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

Groupe Hospitalier Pitie-Salpetriere

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Glucose Metabolism Disorders (Including Diabetes Mellitus)

Treatments: Device: Insulin Pump and flash glucose monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03671161

CIC1421-18-15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

19 participants in 1 patient group

Patients with poorly controlled diabetes type 1

Experimental group

Description:

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

Treatment:

Device: Insulin Pump and flash glucose monitoring