Clinical trial NCT04939766: Impact of the Use of a Closed-loop Insulin Therapy on the Burden of the Diabetes and the Quality of Life
Official title: Impact of the Use of a Closed-loop Insulin Therapy on the Burden of the Diabetes and the Quality of Life in Type 1 Diabetic Patients With Continuous Glucose Monitoring (CGM)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Burden, Dependency
Keywords: Continuous subcutaneous insulin infusion
Diabetes type 1
Closed loop
Lead sponsor: VitalAire
Sponsor class: INDUSTRY
First posted: 2021-06-25
Enrollment: 250
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal cohort study with a 6 months follow-up evaluation evaluating in type 1 diabetic patients under CSII the impact of closed loop use on quality of life and burden using different validated self questionnaires.
Primary purpose: TREATMENT

Brief summary: The use by diabetes patients of real-time Continuous Glucose Monitoring (CGM) system is becoming widespread and has changed diabetic practice. Automated closed-loop (CL) insulin therapy has come of age. This major technological advance is expected to significantly improve the quality of care for adults, adolescents and children with type 1 diabetes.

Questions remain about patients' perception and acceptance on this automatisation of the management of their glycemic variability.

Thus this study is built to evaluate the impact of the activation of the closed-loop on quality of life and burden of their diabetes in patients with type 1 diabetes under CSII.

Detailed description: This cohort study will follow patients with type 1 diabetes undergoing under continuous subcutaneous insulin infusion (CSII) with Continuous Glucose Monitoring (GCM). After inclusion visit, there's a 20 days' period to assess their quality of life and perception of the burden of their diabetes and confirm their eligibility to the closer-loop. During this 20 days' period, patients should complete all the self-questionnaires.

Then, during the 2d visit, the closed-loop will be activated by the diabetologist for a 6 months follow-up including six visits with 3 phone contacts (at week 1, week 2 and week 6) then 2 direct visits at 3 months and 6 months.

The 3 phone contacts are mainly planned, as recommended in French guidelines, to ensure the good use of the device and to detect or prevent any unexpected events.

The 2 visits at 3 and 6 months, are planned to assess the glycemic variability using Continuous Glucose Monitoring data and to collect perception of the patients via the 2 main criteria self questionnaires (Quality of life and burden to be filled-in by patients at 3 and 6 months) and all perception dimensions by all the self questionnaires.

Main results will provide data on the evolution of quality of life and burden of diabetes by comparison between scores at 6 months and baseline, and evolution of glycemic variability.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetic patients undergoing a CSII therapy for at least 6 months and using Tandem t:slim X2 for at least 4 weeks.
* Patient using CGM for 6 months including Dexcon G6 for at least 4 weeks.
* Eligible patient (according to French Society recommendations) for activation of the closed loop
* Informed Patient accepting the computer processing of their medical data.
* Patient correctly completing the 2 main self questionnaires
* Patient with HbA1c below 11%

Exclusion Criteria:

* Pregnancy or Lactation during the study
* Patient with a diabetic retinopathy not controlled by laser
* Patient suffering from a disease or undertaking a treatment altering glucose metabolism

Primary outcomes:
measure: Change in Quality of life following activation of closed loop
timeFrame: Score comparison between Baseline and 6 months after activation of closed loop
measure: Change in burden of diabetes following activation of closed loop
timeFrame: Score comparison between Baseline and 6 months after activation of closed loop
Secondary outcomes:
measure: Perception of patients
timeFrame: Before and 6 months after activation of closed loop
measure: Glycemic variability
timeFrame: Before, 3 months and 6 months after activation of closed loop
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Caen
name: Yves Reznik, MD PHD
role: STUDY_CHAIR
References:
citation: Tubiana-Rufi N, Schaepelynck P, Franc S, Chaillous L, Joubert M, Renard E, Reznik Y, Abettan C, Bismuth E, Beltrand J, Bonnemaison E, Borot S, Charpentier G, Delemer B, Desserprix A, Durain D, Farret A, Filhol N, Guerci B, Guilhem I, Guillot C, Jeandidier N, Lablanche S, Leroy R, Melki V, Munch M, Penfornis A, Picard S, Place J, Riveline JP, Serusclat P, Sola-Gazagnes A, Thivolet C, Hanaire H, Benhamou PY; SFD SFD Paramedical SFE SFEDP AJD FFD FENAREDIAM and CNP-EDN. Practical implementation of automated closed-loop insulin delivery: A French position statement. Diabetes Metab. 2021 May;47(3):101206. doi: 10.1016/j.diabet.2020.10.004. Epub 2020 Nov 2.