Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Composite endpoint of HbA1c and Time in Hypoglycemia |
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 |
from before start to 4,8,12 and 24 months after start |
|
| Other |
Severe hypoglycemia |
Change in Severe Hypoglycemia frequency after start of the DBLG1 system |
from before start to 4,8,12 and 24 months after start |
|
| Other |
Diabetic ketoacidosis |
Change in diabetic ketoacidosis frequency after start of the DBLG1 system |
from before start to 4,8,12 and 24 months after start |
|
| Other |
Hospitals visits and/or admissions |
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 |
from before start to 4,8,12 and 24 months after start |
|
| Other |
Work and school absenteeism |
Evolution of work and school absenteeism (number of days) after start of the DBLG1 system |
from before start to 4,8,12 and 24 months after start |
|
| Other |
Unplanned contacts with the diabetes team |
Evolution of frequency of unplanned contacts with the diabetes team after start of the DBLG1 system |
from before start to 4,8,12 and 24 months after start |
|
| Other |
Change in body weight |
Evolution of body weight (kg) after start of the DBLG1 system |
from before start to 4,8,12 and 24 months after start |
|
| Other |
Change in total daily dose of insulin |
Evolution of total daily dose of insulin after start of the DBLG1 system |
from before start to 4,8,12 and 24 months after start |
|
| Other |
Indications for use of the DBLG-1 system (multiple options (non-ordinal)) |
Indications for use of the DBLG-1 system measured by a self-developed questionnaire (multiple options (non-ordinal)) |
before start |
|
| Other |
Patients who stop using the DBLG-1 system |
Number of patients who stop using the DBLG-1 system |
from 4,8,12 and 24 months after start |
|
| Primary |
Time in range |
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 |
12 months after start |
|
| Secondary |
Time in range [exc. primary outcome] |
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 |
from before start to 4,8,12 and 24 months after start, with the exclusion of the primary outcome |
|
| Secondary |
Time in tigh range |
Change in the percentage of time spent in tigh range (sensor glucose 70-140 mg/dL) after start of the DBLG1 system. |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Time in level 2 hypoglycemia |
Change in the percentage of time spent in level 2 hypoglycemia (sensor glucose below 54 mg/dL) after start of the DBLG1 system. |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Time in level 1 hypoglycemia |
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. |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Time below range |
Change in the percentage of time spent below range (sensor glucose < 70 mg/dL) after start of the DBLG1 system. |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Time above range |
Change in the percentage of time spent above range (sensor glucose >180 mg/dL) after start of the DBLG1 system. |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Time in level 2 hyperglycemia |
Change in the percentage of time spent in level 2 hyperglycemia (sensor glucose >250 mg/dL) after start of the DBLG1 system. |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Time in level 1 hyperglycemia |
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. |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Glycemic variability |
Change in Coefficient of variation (CV) and standard deviation (SD) after start of the DBLG1 system. |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Mean glucose concentration |
Change in mean glucose concentration after start of the DBLG1 system. |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
HbA1c |
Change in HbA1c (%) after start of the DBLG1 system. |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Correlation between clinical characteristics and HbA1c changes |
Correlation between recorded clinical characteristics and HbA1c changes after start of the DBLG1 system. |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 |
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)) |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Clarke hypoglycemia awareness survey |
Change in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (=4 times "R" or once "U") or aware (<4 times "R")) |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Gold scale |
Change in hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware)) |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Hypoglycemia Fear Survey (HFS-II) |
Change in fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried)) |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
PAID-SF questionnaire |
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)) |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Diabetes Impact and Device Satisfaction Scale (DIDSS) |
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)) |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Diabetes Treatment Satisfaction Questionnaire, Status (DTSQs) |
Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction)) |
from before start to 4,8,12 and 24 months after start |
|
| Secondary |
Reasons to stop using the DBLG-1 device |
Self-developed questionnaire about the reasons the patient stopped using the DBLG-1 device (multiple choice) |
when the patient stops using the DBLG-1 system |
|
