Diabeloop DBLG1 Closed-Loop System Enables Patients With Type 1 Diabetes to Significantly Improve Their Glycemic Control in Real-Life Situations Without Serious Adverse Events: 6-Month Follow-up

2021 ◽  
Author(s):  
Coralie Amadou ◽  
Sylvia Franc ◽  
Pierre-Yves Benhamou ◽  
Sandrine Lablanche ◽  
Erik Huneker ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Adverse Events ◽  
Closed Loop ◽  
Artificial Pancreas ◽  
Real Life ◽  
Serious Adverse Events ◽  
Life Conditions ◽  
Time In Range

<b>OBJECTIVE </b> <p>To analyze safety and efficacy of the DBLG1 hybrid closed-loop artificial pancreas system in patients with Type 1 Diabetes in real life conditions. </p> <p> </p> <p><b>METHODS</b></p> <p>Following a one-week run-in period with usual pump, 25 patients were provided with the commercial DBLG1 system. We present the results of Time-in-Range and HbA1c over a 6-month period.</p> <p><b> </b></p> <p><b>RESULTS</b></p> <p>The mean (SD;range) age of patients was 43 years (13.8; 25-72). At baseline, mean HbA1c and TIR 70-180mg/dL were respectively 7.9% (0.93; 5.6- 8.5) [63mmol/mol (10; 38-69)] and 53% (16.4;21-85). One patient stopped using the system after 2 months. At 6-month, mean HbA1c decreased to 7.1% [54mmol/mol] (p<0.001) and TIR 70-180mg/dL increased to 69.7% (p<0.0001). TIR<70mg/dL decreased from 2.4 to 1.3% (p=0.03). TIR<54mg/dL decreased from 0.32 to 0.24% (p=0.42). No serious adverse event was reported during the study. </p> <p> </p> <p><b>CONCLUSION</b></p> <p>The DBLG1 System confirms its ability to significantly improve glycemic control in real life conditions, without serious adverse events. </p>

scholarly journals Diabeloop DBLG1 Closed-Loop System Enables Patients With Type 1 Diabetes to Significantly Improve Their Glycemic Control in Real-Life Situations Without Serious Adverse Events: 6-Month Follow-up

2021 ◽  
Author(s):  
Coralie Amadou ◽  
Sylvia Franc ◽  
Pierre-Yves Benhamou ◽  
Sandrine Lablanche ◽  
Erik Huneker ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Adverse Events ◽  
Closed Loop ◽  
Artificial Pancreas ◽  
Real Life ◽  
Serious Adverse Events ◽  
Life Conditions ◽  
Time In Range

<b>OBJECTIVE </b> <p>To analyze safety and efficacy of the DBLG1 hybrid closed-loop artificial pancreas system in patients with Type 1 Diabetes in real life conditions. </p> <p> </p> <p><b>METHODS</b></p> <p>Following a one-week run-in period with usual pump, 25 patients were provided with the commercial DBLG1 system. We present the results of Time-in-Range and HbA1c over a 6-month period.</p> <p><b> </b></p> <p><b>RESULTS</b></p> <p>The mean (SD;range) age of patients was 43 years (13.8; 25-72). At baseline, mean HbA1c and TIR 70-180mg/dL were respectively 7.9% (0.93; 5.6- 8.5) [63mmol/mol (10; 38-69)] and 53% (16.4;21-85). One patient stopped using the system after 2 months. At 6-month, mean HbA1c decreased to 7.1% [54mmol/mol] (p<0.001) and TIR 70-180mg/dL increased to 69.7% (p<0.0001). TIR<70mg/dL decreased from 2.4 to 1.3% (p=0.03). TIR<54mg/dL decreased from 0.32 to 0.24% (p=0.42). No serious adverse event was reported during the study. </p> <p> </p> <p><b>CONCLUSION</b></p> <p>The DBLG1 System confirms its ability to significantly improve glycemic control in real life conditions, without serious adverse events. </p>

1066-P: Improvement in Time-in-Range (TIR) with Real-Life Use of Hybrid Closed-Loop System in Patients with Type 1 Diabetes (T1D)

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 1066-P
Author(s):  
HALIS K. AKTURK ◽  
DOMINIQUE A. GIORDANO ◽  
HAL JOSEPH ◽  
SATISH K. GARG ◽  
JANET K. SNELL-BERGEON
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Real Life ◽  
Loop System ◽  
Closed Loop System ◽  
Time In Range

scholarly journals Randomized Cross-Over Study Comparing Two Infusion Sets for CSII in Daily Life

2016 ◽  
Vol 11 (2) ◽  
pp. 253-259 ◽  
Author(s):  
Guido Freckmann ◽  
Stephan Arndt ◽  
Albrecht Fießelmann ◽  
Gerhard Klausmann ◽  
Kristina Pralle ◽  
...  
Keyword(s):  
Adverse Events ◽  
Insulin Infusion ◽  
Insulin Pump ◽  
Real Life ◽  
Open Label ◽  
Serious Adverse Events ◽  
Life Conditions ◽  
Essential Components ◽  
The Mean

Background: Continuous subcutaneous insulin infusion (CSII) therapy is a valuable option especially for people with type 1 diabetes. Although insulin infusion sets (IIS) are essential components of most insulin pump systems, only few studies have been conducted on their performance and safety. In this study 2 IIS with soft cannulas were compared. Methods: In an open-label, randomized, crossover, multicenter 8-week study 80 type 1 diabetic subjects on CSII (20-74 years, mean 46.5 ± 12.9 years, 58.8% male) were enrolled to evaluate the use of 2 IIS. The Accu-Chek® FlexLink Plus (FL Plus) and the Accu-Chek® FlexLink infusion set (FL) were used 4 weeks each under real-life conditions at home. All patients had to record details about every IIS change in a diary. Insertion-related pain was assessed by means of a visual analogue scale (VAS). Results: The mean pain noted during insertion was similar for both IIS (VAS 6.1 ± 6.4 mm for the FL Plus and 5.8 ± 6.3 mm for the FL, P = .92). 20.0% of the 895 IIS changes with FL Plus and 16.0% of the 854 with FL were unplanned. During the 4243 patient days of the study, 13 patients had adverse events. Among these, 2 serious adverse events occurred. Both serious events and 1 nonserious adverse event were considered as related to the IIS. Of the patients, 18.7% had kinked cannulas. Most patients were satisfied with both IIS. Conclusion: Both IIS are safe and effective. The 2 IIS did not differ from each other with respect to pain observed during insertion.

scholarly journals Free-living use of artificial pancreas for children with type 1 diabetes: systematic review

2018 ◽  
Vol 21 (3) ◽  
pp. 206-216
Author(s):  
Klemen Dovc ◽  
Gül Yeşiltepe Mutlu ◽  
Yury I. Philippov ◽  
Dmitry N. Laptev ◽  
Evgenia M. Patrakeeva ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 1 Diabetes ◽  
Control System ◽  
Glucose Control ◽  
Closed Loop ◽  
Artificial Pancreas ◽  
Hospital Environment ◽  
Time In Range ◽  
Randomized Control

BACKGRAUND: A closed-loop glucose control system or artificial pancreas consists of three components a Continuous Glucose Monitor (CGM), infusion pumps to deliver hormone(s) and a sophisticated dosing algorithm to control hormone delivery. In the past years, numerous studies with closed-loop system devices were conducted with gradual shift to out-of-hospital environment and with lengthening study duration. AIMS: To compare efficacy and safety of closed-loop insulin pump use in children with type 1 diabetes mellitus in compare with conventional insulin treatment (continuous subcutaneous insulin infusion (CSII) with our without CGM) based on randomized control trials data (RCT). METHODS: In the systematic review we have include 28 randomized controlled trials results indexed in PubMed, Medline databases published till 15 June 2017. The efficacy on metabolic control in this study evaluated by the proportion of time within target range (preferably 70 to 180 mg/dl if reported) and mean (median) glucose based on sensor measurements, and the safety evaluated by time in hypoglycemia (below 70 mg/dl if reported). RESULTS: Increased time in range in the night period was observed in all RCT. Only 3 RCT showed decrease of the time in range within 24 h evaluation period. In one RCT the significant positive differences have been shown in the time in range for dual hormone closed-loop glucose control system in compare with insulin-only artificial pancreas. Mean glycaemia and glucose variability changes were not in the same manner in different RCT, both in the night only and in 24 h estimation period. Night hypoglycemia duration decreased in most RCT with closed-loop control in compare with CSII, and increased only in 2 RCT. When all-day estimation period the time in hypoglycemia changed not in the same manner in different RCT. Valuable methodology differences of the glycaemic control estimation within observed RCT brought significant complications in the data analysis and made impossible the results quantitative estimation to prepare a metaanalysis. CONCLUSIONS: Much work has been done to develop effective and safe artificial pancreas, but not all RCTs confirmed advantages of closed-loop glucose control in compare with CSII in children and adolescents in real life. More research with prospective randomized control design required to prove benefits of closed-loop glucose control. Further RCTs should have an uniform methodology for glycemic control assessment and long duration that will allow to use cumulative measures in a closed-loop efficacy estimation (HbA1c).

scholarly journals Lower Daily Carbohydrate Intake is associated with Improved Glycemic Control in Adults with Type 1 Diabetes using a Hybrid Closed-Loop System

2020 ◽  
Author(s):  
Vera Lehmann ◽  
Thomas Zueger ◽  
Anna Zeder ◽  
Sam Scott ◽  
Lia Bally ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Closed Loop ◽  
Glucose Monitoring ◽  
Closed Loop System ◽  
Female Age ◽  
Time In Range ◽  
Design And Methods

<i>Objective</i> <p>To assess the association between daily carbohydrate (CHO) intake and glycemic control in adult hybrid closed-loop (HCL) users with type 1 diabetes mellitus (T1D).</p> <p><i>Research Design and Methods</i></p> <p>Mean individual daily CHO intake (MIDC) and deviation from MIDC (rMIDC; ≤80% low; 81-120% medium, >120% high CHO consumption) were compared with parameters of glycemic control assessed by continuous glucose monitoring (CGM). </p> <p><i>Results</i></p> <p>Records from 36 patients (26 male, 10 female; age 36.9±13.5y; HbA<sub>1c</sub> 7.1±0.9% [54±10mmol/mol]) provided 810 days of data (22.5±6.7 days per patient). Time in range (70-180mg/dL) for low, medium, and high CHO consumption was 77.4±15.4%, 75.2±16.7% and 70.4±17.8%, respectively (<i>p</i><0.001). Time above range (>180mg/dL) was 20.1±14.7%, 22.0±16.9% and 27.2±18.4%, respectively (<i>p</i><0.001). There was no between-group difference for time in hypoglycemia (<70mg/dL; <i>p</i>=0.50).</p> <p><i>Conclusions</i></p> Daily CHO intake was inversely associated with glycemic control in adults with T1D using a HCL system. Lower CHO intake may be a strategy to optimize glucose control in HCL users.

scholarly journals Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial

2019 ◽  
Vol 1 (1) ◽  
pp. e17-e25 ◽  
Author(s):  
Pierre-Yves Benhamou ◽  
Sylvia Franc ◽  
Yves Reznik ◽  
Charles Thivolet ◽  
Pauline Schaepelynck ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Crossover Trial ◽  
Real Life ◽  
Insulin Delivery ◽  
Open Label ◽  
Life Conditions ◽  
Randomised Controlled

scholarly journals Lower Daily Carbohydrate Intake is associated with Improved Glycemic Control in Adults with Type 1 Diabetes using a Hybrid Closed-Loop System

2020 ◽  
Author(s):  
Vera Lehmann ◽  
Thomas Zueger ◽  
Anna Zeder ◽  
Sam Scott ◽  
Lia Bally ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Closed Loop ◽  
Glucose Monitoring ◽  
Closed Loop System ◽  
Female Age ◽  
Time In Range ◽  
Design And Methods

<i>Objective</i> <p>To assess the association between daily carbohydrate (CHO) intake and glycemic control in adult hybrid closed-loop (HCL) users with type 1 diabetes mellitus (T1D).</p> <p><i>Research Design and Methods</i></p> <p>Mean individual daily CHO intake (MIDC) and deviation from MIDC (rMIDC; ≤80% low; 81-120% medium, >120% high CHO consumption) were compared with parameters of glycemic control assessed by continuous glucose monitoring (CGM). </p> <p><i>Results</i></p> <p>Records from 36 patients (26 male, 10 female; age 36.9±13.5y; HbA<sub>1c</sub> 7.1±0.9% [54±10mmol/mol]) provided 810 days of data (22.5±6.7 days per patient). Time in range (70-180mg/dL) for low, medium, and high CHO consumption was 77.4±15.4%, 75.2±16.7% and 70.4±17.8%, respectively (<i>p</i><0.001). Time above range (>180mg/dL) was 20.1±14.7%, 22.0±16.9% and 27.2±18.4%, respectively (<i>p</i><0.001). There was no between-group difference for time in hypoglycemia (<70mg/dL; <i>p</i>=0.50).</p> <p><i>Conclusions</i></p> Daily CHO intake was inversely associated with glycemic control in adults with T1D using a HCL system. Lower CHO intake may be a strategy to optimize glucose control in HCL users.

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