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

Quality of Life Clinical Trial

— IMPLIQUE  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04939766
• Other study ID #: 2021-A00005-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: December 2022

Study information

• Verified date: June 2021
• Source: VitalAire
• Contact: Emmanuelle MORRY
• Phone: 0149694515
• Email: emmanuelle.morry[@]vitalaire.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burden, Dependency
• Quality of Life

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VitalAire

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Perception of patients	Different validated self questionnaires on well-being, Fatigue, Anxiety and Depression, Physical activity, Sleep, Fear of hypoglycemia and personality.	Before and 6 months after activation of closed loop
Secondary	Glycemic variability	Collection of symptomatic hypoglycemic and hyperglycemic events. Data from GCM including time in range, time above range, time below range and glycemic variability coefficient.	Before, 3 months and 6 months after activation of closed loop