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

Groupe Hospitalier Pitie-Salpetriere19 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Enrollment

Conditions

Glucose Metabolism Disorders (Including Diabetes Mellitus)Diabetes Mellitus, Type 1

Interventions

Insulin Pump and flash glucose monitoringDEVICE

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 start a FGM system (Free Style Libre®) during 6 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Groupe Hospitalier Pitié-Salpêtrière

Paris, France

Outcomes

Primary Outcomes

Change in HbA1c ≥1%

Blood samples at baseline and 6 months

Time frame: 6 months

Number of severe hypoglycemia episodes

Number of severe hypoglycemia episodes, evaluated by flash glucose monitoring

Time frame: 6 months

Number of ketoacidosis episodes

Time frame: 6 months

Secondary Outcomes

Any positive change in DTSQ scale (ΔDTSQM6-DTSQM0>0) (Diabetes Treatment Satisfaction Questionnaire)

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

Time frame: 6 months

Any positive change in HFS scale (Hypoglycemia Fear Scale)

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

Time frame: 6 months

Number of Hypoglycemia episodes

Number of hypoglycemia episodes, evaluated by Flash glucose monitoring

Time frame: 6 months

Frequency of hypoglycemia episodes

Frequency of hypoglycemia episodes, evaluated by Flash glucose monitoring

Time frame: 6 months

Frequency of severe hypoglycemia episodes

Data from ClinicalTrials.gov

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