The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study).

International audienceOBJECTIVE: To demonstrate that Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support significantly improves HbA(1c) in poorly controlled type 1 diabetic patients. RESEARCH DESIGN AND METHODS: In a six-month open-label parallel-group, multicenter study, adult patients (n = 180) with type 1 diabetes (>1 year), on a basal-bolus insulin regimen (>6 months), with HbA(1c) ≥ 8%, were randomized to usual quarterly follow-up (G1), home use of a smartphone recommending insulin doses with quarterly visits (G2), or use of the smartphone with short teleconsultations every 2 weeks but no visit until point end (G3). RESULTS: Six-month mean HbA(1c) in G3 (8.41 ± 1.04%) was lower than in G1 (9.10 ± 1.16%; P = 0.0019). G2 displayed intermediate results (8.63 ± 1.07%). The Diabeo system gave a 0.91% (0.60; 1.21) improvement in HbA(1c) over controls and a 0.67% (0.35; 0.99) reduction when used without teleconsultation. There was no difference in the frequency of hypoglycemic episodes or in medical time spent for hospital or telephone consultations. However, patients in G1 and G2 spent nearly 5 h more than G3 patients attending hospital visits. CONCLUSIONS: The Diabeo system gives a substantial improvement to metabolic control in chronic, poorly controlled type 1 diabetic patients without requiring more medical time and at a lower overall cost for the patient than usual care

Reduction of clinically important low glucose excursions with a long‐term implantable continuous glucose monitoring ( CGM ) system in adults with type 1 diabetes prone to hypoglycemia. France Adoption randomized clinical trial

International audienceAim: This trial assessed the outcomes on glucose control of the implantable Eversense real-time continuous glucose monitoring (CGM) system compared to self-monitoring of blood glucose or intermittently scanned CGM in patients with type 1 or type 2 diabetes (T1D or T2D).Patients and methods: This was a randomized (2:1), prospective, national, multicenter study. All participants, aged >18, on multiple daily insulin injections or insulin pump had a sensor inserted, activated only in the enabled group. Included patients had T1D or T2D with an HbA1c level >8% (cohort 1) or T1D with a time below range 1.5 hour/day during the previous 28 days (cohort 2). The primary outcomes were the HbA1c change at D180 (cohort 1) or the change in TBR180 ) was observed. In cohort 2, the mean adjusted difference in TBR<54 was -1.6% [-3.1; -0.1], p=0.039 during D90-D120 and remained at -2.6%, [-4.5; -0.6], p=0.011 during D150-D180 (pre-specified secondary outcome). There was no safety issue.Conclusion: This study shows that the Eversense CGM system can significantly decrease TBR<54 in patients with T1D prone to hypoglycemia