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

Diabetes Mellitus, Type 1 Clinical Trial

— FREESTYLE  

Official title:

Combination of Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 1 Diabetes and Poor Glycemic Control Related to Very Few Self-blood Glucose Measurements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671161
• Other study ID #: CIC1421-18-15
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: May 2020
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Glucose Metabolism Disorders
• Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Metabolic Diseases

Intervention

Device:
• 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. Patients will be switched to insulin pump and start a FGM system (Free Style Libre®) during 6 months.

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

References & Publications (1)

Halbron M, Bourron O, Andreelli F, Ciangura C, Jacqueminet S, Popelier M, Bosquet F, Rouanet S, Amouyal C, Hartemann A. Insulin Pump Combined with Flash Glucose Monitoring: A Therapeutic Option to Improve Glycemic Control in Severely Nonadherent Patients — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c =1%	Blood samples at baseline and 6 months	6 months
Primary	Number of severe hypoglycemia episodes	Number of severe hypoglycemia episodes, evaluated by flash glucose monitoring	6 months
Primary	Number of ketoacidosis episodes		6 months
Secondary	Any positive change in DTSQ scale (?DTSQM6-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	6 months
Secondary	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	6 months
Secondary	Number of Hypoglycemia episodes	Number of hypoglycemia episodes, evaluated by Flash glucose monitoring	6 months
Secondary	Frequency of hypoglycemia episodes	Frequency of hypoglycemia episodes, evaluated by Flash glucose monitoring	6 months
Secondary	Frequency of severe hypoglycemia episodes	Frequency of severe hypoglycemia episodes, evaluated by Flash glucose monitoring	6 months
Secondary	Frequency of ketoacidosis episodes		6 months
Secondary	Any changes in Weight	Weight measures at baseline 2 months and 6 months	6 months