Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Total daily basal insulin dose |
Mean total daily basal insulin dose infused |
From the first day of the respective study period to 3 months thereafter |
|
| Other |
Total daily bolus insulin dose |
Mean total daily bolus insulin dose infused |
From the first day of the respective study period to 3 months thereafter |
|
| Other |
Percentage of time of closed-loop operation including engagement with specific functionalities |
Utility evaluation |
From the first day of the respective study period to 3 months thereafter |
|
| Other |
Diabetes Distress Scale |
Measurement of distress associated with the use of closed-loop insulin delivery using the Diabetes Distress questionnaire |
At the predefined study visit 3 months after the start of the respective period. |
|
| Other |
Hypoglycaemia confidence scale |
HCS is a 9-item self-report scale that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems |
At the predefined study visit 3 months after the start of the respective period. |
|
| Other |
Psychosocial factors important to quality of life |
These factors include anxiety, stress, depressions, etc. |
At the predefined study visit 3 months after the start of the respective period. |
|
| Other |
Food Frequency Questionnaire to assess dietary intake habits |
Dietary intake (quantity and quality) |
At the predefined study visit 3 months after the start of the respective period. |
|
| Other |
Number of severe hypoglycaemia events |
Hypoglycaemia requiring third-party assistance to administer carbohydrates or other resuscitative action |
From the first day of the respective study period to 3 months thereafter |
|
| Other |
Diabetic ketoacidosis |
ADA definition |
From the first day of the respective study period to 3 months thereafter |
|
| Other |
Significant ketonaemia |
Value > 3.0 mmol/L |
From the first day of the respective study period to 3 months thereafter |
|
| Other |
Nature and severity of adverse events |
AE including SADE and SAE |
From the first day of the respective study period to 3 months thereafter |
|
| Primary |
Percentage of time with sensor glucose measurements between 3.9 and 10.0 mmol/L |
The percentage of time with sensor glucose measurements between 3.9 and 10.0 mmol/L will be compared between both intervention arms. Primary analysis will be carried out according to a non-inferiority framework. |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Time spent with sensor glucose values above target (>10.0 mmol/L) |
Percentage of time spent with sensor glucose values above target (>10.0 mmol/L) |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Time spent with sensor glucose values >13.9 mmol/L (%) |
Percentage of time spent with sensor glucose values >13.9 mmol/L (%) |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Time spent with sensor glucose measurements < 3.9 mmol/L |
The percentage of time with sensor glucose measurements < 3.9 mmol/L (%) |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Time spent with sensor glucose measurements < 3.0 mmol/L |
The percentage of time with sensor glucose measurements < 3.0 mmol/L (%) |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Time spent with sensor glucose measurements between < 3.9 mmol/L and 7.8 mmol/L (%) |
The percentage of time with sensor glucose between < 3.9 mmol/L and 7.8 mmol/L (%) |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Mean sensor glucose level (mmol/L) |
Mean of all sensor glucose levels (mmol/L) |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
HbA1c |
Glycated hemoglobin A1c (%) |
At baseline and at the predefined study visits (3 months after the start of the respective periods) |
|
| Secondary |
Mean peak postprandial glucose |
Mean peak postprandial glucose (mmol/L) assessed within 180min following main meals (defined as carbohydrate amounts >25g entered into the CamAPS app by the participants). |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Coefficient of sensor glucose variation (%) |
Coefficient of sensor glucose variation (%) |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Standard deviation of sensor glucose variation (mmol/L) |
Standard deviation of sensor glucose variation (mmol/L) |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Glucose Management Indicator (%) |
Glucose Management Indicator (%) |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Number of clinically significant hypoglycaemia (number of events with sensor glucose <3.9 mmol/L for at least 15min) |
Number of events with sensor glucose <3.9 mmol/L for at least 15min |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Extended hypoglycaemia event rate (number of events with sensor glucose <3.9 mmol/L lasting at least 120min) |
Number of events with sensor glucose <3.9 mmol/L lasting at least 120min |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Extended hyperglycaemia event rate (number of events with sensor glucose >13.9 mmol/L lasting at least 120min) |
Number of events with sensor glucose >13.9 mmol/L lasting at least 120min |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Proportion of participants with sensor glucose in the target range (3.9 - 10.0 mmol/L for >70% of the time. |
Proportion of participants with sensor glucose in the target range (3.9 - 10.0 mmol/L for >70% of the time. |
From the first day of the respective study period to 3 months thereafter |
|
