Impact of the Use of a Closed-loop Insulin Therapy on the Burden of the Diabetes and the Quality of Life

NCT ID: NCT04939766

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2022-12-31

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.

Conditions

Quality of Life; Burden, Dependency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Type 1 diabetic patients under CSII eligible for closed loop use

Diabetic patients age 13 or above under CSII with continuous glucose monitoring matching eligibility criteria for the use of a closed loop during a 6 months period. During the study, 4 physical appointments with a diabetologist and 3 phone contacts are anticipated.

Group Type: OTHER

Activation of a closed loop device in an insulin pump device with GCM

Intervention Type: DEVICE

After a run-in period of 20 days to co,firm eligibility, the closed loop is activated and patients are followed for 6 months by their diabetologists.

Interventions

Activation of a closed loop device in an insulin pump device with GCM

After a run-in period of 20 days to co,firm eligibility, the closed loop is activated and patients are followed for 6 months by their diabetologists.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VitalAire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yves Reznik, MD PHD

Role: STUDY_CHAIR

University Hospital, Caen

Central Contacts

Emmanuelle MORRY

Role: CONTACT

emmanuelle.morry@vitalaire.fr

0149694515

Cecile CABALLOL

Role: CONTACT

cecile.caballol@vitalaire.fr

References

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.

Reference Type: BACKGROUND

PMID: 33152550 (View on PubMed)

Julla JB, Jacquemier P, Bonnemaison E, Fagherazzi G, Hanaire H, Bellicar Schaepelynck P, Mihaileanu M, Renard E, Reznik Y, Riveline JP. Assessment of the Impact of Subcutaneous Catheter Change on Glucose Control in Patients with Type 1 Diabetes Treated by Insulin Pump in Open- and Closed-Loop Modes. Diabetes Technol Ther. 2024 Jul;26(7):442-448. doi: 10.1089/dia.2023.0568. Epub 2024 Mar 7.

Reference Type: DERIVED

PMID: 38350126 (View on PubMed)

Other Identifiers

2021-A00005-36

Identifier Type: -

Identifier Source: org_study_id