Diabetes Mellitus, Type 1
Conditions
Keywords
diabetes type 1, closed loop insulin delivery system, continuous glucose monitoring, sensor-augmented pump
Brief summary
This study aims to compare glycemic control obtained under closed loop depending on the system : Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1.
Detailed description
Since 2021, several closed-loop insulin delivery systems have been reimbursed in France for patients living with type 1 diabetes. The real-life efficacy and safety of these systems have already been the subject of several publications, confirming the results of clinical trials. To date, there are no clinical trial comparing closed-loop systems. There are, however, a few observational studies that have attempted such a comparison, but with few patients included or a poorly adapted methodology. Given the size of the cohort of patients with type 1 diabetes fitted with a closed-loop system in the diabetology department of the Centre Hospitalier Sud-Francilien since 2021 (\> 400), we propose a single-center analysis to compare real-life performance of Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1 during a follow-up of 12 months and using a propensity score
Interventions
DEVICEInsulin closed-loop delivery system
Insulin closed-loop delivery system
Sponsors
Centre Hospitalier Sud Francilien
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Inclusion criteria
* Patient \> 16 years * Patient with diabetes type 1. * Patient treated with a CONTROL-IQ or SMARTGUARD closed-loop insulin delivery system between 01/2021 and 05/2022. * Follow-up patient in Centre Hospitalier Sud Francilien
Exclusion criteria
* Women who had pregnancy within 12 months of system initiation. * Patient who have been treated with both systems within 12 months. * Patient or parental authority objecting the use of data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of glycemic control obtained under closed loop according to the system used: SG versus CIQ | at 12 months | Time spent in target range (between 70 and 180 mg/dL) after 12 months following initiation of the closed-loop system, as measured by continuous glucose monitoring (CGM).system, as measured by continuous glucose monitoring (CGM). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time below target (< 70 mg/dL) | at 12 months | Compare glycemic control |
| Glycemic coefficient of variation (CV) | at 12 months | Compare glycemic control |
| daily insulin dose | at 12 months | Compare glycemic control |
| HBA1c | at 12 months | Compare glycemic control |
| weight daily insulin dose | at 12 months | Compare glycemic control |
| glucose management indicator | at 12 months | Compare glycemic control |
Countries
France
Outcome results
None listed