OBJECTIVELifestyle interventions are the foundation of treatment in newly diagnosed type 2 diabetes. However, their therapeutic potential in advanced disease stages is unknown. We evaluated the efficacy of the Telemedical Lifestyle intervention Program (TeLiPro) in improving metabolic control in advanced-stage type 2 diabetes. RESEARCH DESIGN AND METHODSIn this single-blind, active comparator, intervention study, patients with type 2 diabetes (with glycated hemoglobin [HbA 1c ] ‡7.5% [58.5 mmol/mol]), and BMI ‡27 kg/m 2 and on ‡2 antidiabetes medications) were recruited in Germany and randomized 1:1 using an electronically generated random list and sealed envelopes into two parallel groups. The data analyst was blinded after assignment. The control group (n = 100) got weighing scales and step counters and remained in routine care. The TeLiPro group (n = 102) additionally received telemedical coaching including medicalmental motivation, a formula diet, and self-monitored blood glucose for 12 weeks. The primary end point was the estimated treatment difference in HbA 1c reduction after 12 weeks. All available values per patient (n = 202) were analyzed. Analyses were also performed at 26 and 52 weeks of follow-up. RESULTSHbA 1c reduction was significantly higher in the TeLiPro group (mean 6 SD 21.1 6 1.2% vs. 20.2 6 0.8%; P < 0.0001). The estimated treatment difference in the fully adjusted model was 0.8% (95% CI 1.1; 0.5) (P < 0.0001). Treatment superiority of TeLiPro was maintained during follow-up (week 26: 0.6% [95% CI 1.0; 0.3], P = 0.0001; week 52: 0.6% [0.9; 0.2], P < 0.001). The same applies for secondary outcomes: weight (TeLiPro 26.2 6 4.6 kg vs. control 21.0 6 3.4 kg), BMI (22.1 6 1.5 kg/m 2 vs. 20.3 6 1.1 kg/m 2 ), systolic blood pressure (25.7 6 15.3 mmHg vs. 21.6 6 13.8 mmHg), 10-year cardiovascular disease risk, antidiabetes medication, and quality of life and eating behavior (P < 0.01 for all). The effects were maintained longterm. No adverse events were reported. CONCLUSIONSIn advanced-stage type 2 diabetes, TeLiPro can improve glycemic control and may offer new options to avoid pharmacological intensification.

Background Formula diets can improve glycemic control or can even induce remission in type 2 diabetes. We hypothesized that especially an individualized intense meal replacement by a low-carbohydrate formula diet with accompanied self-monitoring of blood glucose (SMBG) contributes to long-term improvements in HbA1c, weight, and cardiometabolic risk factors in poorly controlled type 2 diabetes. Methods Type 2 diabetes patients were randomized into either a moderate group (M-group) with two meal replacements/day (n = 160) or a stringent group (S-group) with three meal replacements/day (n = 149) during the first week of intervention (1300–1500 kcal/day). Subsequently, both groups reintroduced a low-carbohydrate lunch based on individual adaption due to SMBG in weeks 2–4. After week 4, breakfast was reintroduced until week 12. During the follow-up period, all of the participants were asked to continue replacing one meal per day until the 52-weeks follow-up. Additionally, an observational control group (n = 100) remained in routine care. Parameters were compared at baseline, after 12 and 52 weeks within and between all of the groups. Results 321 participants (83%) completed the acute meal replacement phase after 12 weeks and 279 participants (72%) the whole intervention after 52 weeks. Both intervention groups achieved improvements in HbA1c, fasting blood glucose, blood pressure, and weight (all p < 0.001) within 12 weeks. However, these results were not significantly different between both of the intervention groups. The estimated treatment difference in HbA1c reduction was (mean (95% confidence interval [CI]) -0.10% with 95% CI [−0.40; 0.21] also (p > 0.05) (S-group vs. M-group) not statistically different after 12 weeks. However, only the S-group showed a clinically relevant improvement in HbA1c of −0.81% [−1.06; −0.55] (p < 0.001) after 52 weeks of follow-up, whereas HbA1c was not statistically different between the M- and control group. Conclusion Individualized meal replacement with SMBG demonstrated beneficial effects on HbA1c and cardiometabolic parameters in type 2 diabetes. Furthermore, the initiation of a weight loss program with one week of full meal replacement (three meals per day) resulted in a clinically relevant long-term HbA1c reduction, as compared to an observational control group that had standard care.

Energy-restricted PRMR was effective in reducing insulin requirement of type 2 diabetes patients with intensified insulin therapy accompanied by a reduction of HbA1c, weight and other cardiometabolic risk factors. With the continuous use of PRMR, glycaemic control might be improved in the long term.

Medium and dark roast coffee blends exert small but possibly relevant different cardiometabolic effects. Further studies of health outcomes in relation to coffee constituents seem warranted.

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