Adolescents, Type1 Diabetes, Young Adults
Conditions
Keywords
type 1 diabetes, hybrid closed-loop, adolescents, young adults, HbA1c, TIR
Brief summary
The purpose of this study is to determine the effect of hybrid closed loop on glycemic outcomes in young patients aged between 15 and 25 years old with type 1 diabetes, whatever is their initial metabolic control.
Detailed description
Type 1 diabetes (T1D) constitutes a major public health challenge due to acute complications requiring emergency hospitalizations, as well as many chronic complications that need to be managed over the long term. However, these complications can be prevented by maintaining correct glycemic control, according to international guidelines. For the past few years, the arrival of new technologies as insulin pump and particularly Continuous Glucose Monitoring (CGM) showed a significant improvement on metabolic control. Nevertheless, adolescents and young adults with type 1 diabetes need a special focus because they still fail to meet glycemic control targets. At this time, hybrid closed loop, pairing Continuous Glucose Monitoring with insulin pump, enables insulin delivery in a semi-autonomous way thanks to algorithms, and leads to the best metabolic results we've never got in randomized trials and real-world studies.
Interventions
* Control IQ : T-Slim pump with Dexcom G6 * Smartguard : Medtronic 780G pump with Guardian G4S * Diabeloop : Kaliedo pump with Dexcom G6
Sponsors
Study design
Eligibility
Inclusion criteria
* Patient aged between 15 and 25 years old * Type 1 diabetes since at least 1 year at the moment of instauring HCL * At least 3 months of HCL use
Exclusion criteria
* Informed patient that have been opposed for their data collect
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c after HCL | at 3 months | Comparison of HbA1c (%) before and after HCL (at least 3 months of use) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of HCL | at 3 months | Percentage of use of HCL |
| HCL stop | at 3 months | number of HCL stop |
| Glycemic parameters with CGM | at 3 months | pourcentage time In Range (TIR) 70-180 mg/dl |
| HbA1c after HCL | at 6 months | Comparison of HbA1c (%) before and after HCL (at least 3 months of use) |
| retinopathy | at 3 months | Comparison of retinography results before HCL and after HCL |
| nephropathy | at 3 months | Comparison microalbuminuria/creatininuria dosage the year before HCL and after HCL |
| keto-acidosis and severe hypoglycemia | at 3 months | Comparision of keto-acidose and severe hypoglycemia events the year before HCL and after HCL |
Countries
France