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

NCT04939766 | Unknown DMC

• 1 other identifier: 2021-A00005-36
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Quality of Life; Burden, Dependency

Keywords

Continuous subcutaneous insulin infusion; Diabetes type 1; Closed loop

Outcome Measures

Primary Outcomes (2)

• Change in Quality of life following activation of closed loop

  Validated self questionnaire : Audit of Diabetes dependant quality of life (ADQQoL) with 19 items Lower scores reflect worsening quality of life

  Score comparison between Baseline and 6 months after activation of closed loop

• Change in burden of diabetes following activation of closed loop

  Validated self questionnaire : Problem Areas s in Diabetes (PAID) with 20 items. Higher scores reflect greater emotional distress.

  Score comparison between Baseline and 6 months after activation of closed loop

Secondary Outcomes (2)

• Perception of patients

  Before and 6 months after activation of closed loop

• Glycemic variability

  Before, 3 months and 6 months after activation of closed loop

Study Arms (1)

Type 1 diabetic patients under CSII eligible for closed loop use

OTHER

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.

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

Interventions

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

Type 1 diabetic patients under CSII eligible for closed loop use

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• VitalAire: lead

Related Publications (2)

• 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.

  PMID: 33152550 BACKGROUND

• 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.

  PMID: 38350126 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yves Reznik, MD PHD

  University Hospital, Caen

  STUDY CHAIR

Central Study Contacts

Emmanuelle MORRY

CONTACT

0149694515; emmanuelle.morry@vitalaire.fr

Cecile CABALLOL

CONTACT

cecile.caballol@vitalaire.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 25, 2021
• Study Start: June 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share