Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Percentage of time in target glucose range (3.9 - 10.0 mmol/L) |
The percentage of time in target glucose range will be assessed using continuous glucose monitoring (CGM). |
2 weeks |
|
Secondary |
Percentage of time above target (>10 mmol/L) |
The percentage of time below target (>10 mmol/L) will be assessed using continuous glucose monitoring (CGM). |
2 weeks |
|
Secondary |
Percentage of time below target (<3.9 mmol/L) |
The percentage of time below target (<3.9 mmol/L) will be assessed using continuous glucose monitoring (CGM). |
2 weeks |
|
Secondary |
Percentage of time in hypoglycemia (<3.0 mmol/L) |
The percentage of time in hypoglycemia (<3.0 mmol/L) will be assessed using continuous glucose monitoring (CGM). |
2 weeks |
|
Secondary |
Hypoglycemia burden quantified as the area under the curve (AUC) with glucose < 3 mmol/L |
Hypoglycemia burden will be assessed using continuous glucose monitoring (CGM). |
2 weeks |
|
Secondary |
Percentage of time in hyperglycemia (>16.7 mmol/L) |
The percentage of time in hyperglycemia (>16.7 mmol/L) will be assessed using continuous glucose monitoring (CGM). |
2 weeks |
|
Secondary |
Mean glucose levels (mmol/l) |
Mean sensor glucose levels will be assessed using continuous glucose monitoring (CGM). |
2 weeks |
|
Secondary |
Total daily insulin dose (U) |
Total daily insulin dose will be recorded by the insulin pump |
2 weeks |
|
Secondary |
Daily manual bolus Insulin dose (U) |
Daily manual bolus insulin dose will be recorded by the insulin pump |
2 weeks |
|
Secondary |
2 hour postprandial glucose increment (mmol/) |
2 hour postprandial glucose increment will be assessed using continuous glucose monitoring (CGM). |
2 weeks |
|
Secondary |
Within-day standard deviation of glucose (mmol/l) |
Within-day standard deviation of glucose will be assessed using continuous glucose monitoring (CGM). |
2 weeks |
|
Secondary |
Within day coefficient of variation of glucose (%) |
Within day coefficient of variation of glucose will be assessed using continuous glucose monitoring (CGM). |
2 weeks |
|
Secondary |
Between days coefficient of variation of glucose (%) |
Between days coefficient of variation of glucose will be assessed using continuous glucose monitoring (CGM). |
2 weeks |
|
Secondary |
Night-time percentage of time in target glucose range (3.9 - 10.0 mmol/L) |
Percentage of time in target glucose range will be assessed using continuous glucose monitoring (CGM). |
Between 00:00-06:00 over 2 weeks |
|
Secondary |
Night-time percentage of time above target (> 10.0 mmol/L) |
Percentage of time above target will be assessed using continuous glucose monitoring (CGM). |
Between 00:00-06:00 over 2 weeks |
|
Secondary |
Night-time percentage of time below target (< 3.9 mmol/L) |
Percentage of time below target will be assessed using continuous glucose monitoring (CGM). |
Between 00:00-06:00 over 2 weeks |
|
Secondary |
Night-time percentage of time in hypoglycemia (< 3.0 mmol/L) |
Percentage of time in hypoglycemia will be assessed using continuous glucose monitoring (CGM). |
Between 00:00-06:00 over 2 weeks |
|
Secondary |
Night-time percentage of time in hyperglycemia (> 16.7 mmol/L) |
Percentage of time in hyperglycemia will be assessed using continuous glucose monitoring (CGM). |
Between 00:00-06:00 over 2 weeks |
|
Secondary |
Night-time mean glucose levels |
Mean sensor glucose levels will be assessed using continuous glucose monitoring (CGM). |
Between 00:00-06:00 over 2 weeks |
|
Secondary |
Within night-time standard deviation of glucose (mmol/l)compared to within daytime period (06: - 24:00) standard deviation of glucose (mmol/l) |
Standard deviation of glucose will be assessed using continuous glucose monitoring (CGM). |
Between 00:00-06:00 over 2 weeks |
|
Secondary |
Within nighttime coefficient of variation of glucose(%) |
Coefficient of variation of glucose (%) will be assessed using continuous glucose monitoring (CGM). |
Between 00:00-06:00 over 2 weeks |
|
Secondary |
Change from baseline in lipid profile |
Plasma Lipid profile (total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides) |
2 weeks |
|
Secondary |
Total daily calorie intake (kcal/day) |
Total daily calorie intake will be assessed based on photo-documentation of dietary intake |
2 weeks |
|
Secondary |
Mean beta-hydroxy butyrate level |
based on download of blood Ketone meter |
2 weeks |
|
Secondary |
Change from baseline in fasting plasma metabolome |
Fasting serum sampling |
2 weeks |
|
Secondary |
Incidence of (serious) adverse events |
Incidence of severe hypoglycaemia, signficant hyperglycaemia with ketonemia, other SAEs, adverse events, adverse defice effects and device deficiencies |
12 weeks |
|
Secondary |
Percentage of time when pump was in Auto-mode |
Based on pump data download |
2 weeks |
|