years follow-up.

≥5% weight loss at 1 year: HR 0.35 (95% CI 0.22 to 0.56) p<0.001

Participants with ≥5% weight loss at one year had 65% lower T2D incidence (HR 0.35, 95% CI 0.22-0.56, p<0.001). Maintaining ≥5% weight loss for two and three years further reduced T2D incidence, demonstrating a dose-response relationship between sustained weight loss and diabetes prevention.

The pooled EDIPS intervention applies the Finnish DPS protocol across three European centres, targeting diet, physical activity, and ≥5% weight loss. Matches directly to INT042 'Lifestyle intervention for prediabetes' at the class level.

Positive: 2; Negative: 0; No effect: 0; Mixed: 0

Extracted 2 outcome signals across the study

Primary outcome (T2D incidence) showed highly significant 57% reduction. Secondary analysis of ≥5% weight loss showed even stronger risk reduction (65%). All results consistent with prior evidence from the component trials.

↓ T2D incidence by 57% in lifestyle intervention vs control (HR 0.42, 95% CI 0.29–0.60, p<0.001)

↓ T2D incidence by 65% in those with ≥5% weight loss at 1 year (HR 0.35, 95% CI 0.22–0.56, p<0.001)

Study Evidence Depth: High-depth evidence

Pooled analysis of three European RCTs confirms lifestyle intervention effectively prevents T2D in adults with IGT across diverse settings

≥5% weight loss at one year is a strong predictor of diabetes prevention, and maintaining this loss provides additional benefit

Risk prediction tools (FINDRISC, FPG, HbA1c) can identify high-risk groups but optimal cut-points remain uncertain

Penn L, White M, Lindström J, et al. Importance of weight loss maintenance and risk prediction in the prevention of type 2 diabetes: analysis of European Diabetes Prevention Study RCT. PLoS ONE. 2013;8(2):e57143. doi:10.1371/journal.pone.0057143

Pooled analysis combines trials with some variability in intervention delivery across sites

Weight loss analysis is per-protocol, not ITT — people who lost weight may have differed in other ways

Limited to three European populations — may not generalise to other regions or ethnic groups

A pooled analysis of three European trials confirms that lifestyle intervention reduces type 2 diabetes risk by 57%, and that sustained weight loss of 5% or more is a strong predictor of prevention.

Sustained ≥5% weight loss at 2–3 years associated with further risk reduction

Intensive lifestyle intervention aiming to increase physical activity, modify diet, and promote weight loss ≥5%. Based on Finnish DPS protocol with local adaptations across three European centres.

Intensive lifestyle intervention (EDIPS protocol)

Lifestyle advice control

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

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

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

Intensive lifestyle programme cuts type 2 diabetes risk by 57% in European prediabetes trial

This study combined data from three European trials of lifestyle programmes for people with prediabetes. The lifestyle programme cut diabetes risk by 57% overall, and those who lost 5% or more of their body weight in the first year had a 65% lower risk. Keeping the weight off for longer led to even greater protection.

The pooled analysis combines three trials with similar but not identical protocols — some variation in delivery and setting exists

The weight loss analysis is observational within the RCT — people who achieve weight loss may have other characteristics that contribute to lower risk

The 57% risk reduction is similar to the landmark US DPP (58%) and Finnish DPS (58%) results

Effectiveness of lifestyle intervention and weight loss maintenance for T2D prevention across European EDIPS trials

Intensive lifestyle programme cuts type 2 diabetes risk by 57% in European prediabetes trial

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