Back to resultsFlash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Poorly Controlled Diabetes Type 1 Patients (FREESTYLE)
Primary Purpose
Glucose Metabolism Disorders (Including Diabetes Mellitus), Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Insulin Pump and flash glucose monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Glucose Metabolism Disorders (Including Diabetes Mellitus) focused on measuring Diabetes Type 1, Insulin Pump, flash glucose monitoring, hypoglycemia, ketoacidocetosis, DTSQ, HFS
Eligibility Criteria
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
Sites / Locations
- Groupe Hospitalier Pitié-Salpêtrière
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with poorly controlled diabetes type 1
Arm 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
Outcomes
Primary Outcome Measures
Change in HbA1c ≥1%
Blood samples at baseline and 6 months
Number of severe hypoglycemia episodes
Number of severe hypoglycemia episodes, evaluated by flash glucose monitoring
Number of ketoacidosis episodes
Secondary Outcome Measures
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
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
Number of Hypoglycemia episodes
Number of hypoglycemia episodes, evaluated by Flash glucose monitoring
Frequency of hypoglycemia episodes
Frequency of hypoglycemia episodes, evaluated by Flash glucose monitoring
Frequency of severe hypoglycemia episodes
Frequency of severe hypoglycemia episodes, evaluated by Flash glucose monitoring
Frequency of ketoacidosis episodes
Any changes in Weight
Weight measures at baseline 2 months and 6 months
Full Information
NCT ID
NCT03671161
First Posted
September 7, 2018
Last Updated
May 18, 2020
Sponsor
Groupe Hospitalier Pitie-Salpetriere
1. Study Identification
Unique Protocol Identification Number
NCT03671161
Brief Title
Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Poorly Controlled Diabetes Type 1 Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Groupe Hospitalier Pitie-Salpetriere
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders (Including Diabetes Mellitus), Diabetes Mellitus, Type 1
Keywords
Diabetes Type 1, Insulin Pump, flash glucose monitoring, hypoglycemia, ketoacidocetosis, DTSQ, HFS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
19 patients with type 1 diabetes, HbA1c >9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day.
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with poorly controlled diabetes type 1
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Insulin Pump and flash glucose monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in HbA1c ≥1%
Description
Blood samples at baseline and 6 months
Time Frame
6 months
Title
Number of severe hypoglycemia episodes
Description
Number of severe hypoglycemia episodes, evaluated by flash glucose monitoring
Time Frame
6 months
Title
Number of ketoacidosis episodes
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Any positive change in DTSQ scale (ΔDTSQM6-DTSQM0>0) (Diabetes Treatment Satisfaction Questionnaire)
Description
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
Title
Any positive change in HFS scale (Hypoglycemia Fear Scale)
Description
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
Title
Number of Hypoglycemia episodes
Description
Number of hypoglycemia episodes, evaluated by Flash glucose monitoring
Time Frame
6 months
Title
Frequency of hypoglycemia episodes
Description
Frequency of hypoglycemia episodes, evaluated by Flash glucose monitoring
Time Frame
6 months
Title
Frequency of severe hypoglycemia episodes
Description
Frequency of severe hypoglycemia episodes, evaluated by Flash glucose monitoring
Time Frame
6 months
Title
Frequency of ketoacidosis episodes
Time Frame
6 months
Title
Any changes in Weight
Description
Weight measures at baseline 2 months and 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Groupe Hospitalier Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31265349
Citation
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 with Type 1 Diabetes. Diabetes Technol Ther. 2019 Jul;21(7):409-412. doi: 10.1089/dia.2019.0041.
Results Reference
result
Learn more about this trial
Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Poorly Controlled Diabetes Type 1 Patients
We'll reach out to this number within 24 hrs