Trials / Completed
CompletedNCT03671161
Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Poorly Controlled Diabetes Type 1 Patients
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2017-07-01
- Completion
- 2017-07-01
- First posted
- 2018-09-14
- Last updated
- 2020-05-20
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03671161. Inclusion in this directory is not an endorsement.