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To evaluate the impact of the DBLG1 hybrid closed-loop system on glycemic control and patient-reported outcomes in adults living with type 1 diabetes under real-life conditions.
This is a multicenter real-world observational study analyzing data on the use of the DBLG1 system in patients with T1D treated in the participating centers in Belgium. Data from patients with T1D who start(ed) with the DBLG1 between may-01 2022 up to and including August-01 2023 will be analyzed. Data will be collected during clinical routine follow-up from electronic medical records, questionnaires, standard of care laboratory tests and CGM-data. Baseline data from before start (up to -12 months) of the DBLG1 system and follow-up data at 4, 8, 12, 16, 20 and 24 months will be analyzed. There are no medical interventions, nor extra visits or laboratory tests planned outside normal clinical routine. Glycemic control and patient-reported outcomes during follow-up will be compared with glycemic control and patient-reported outcome data at baseline.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time in tigh range |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Severe hypoglycemia |
Inclusion Criteria:
Exclusion Criteria:
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Patients with T1D, aged 18 years and older, who start with the DBLG1 system in Belgium
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Crenier, PhD | CUB - Hôpital Erasme | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, OLVZ Aalst | Aalst | 9300 | Belgium | |||
| Department of Endocrinology, Imeldaziekenhuis |
The protocol is published online
Available since May,1 2022
open access
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| HbA1c | Change in HbA1c (%) after start of the DBLG1 system. | from before start to 4,8,12 and 24 months after start |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Change in Severe Hypoglycemia frequency after start of the DBLG1 system |
| from before start to 4,8,12 and 24 months after start |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Bonheiden |
| 2820 |
| Belgium |
| Department of Endocrinology, ULB-Hôpital Erasme | Brussels | 1070 | Belgium |
| Department of Endocrinology and Nutrition, Cliniques Universitaires St. Luc | Brussels | 1200 | Belgium |
| Department of Endocrinology, UZ Antwerpen | Edegem | 2650 | Belgium |
| Department of Endocrinology and metabolic diseases, UZ Gent | Ghent | 9000 | Belgium |
| Department of Endocrino-Diabetology, Grand Hôpital de Charleroi - site Saint-Joseph | Gilly | 6060 | Belgium |
| Department of Endocrinology, UZ Leuven | Leuven | 3000 | Belgium |
| Department of Diabetes, Nutrition and Metabolic disorders, CHU de Liège - site du Sart Tilman | Liège | 4000 | Belgium |
| Department of Endocrinology, CHR de la Citadelle | Liège | 4000 | Belgium |
| Department of internal Medicine, CHU de Charleroi - Hôpital Civil Marie Curie | Lodelinsart | 6042 | Belgium |
| Department of Endocrinology, CHR Mons-Hainaut (Warquignies) | Mons | 7000 | Belgium |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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