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.
Study Type
OBSERVATIONAL
Enrollment
165
Department of Endocrinology, OLVZ Aalst
Aalst, Belgium
Department of Endocrinology, Imeldaziekenhuis
Bonheiden, Belgium
Department of Endocrinology, ULB-Hôpital Erasme
Brussels, Belgium
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
Time frame: 12 months after start
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: from before start to 4,8,12 and 24 months after start
Time above range
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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
Ghent, Belgium
Department of Endocrino-Diabetology, Grand Hôpital de Charleroi - site Saint-Joseph
Gilly, Belgium
Department of Endocrinology, UZ Leuven
Leuven, Belgium
Department of Diabetes, Nutrition and Metabolic disorders, CHU de Liège - site du Sart Tilman
Liège, Belgium
Department of Endocrinology, CHR de la Citadelle
Liège, Belgium
...and 2 more locations
Change in the percentage of time spent above range (sensor glucose \>180 mg/dL) after start of the DBLG1 system.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: from before start to 4,8,12 and 24 months after start
HbA1c
Change in HbA1c (%) after start of the DBLG1 system.
Time frame: 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.
Time frame: 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))
Time frame: 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"))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: 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)
Time frame: when the patient stops using the DBLG-1 system