Insulin Delivery Using the DBLG1 Closed-loop on Glycemic Control and PROMs in Adults Living With Type 1 Diabetes

Change in the percentage of time spent in range (sensor glucose 70-180 mg/dL) from before start to 12 months after start of the DBLG1 system

Change in the percentage of time spent in range (sensor glucose 70-180 mg/dL) after start of the DBLG1 system, with exclusion of the primary endpoint

Change in the percentage of time spent in tigh range (sensor glucose 70-140 mg/dL) after start of the DBLG1 system.

Change in the percentage of time spent in level 2 hypoglycemia (sensor glucose below 54 mg/dL) after start of the DBLG1 system.

Change in the percentage of time spent in level 1 hypoglycemia (sensor glucose < 70 mg/dL and >=54 mg/dl) after start of the DBLG1 system.

Change in the percentage of time spent below range (sensor glucose < 70 mg/dL) after start of the DBLG1 system.

Change in the percentage of time spent above range (sensor glucose >180 mg/dL) after start of the DBLG1 system.

Change in the percentage of time spent in level 2 hyperglycemia (sensor glucose >250 mg/dL) after start of the DBLG1 system.

Change in the percentage of time spent in level 1 hyperglycemia (sensor glucose >180 mg/dL and <= 250 mg/dl)) after start of the DBLG1 system.

Change in Coefficient of variation (CV) and standard deviation (SD) after start of the DBLG1 system.

Change in mean glucose concentration after start of the DBLG1 system.

Change in HbA1c (%) after start of the DBLG1 system.

Correlation between recorded clinical characteristics and HbA1c changes after start of the DBLG1 system.

Change in Patient's Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))

Change in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (≥4 times "R" or once "U") or aware (<4 times "R"))

Change in hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware))

Change in fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))

Change in distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))

Impact of diabetes and device satisfaction by the Diabetes Impact and Device Satisfaction Scale (scale: device satisfaction = 7 (not satisfied) - 70 (very satisfied); diabetes impact = 4 (low impact) - 40 (high impact))

Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction))

Self-developed questionnaire about the reasons the patient stopped using the DBLG-1 device (multiple choice)

Composite endpoint of the percentage of participants reaching HbA1c <7% AND time in hypoglycemia (sensor glucose < 70 mg/dL) less than 4% of time after start of the DBLG1 system

Change in Severe Hypoglycemia frequency after start of the DBLG1 system

Change in diabetic ketoacidosis frequency after start of the DBLG1 system

Evolution of number of hospitals visits and/or admissions because of severe hypoglycemia or diabetic ketoacidosis from before start to 12 months after start of the DBLG1 system

Evolution of work and school absenteeism (number of days) after start of the DBLG1 system

Evolution of frequency of unplanned contacts with the diabetes team after start of the DBLG1 system

Evolution of body weight (kg) after start of the DBLG1 system

Evolution of total daily dose of insulin after start of the DBLG1 system

Indications for use of the DBLG-1 system measured by a self-developed questionnaire (multiple options (non-ordinal))

Number of patients who stop using the DBLG-1 system