Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Poorly Controlled Diabetes Type 1 Patients

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1; Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Interventions: Device: Insulin Pump and flash glucose monitoring

• Registration Number: NCT03671161
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief Summary

Patients with diabetes type 1 with poor glycemic control will be switched to insulin pump and FGM system (Flash Glucose Monitoring) during 6 months, correlated to the hypothesis that they could benefit from this intervention by being reengaged in diabetes self-management.

Detailed Description

This is a non-controlled proof of concept prospective pilot study in adults with type 1 diabetes, HbA1c \>9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day. Patients will be switched to insulin pump and started a FGM system (Free Style Libre®) during 6 months, hoping this intervention can reengage patients in self-management, reduce HbA1c without increasing the risk of ketoacidocetosis (DKA) and severe hypoglycemia (SH), and keep the DTSQ (Diabetes Treatment Satisfaction Questionnaire) and HFS (Hypoglycemia Fear Scale) at good levels.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-07-01
• Study Completion: 2017-07-01
• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-14
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• adults with type 1 diabetes, aged between 18 and 55, HbA1c >9% (75 mmol/mol), multi daily insulin injections (MDI) treatment, maximum 2 SMBG /day

Exclusion Criteria

• diabetes with less than 1 year duration, severe active retinopathy requiring laser therapy, severe psychiatric illness, pregnancy, inability to communicate in French, concomitant severe active disease, patients already using a FGM or a CGM

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with poorly controlled diabetes type 1	Insulin Pump and flash glucose monitoring	Adults with type 1 diabetes, HbA1c \>9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day swithced to Insulin Pump and flash glucose monitoring

Primary Outcome Measures

Name	Time	Method
Change in HbA1c ≥1%	6 months	Blood samples at baseline and 6 months
Number of ketoacidosis episodes	6 months
Number of severe hypoglycemia episodes	6 months	Number of severe hypoglycemia episodes, evaluated by flash glucose monitoring

Secondary Outcome Measures

Name	Time	Method
Frequency of severe hypoglycemia episodes	6 months	Frequency of severe hypoglycemia episodes, evaluated by Flash glucose monitoring
Frequency of ketoacidosis episodes	6 months
Any changes in Weight	6 months	Weight measures at baseline 2 months and 6 months
Any positive change in DTSQ scale (ΔDTSQM6-DTSQM0>0) (Diabetes Treatment Satisfaction Questionnaire)	6 months	Filling questionnaires at baseline and 6 months. DTSQ (Diabetes treatment questionnaire) includes 8 items, each score from 0 to 6 with a higher score indicating better outcome
Number of Hypoglycemia episodes	6 months	Number of hypoglycemia episodes, evaluated by Flash glucose monitoring
Any positive change in HFS scale (Hypoglycemia Fear Scale)	6 months	Filling questionnaires at baseline and 6 months. HFS (Hypoglycemia fear scale) assesses participant's fear of hypoglycemia both overall and separately for behavior (10 items) and worry (17 items), both items scoring from 1 to 5, with lower score indicating better outcome
Frequency of hypoglycemia episodes	6 months	Frequency of hypoglycemia episodes, evaluated by Flash glucose monitoring

Trial Locations

Locations (1)

Groupe Hospitalier Pitié-Salpêtrière; 🇫🇷 Paris, France