Sylvia Franc, France

Centre Hospitalier Sud-Francilien Diabetes and Endocrinology

Presenter of 3 Presentations

 Conference Calendar

DIABELOOP CLOSED LOOP SYSTEM ALLOWS PATIENTS WITH DIABETES TYPE 1 (DT1) TO PRACTICE PHYSICAL ACTIVITY (PA) WITHOUT INCREASING HYPOGLYCAEMIC RISK

Session Name
ARTIFICIAL PANCREAS
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:39 - 09:40
Presenter
Authors

Abstract

Background and Aims

Is the closed-loop system DBLG1 able to reduce hypoglycaemic risk in case of physical activity (PA) in patients with T1D ?

Methods

We conducted a 3 months crossover trial where patients were using either a hybrid monohormonal system (CellNovo® or Kaleido® pump and Dexcom G5® sensor) using MPC-based algorithm and centralized remote monitoring, or an open loop. Patients were encouraged to practice PA, but it was recommended to announce in advance to the system, the occurrence, intensity and duration of PA.

Results

68 patients (27 men, age 47.2±13.4 years, HbA1c 7.6±0.9%, were included, and 63 were analyzed (mITT). The median number of PA events per patient during the study was 10, median duration 60 mn, intensity light (40%), medium (42%) intense (19%). Time in range (TIR) (70-180 mg/dl) was similar with (68.2 ± 1.1%) or without (69.1 ± 1.1%) PA, as was TIR<70 mg/dl during the day (2.3 ± 0.2% v 2.4 ± 0.2%) or the night (1.2 ± 0.2% v 1.6 ± 0.2%). TIR<70 mg/dl was 1.9, 2.1, 1.9 and 2.0% following PA duration of <30mn, 30 to 60, 60 to 90 or >90 mn, and 1.6, 2.2 or 2.2% following light, medium or intense PA. TIR<70 mg/dl was 2.2, 2.3 and 1.7% with announcement <30, 30 to 60 and > 60 mn before PA and 2.3% with none.

Conclusions

The Diabeloop’s DBLG1 System is able to maintain good glycemic control even in the case of PA practice. Duration, intensity or PA announcement demonstrated modest impact.

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EFFICACY OF THE DIABEO SYSTEM FOR THE PRAGMATIC TELEMEDICINE MANAGEMENT OF DIABETIC PATIENTS POORLY CONTROLLED WITH A BASAL-BOLUS INSULIN REGIMEN

Session Name
INFORMATICS IN THE SERVICE OF MEDICINE; TELEMEDICINE, SOFTWARE AND OTHER TECHNOLOGIES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:43 - 09:44
Presenter
Authors

Abstract

Background and Aims

The DIABEO system is a telemedicine solution for real time monitoring of insulin treatment. Many people downloading a mobile health app in real-life stop using it after a single utilization. Therefore, we conducted a large pragmatic study to investigate the usage and efficacy of DIABEO in conditions close to real-life (the TELESAGE study).

Methods

Pragmatic, multicenter, randomized, open-label, three parallel-arms study in type 1 and type 2 diabetic patients poorly controlled with a basal-bolus insulin regimen (ClinicalTrials.gov NCT02287532). TELESAGE compared: (i) a control group (arm 1: standard care) versus the software alone (arm 2) and versus the software + telemonitoring by trained nurses (arm 3). The primary outcome evaluated HbA1c reduction after 12-month follow-up.

Results

Six-hundred-sixty-five (665) patients were included in the study. Baseline characteristics of patients were comparable among the three study groups. As expected, 25.1% participants in arm 2 and 37.6% in arm 3 used the DIABEO (± telemonitoring) system one or more times per day (DIABEO users). DIABEO users showed a significant and meaningful mean HbA1c reduction versus standard care: -0.41% for arm 2 (P = 0.001) and -0.51% for arm 3 (P ≤0.001) without significant differences in hypoglycemic incidence. In the overall population (ITT) HbA1 reduction was comparable between arms.

Conclusions

Under pragmatic conditions, the effectiveness of DIABEO in reducing HbA1c levels in poorly controlled patients depended greatly on the frequency of its use. Significant HbA1c reductions can be obtained by using DIABEO at least once a day.

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DIABELOOP CLOSED LOOP SYSTEM ALLOWS PATIENTS WITH DIABETES TYPE 1 (T1D) TO LARGELY IMPROVE THEIR GLYCEMIC CONTROL IN REAL LIFE SITUATION, WITHOUT SERIOUS ADVERSE EVENTS.

Session Name
ORAL PRESENTATION SESSION 07
Session Type
ORAL PRESENTATION SESSION
Date
22.02.2020, Saturday
Session Time
08:30 - 10:00
Channel
London
Lecture Time
09:30 - 09:40
Presenter
Authors

Abstract

Background and Aims

Previous trials demonstrated a 8.6% per protocol (PP) improvement with the single hormone closed-loop system Diabeloop’s DBLG1 (2017, with Cellnovo pump), then a 14.0% PP improvement (2018 with the Kaleido pump). The objective of the present study was to evaluate the efficacy and safety of the closed-loop system DBLG1 with an improved algorithm and the Kaleido pump, in patients with type 1 diabetes (T1D) in real life situation.

Methods

25 non selected T1D patients in Corbeil and Grenoble diabetes centers, after a 2-week run-in period with G6 sensor and usual pump, were provided with the commercial setting of DBLG1 System with an improved algorithm. They were taught to manage it , during a day-hospitalization, and were checked during a visit, the day after. There was no structured remote monitoring.

Results

After 20 weeks follow-up, compared to run-in period, time in range (TIR) 70-180 mg/dl, improved by 17.1% (53.7% v 70.8%), TIR 50 – 70 mg/dl was halved (2.38% v 1.20%). TIR<50 mg/dl was very low (0.15% v 0.15%), TIR> 250 mg/dl decreased by 2/3 (17.7% v 7.3%). Mean blood glucose decreased from 179.4 mg/dl to 157.5 mg/dl. Satisfaction of patients was great, there was no adverse events due to the algorithm, and the only complaint was about frequent system disconnection. Nevertheless, closed loop was in functional mode for 88% of time during the 20 average weeks of the survey.

Conclusions

The DBLG1 System is able to largely improve glycemic control in real life situation, without serious adverse events.

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