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.
In recent years, closed-loop insulin delivery have been developed to deliver real-time glucose-responsive insulin to people with type 1 diabetes mellitus (T1DM). 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.
Study Type
OBSERVATIONAL
Enrollment
410
Follow up of patients with real-time closed-loop insulin delivery systems
CH Béthune-Beuvry
Béthune, France
CH Boulogne-sur-Mer
Boulogne-sur-Mer, France
CH Dax
Dax, France
CHI Mont de Marsan et du Pays des Sources
Mont-de-Marsan, France
CH Périgueux
Périgueux, France
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%
Time frame: At 3 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%
Time frame: 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%
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 12 months
Time Below Range
Percentage of time with glucose values below 70 mg/dL in the last 14 days
Time frame: At 3 months
Time Below Range
Percentage of time with glucose values below 70 mg/dL in the last 14 days
Time frame: At 6 months
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Time Below Range
Percentage of time with glucose values below 70 mg/dL in the last 14 days
Time frame: At 12 months
Time Above Range
Percentage of time with glucose values above 180 mg/dL in the last 14 days
Time frame: At 3 months
Time Above Range
Percentage of time with glucose values above 180 mg/dL in the last 14 days
Time frame: At 6 months
Time Above Range
Percentage of time with glucose values above 180 mg/dL in the last 14 days
Time frame: At 12 months
Coefficient of Variation
Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
Time frame: At 3 months
Coefficient of Variation
Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
Time frame: At 6 months
Coefficient of Variation
Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
Time frame: At 12 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%
Time frame: at 18 months
Time in Range
Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days
Time frame: at 18 months
Time Below Range
Percentage of time with glucose values below 70 mg/dL in the last 14 days
Time frame: at 18 months
Time Above Range
Percentage of time with glucose values above 180 mg/dL in the last 14 days
Time frame: at 18 months
Coefficient of Variation
Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
Time frame: at 18 months