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While closed-loop insulin delivery (CLID) systems demonstrated safety and effectiveness in patients with unbalanced type 1 diabetes (T1D), no studies have included patients with highly and chronically unbalanced diabetes.
The investigators conduct a retrospective, observational, and single-center study to evaluate the acceptability, safety, and efficacy of a CLID system in patients living with T1D (≥2 years) with a HbA1c>11% in the past 12 months and a mean HbA1c >10% over the past three years. Efficacy was assessed using continuous glucose monitoring parameters.
If hybrid closed-loop systems (HCLS) ("artificial pancreas") for automated insulin administration have demonstrated their great interest in patients living with moderately unbalanced type 1 diabetes (T1D) (HbA1c < 8 .6% on average), no study has looked at their safety, acceptability and efficacy in patients living with highly and chronically unbalanced T1D (HbA1c > 11%). These patients, often young, present more or less advanced microangiopathic complications (retinopathy, nephropathy, neuropathy, etc.) or are highly exposed to the appearance of these complications, the prevention of which, whether primary or secondary, involves obtaining a good glycemic balance over time. These patients "escape" the possibilities of current insulin therapy, whether by multiple insulin injections or by insulin pump, more or less coupled to a continuous glucose monitoring system. Automated insulin delivery systems could be a solution to achieve less catastrophic glycemic control in some of these patients. The investigators are proposing a pilot study aimed at evaluating acceptability, safety and effectiveness of a HCLS currently available in France (the SMARTGUARDâ„¢ MINIMEDâ„¢ 780G or the Control-IQ) in patients followed in the diabetology department of the Centre Hospitalier Sud-Francilien (CHSF), living with highly unbalanced T1D (HbA1c > 11%) in the context of usual follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with hybrid closed-loop systems |
| ||
| Patient without hybrid closed-loop systems |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| device | Other | closed-loop insulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of hybrid closed-loop systems | Maintenance rate of a hybrid closed-loop system in patients living with highly unbalanced T1D (HbA1c > 11%) and followed in the diabetes department of the CHSF | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic characteristics : age | year
|
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Inclusion Criteria:
Patients with closed loop system :
Patients without closed loop system :
Adult patients
Exclusion Criteria:
Patients with closed loop system :
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Patients followed in the diabetes department of the Centre Hospitalier Sud Francilien
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penfornis | Corbeil-Essonnes | Centre Hospitalier Sud Francilien | 91106 | France | ||
| Centre Hospitalier Sud Francilien |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37955849 | Derived | Deepchand S, Balla V, Eroukhmanoff J, Ly Sall K, Romain B, Lejeune M, Penfornis A, Amadou C. Closed-Loop Insulin Delivery Systems for People with Type 1 Diabetes and Chronic Very Poor Metabolic Control: It Works and Is Safe! Diabetes Technol Ther. 2024 Feb;26(2):125-129. doi: 10.1089/dia.2023.0379. Epub 2024 Jan 11. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| at day 0 |
| Demographic characteristics : gender | feminine or masculine
| at day 0 |
| Demographic characteristics : level of education | year | at day 0 |
| Demographic characteristics : currrent activity | student, active, retired, unemployed, etc. | at day 0 |
| Demographic characteristics : duration of diabete | year | at day 0 |
| HbA1c | HbA1c | at day 0 |
| Efficiency |
| At baseline, 3, 6, and 12 months |
| Quality | Questionnaire Diabetes Quality of life : from 1 ( very satisfaying) to 5 (very unsatisfactory) | At baseline, 3, 6, and 12 months |
| Patient satisfaction | Questionnaire Diabetes Quality of life : from 3 (many) to -3 (less) | At baseline, 3, 6, and 12 months |
| Hypoglycemia Fear | Hypoglycemia Fear Survey : from 0 (never) to 4 (almost always) | At baseline, 3, 6, and 12 months |
| Corbeil-Essonnes |
| 91106 |
| France |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |