Clinical trial NCT03671161: Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Poorly Controlled Diabetes Type 1 Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus)
Diabetes Mellitus, Type 1
Keywords: Diabetes Type 1
Insulin Pump
flash glucose monitoring
hypoglycemia
ketoacidocetosis
DTSQ
HFS
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in HbA1c ≥1%
timeFrame: 6 months
measure: Number of severe hypoglycemia episodes
timeFrame: 6 months
measure: Number of ketoacidosis episodes
timeFrame: 6 months
Secondary outcomes:
measure: Any positive change in DTSQ scale (ΔDTSQM6-DTSQM0>0) (Diabetes Treatment Satisfaction Questionnaire)
timeFrame: 6 months
measure: Any positive change in HFS scale (Hypoglycemia Fear Scale)
timeFrame: 6 months
measure: Number of Hypoglycemia episodes
timeFrame: 6 months
measure: Frequency of hypoglycemia episodes
timeFrame: 6 months
measure: Frequency of severe hypoglycemia episodes
timeFrame: 6 months
measure: Frequency of ketoacidosis episodes
timeFrame: 6 months
measure: Any changes in Weight
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière
Study officials:
References:
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.