- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04939766
Impact of the Use of a Closed-loop Insulin Therapy on the Burden of the Diabetes and the Quality of Life (IMPLIQUE)
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emmanuelle MORRY
- Phone Number: 0149694515
- Email: emmanuelle.morry@vitalaire.fr
Study Contact Backup
- Name: Cecile CABALLOL
- Email: cecile.caballol@vitalaire.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of life following activation of closed loop
Time Frame: Score comparison between Baseline and 6 months after 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
Time Frame: Score comparison between Baseline and 6 months after 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perception of patients
Time Frame: Before and 6 months after activation of closed loop
|
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
|
Glycemic variability
Time Frame: Before, 3 months and 6 months after activation of closed loop
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Yves Reznik, MD PHD, University Hospital, Caen
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A00005-36
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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