An observational study in Diabetes Mellitus, Type 1, sponsored by Erasme University Hospital. Enrolling by invitation at 12 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Erasme University Hospital · Observational
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's planned enrollment of 165 is below the median of 233 across 2,218 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Erasme University Hospital is the lead sponsor of 178 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with T1D, aged 18 years and older, who start with the DBLG1 system in Belgium
Exclusion Criteria:
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
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
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
Time frame: from before start to 4,8,12 and 24 months after start
Severe hypoglycemia
Change in Severe Hypoglycemia frequency after start of the DBLG1 system
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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))
Time frame: before start
Patients who stop using the DBLG-1 system
Number of patients who stop using the DBLG-1 system
Time frame: from 4,8,12 and 24 months after start
Plan to share: Yes — The protocol is published online
Supporting information: Study protocol
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Erasme University Hospital