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.
A total of 200 patients with peripheral arterial disease (PAD) were randomized to home-based exercise consisting of on-site sessions for the first month, active exercise, and coaching (99 patients) vs usual care (101 patients) for 9 months. The mean change in walking distance was better in the usual care group than in the exercise group. Conclusion:A home-based exercise program consisting of a wearable activity monitor and telephone coaching did not improve walking performance at 9-month follow-up. These results do not support home-based exercise program of wearable devices and telephone counseling without periodic on-site medical center visits to improve walking performance in patients with PAD.Commentary: Clinical practice guidelines recommend either supervised treadmill exercise (class IA recommendation) or home-based walking exercise (class IIA recommendation) as first-line therapy to improve walking in patients with lower extremity PAD. But importantly, both programs required frequent visits to the medical center. But, how often should these visits be required? In this randomized study, the exercise group received four weekly medical center visits during the first month, followed by 8 months of a wearable activity monitor and telephone coaching. The authors suggest increased frequency of periodic on-site visits might have yielded improvedresults. I assume that they mean that if the subjects had visited the medical center three or four times a week instead of once a week, or if they continued to visit the medical center for the full 9-month trial, the exercise program would have resulted in improved walking distances. The study emphasizes that simply telling patients to walk more or involving them in a less than strenuous walking program to improve claudication will not do much good. The problem is that not many vascular surgeons have access to rigorous exercise programs to treat claudication. Until that happens, and until reimbursements for such exercise programs become widespread, the only realistic noninterventional options to treat disabling claudication due to PAD are cilostazol and smoking cessation programs.
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