Clinical trial NCT06154135: Insulin Delivery Using the DBLG1 Closed-loop on Glycemic Control and PROMs in Adults Living With Type 1 Diabetes
Official title: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with T1D, aged 18 years and older, who start with the DBLG1 system in Belgium

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time in range
timeFrame: 12 months after start
Secondary outcomes:
measure: Time in range [exc. primary outcome]
timeFrame: from before start to 4,8,12 and 24 months after start, with the exclusion of the primary outcome
measure: Time in tigh range
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Time in level 2 hypoglycemia
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Time in level 1 hypoglycemia
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Time below range
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Time above range
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Time in level 2 hyperglycemia
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Time in level 1 hyperglycemia
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Glycemic variability
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Mean glucose concentration
timeFrame: from before start to 4,8,12 and 24 months after start
measure: HbA1c
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Correlation between clinical characteristics and HbA1c changes
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Clarke hypoglycemia awareness survey
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Gold scale
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Hypoglycemia Fear Survey (HFS-II)
timeFrame: from before start to 4,8,12 and 24 months after start
measure: PAID-SF questionnaire
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Diabetes Impact and Device Satisfaction Scale (DIDSS)
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Diabetes Treatment Satisfaction Questionnaire, Status (DTSQs)
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Reasons to stop using the DBLG-1 device
timeFrame: when the patient stops using the DBLG-1 system
Other outcomes:
measure: Composite endpoint of HbA1c and Time in Hypoglycemia
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Severe hypoglycemia
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Diabetic ketoacidosis
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Hospitals visits and/or admissions
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Work and school absenteeism
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Unplanned contacts with the diabetes team
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Change in body weight
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Change in total daily dose of insulin
timeFrame: from before start to 4,8,12 and 24 months after start
measure: Indications for use of the DBLG-1 system (multiple options (non-ordinal))
timeFrame: before start
measure: Patients who stop using the DBLG-1 system
timeFrame: from 4,8,12 and 24 months after start
Locations:
city: Aalst
country: Belgium
facility: Department of Endocrinology, OLVZ Aalst
city: Bonheiden
country: Belgium
facility: Department of Endocrinology, Imeldaziekenhuis
city: Brussels
country: Belgium
facility: Department of Endocrinology, ULB-Hôpital Erasme
city: Brussels
country: Belgium
facility: Department of Endocrinology and Nutrition, Cliniques Universitaires St. Luc
city: Edegem
country: Belgium
facility: Department of Endocrinology, UZ Antwerpen
city: Gent
country: Belgium
facility: Department of Endocrinology and metabolic diseases, UZ Gent
city: Gilly
country: Belgium
facility: Department of Endocrino-Diabetology, Grand Hôpital de Charleroi - site Saint-Joseph
city: Leuven
country: Belgium
facility: Department of Endocrinology, UZ Leuven
city: Liege
country: Belgium
facility: Department of Endocrinology, CHR de la Citadelle
city: Liège
country: Belgium
facility: Department of Diabetes, Nutrition and Metabolic disorders, CHU de Liège - site du Sart Tilman
city: Lodelinsart
country: Belgium
facility: Department of internal Medicine, CHU de Charleroi - Hôpital Civil Marie Curie
city: Mons
country: Belgium
facility: Department of Endocrinology, CHR Mons-Hainaut (Warquignies)
Study officials:
affiliation: CUB - Hôpital Erasme
name: Laurent Crenier, PhD
role: PRINCIPAL_INVESTIGATOR
References: