Diabetes Mellitus, Type 1, Glucose Metabolism Disorders (Including Diabetes Mellitus)
Conditions
Keywords
Diabetes Type 1, Insulin Pump, flash glucose monitoring, hypoglycemia, ketoacidocetosis, DTSQ, HFS
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.
Interventions
DEVICEInsulin 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.
Sponsors
Groupe Hospitalier Pitie-Salpetriere
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c ≥1% | 6 months | Blood samples at baseline and 6 months |
| Number of severe hypoglycemia episodes | 6 months | Number of severe hypoglycemia episodes, evaluated by flash glucose monitoring |
| Number of ketoacidosis episodes | 6 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hypoglycemia episodes | 6 months | Number of hypoglycemia episodes, evaluated by Flash glucose monitoring |
| Frequency of hypoglycemia episodes | 6 months | Frequency of hypoglycemia episodes, evaluated by Flash glucose monitoring |
| Any changes in Weight | 6 months | Weight measures at baseline 2 months and 6 months |
| Frequency of ketoacidosis episodes | 6 months | — |
| Frequency of severe hypoglycemia episodes | 6 months | Frequency of severe hypoglycemia episodes, evaluated by Flash glucose monitoring |
| Any positive change in DTSQ scale (ΔDTSQM6-DTSQM0>0) (Diabetes Treatment Satisfaction Questionnaire) | 6 months | 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) | 6 months | 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 |
Countries
France
Outcome results
None listed