Insulin Delivery Using the DBLG1 Closed-loop on Glycemic Control and PROMs in Adults Living With Type 1 Diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Registration Number
- NCT06154135
- Lead Sponsor
- Erasme University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 165
- patients with type 1 diabetes
- aged 18 years and older
- starting with the DBLG1 system in the participating centers
- who signed the informed consent
- patients who do not have type 1 diabetes
- younger than 18 years
- who do not start with the DBLG1 system
- who are not able to sign the informed consent
- who do not want to sign the informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time in range 12 months after start 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
- Secondary Outcome Measures
Name Time Method Time in range [exc. primary outcome] from before start to 4,8,12 and 24 months after start, with the exclusion of the 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
Correlation between clinical characteristics and HbA1c changes from before start to 4,8,12 and 24 months after start Correlation between recorded clinical characteristics and HbA1c changes after start of the DBLG1 system.
Time in tigh range from before start to 4,8,12 and 24 months after start Change in the percentage of time spent in tigh range (sensor glucose 70-140 mg/dL) after start of the DBLG1 system.
Time in level 2 hypoglycemia from before start to 4,8,12 and 24 months after start Change in the percentage of time spent in level 2 hypoglycemia (sensor glucose below 54 mg/dL) after start of the DBLG1 system.
Time in level 1 hypoglycemia from before start to 4,8,12 and 24 months after start 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.
Time above range from before start to 4,8,12 and 24 months after start Change in the percentage of time spent above range (sensor glucose \>180 mg/dL) after start of the DBLG1 system.
Time in level 2 hyperglycemia from before start to 4,8,12 and 24 months after start Change in the percentage of time spent in level 2 hyperglycemia (sensor glucose \>250 mg/dL) after start of the DBLG1 system.
Time in level 1 hyperglycemia from before start to 4,8,12 and 24 months after start 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.
Clarke hypoglycemia awareness survey from before start to 4,8,12 and 24 months after start Change in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (≥4 times "R" or once "U") or aware (\<4 times "R"))
Gold scale from before start to 4,8,12 and 24 months after start Change in hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware))
Time below range from before start to 4,8,12 and 24 months after start Change in the percentage of time spent below range (sensor glucose \< 70 mg/dL) after start of the DBLG1 system.
Glycemic variability from before start to 4,8,12 and 24 months after start Change in Coefficient of variation (CV) and standard deviation (SD) after start of the DBLG1 system.
Mean glucose concentration from before start to 4,8,12 and 24 months after start Change in mean glucose concentration after start of the DBLG1 system.
HbA1c from before start to 4,8,12 and 24 months after start Change in HbA1c (%) after start of the DBLG1 system.
Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 from before start to 4,8,12 and 24 months after start 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))
Hypoglycemia Fear Survey (HFS-II) from before start to 4,8,12 and 24 months after start Change in fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))
PAID-SF questionnaire from before start to 4,8,12 and 24 months after start 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))
Diabetes Impact and Device Satisfaction Scale (DIDSS) from before start to 4,8,12 and 24 months after start 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))
Diabetes Treatment Satisfaction Questionnaire, Status (DTSQs) from before start to 4,8,12 and 24 months after start Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction))
Reasons to stop using the DBLG-1 device when the patient stops using the DBLG-1 system Self-developed questionnaire about the reasons the patient stopped using the DBLG-1 device (multiple choice)
Trial Locations
- Locations (12)
Department of Endocrinology, OLVZ Aalst
🇧🇪Aalst, Belgium
Department of Endocrinology, Imeldaziekenhuis
🇧🇪Bonheiden, Belgium
Department of Endocrinology, ULB-Hôpital Erasme
🇧🇪Brussels, Belgium
Department of Endocrinology and Nutrition, Cliniques Universitaires St. Luc
🇧🇪Brussels, Belgium
Department of Endocrinology, UZ Antwerpen
🇧🇪Edegem, Belgium
Department of Endocrinology and metabolic diseases, UZ Gent
🇧🇪Gent, Belgium
Department of Endocrino-Diabetology, Grand Hôpital de Charleroi - site Saint-Joseph
🇧🇪Gilly, Belgium
Department of Endocrinology, UZ Leuven
🇧🇪Leuven, Belgium
Department of Endocrinology, CHR de la Citadelle
🇧🇪Liege, Belgium
Department of Diabetes, Nutrition and Metabolic disorders, CHU de Liège - site du Sart Tilman
🇧🇪Liège, Belgium
Scroll for more (2 remaining)Department of Endocrinology, OLVZ Aalst🇧🇪Aalst, Belgium