Real-life Data From Diabetic Patients on Closed-loop Pumps

Study Overview
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Brief Summary
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To evaluate, in real life, the effect of closed-loop devices on the improvement of glycemic control in diabetic patients managed in the endocrinology departments of secondary care hospitals.

Detailed Description
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In recent years, closed-loop insulin delivery have been developed to deliver real-time glucose-responsive insulin to people with type 1 diabetes. Their use has been validated in clinical trials, but international investigative centers participating in clinical trials are not always representative of secondary care centers, and the patients they manage are also different. The eligibility criteria for participants in clinical trials are more stringent and restrictive than those of the usual patient population of diabetes/endocrinology centers. The socio-demographic characteristics of patients in clinical trials, in particular the ratio of males to females, age or ethnicity, do not necessarily reflect those observed in patients actually using the device.

Official Title
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Real-life Data From Diabetic Patients on Closed-loop Pumps

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: closed-loop insulin pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type I diabetic with a closed-loop insulin pump Exclusion Criteria: under legal protection order patient or legal guardian objecting to the use of the data in the research

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type I diabetic patient<br> | Device: closed-loop insulin pump<br>* Follow up of patients with real-time closed-loop insulin delivery systems<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c level | Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6% | At 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c level | Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6% | At 6 months | 
| HbA1c level | Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6% | At 12 months | 
| Time in range | Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days | At 3 months | 
| Time in range | Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days | At 6 months | 
| Time in range | Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days | At 12 months | 
| Time below range | Percentage of time with glucose values below 70 mg/dL in the last 14 days | At 3 months | 
| Time below range | Percentage of time with glucose values below 70 mg/dL in the last 14 days | At 6 months | 
| Time below range | Percentage of time with glucose values below 70 mg/dL in the last 14 days | At 12 months | 
| Time above range | Percentage of time with glucose values above 180 mg/dL in the last 14 days | At 3 months | 
| Time above range | Percentage of time with glucose values above 180 mg/dL in the last 14 days | At 6 months | 
| Time above range | Percentage of time with glucose values above 180 mg/dL in the last 14 days | At 12 months | 
| Coefficient of variation | Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage) | At 3 months | 
| Coefficient of variation | Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage) | At 6 months | 
| Coefficient of variation | Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage) | At 12 months |