Insulin Delivery Using the DBLG1 Closed-loop on Glycemic Control and PROMs in Adults Living With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Insulin Delivery Using the DBLG1 Closed-loop Algorithm on Glycemic Control and Patient-reported Outcomes in Adults Living With Type 1 Diabetes: a Multicenter Real-world Observational Study in Belgium

Conditions
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Diabetes Mellitus, Type 1

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with type 1 diabetes aged 18 years and older starting with the DBLG1 system in the participating centers who signed the informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |