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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetes Mellitus, Type 1

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.

• Study Type: Observational
• Enrollment (Estimated): 165

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Department of Endocrinology, OLVZ Aalst
  • Bonheiden, Belgium, 2820
    • Department of Endocrinology, Imeldaziekenhuis
  • Brussels, Belgium, 1070
    • Department of Endocrinology, ULB-Hôpital Erasme
  • Brussels, Belgium, 1200
    • Department of Endocrinology and Nutrition, Cliniques Universitaires St. Luc
  • Edegem, Belgium, 2650
    • Department of Endocrinology, UZ Antwerpen
  • Gent, Belgium, 9000
    • Department of Endocrinology and metabolic diseases, UZ Gent
  • Gilly, Belgium, 6060
    • Department of Endocrino-Diabetology, Grand Hôpital de Charleroi - site Saint-Joseph
  • Leuven, Belgium, 3000
    • Department of Endocrinology, UZ Leuven
  • Liege, Belgium, 4000
    • Department of Endocrinology, CHR de la Citadelle
  • Liège, Belgium, 4000
    • Department of Diabetes, Nutrition and Metabolic disorders, CHU de Liège - site du Sart Tilman
  • Lodelinsart, Belgium, 6042
    • Department of internal Medicine, CHU de Charleroi - Hôpital Civil Marie Curie
  • Mons, Belgium, 7000
    • Department of Endocrinology, CHR Mons-Hainaut (Warquignies)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with T1D, aged 18 years and older, who start with the DBLG1 system in Belgium

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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))	before start
Patients who stop using the DBLG-1 system	Number of patients who stop using the DBLG-1 system	from 4,8,12 and 24 months after start

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: Laurent Crenier, PhD, CUB - Hôpital Erasme

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2022
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: SRB2022123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The protocol is published online
• IPD Sharing Time Frame: Available since May,1 2022
• IPD Sharing Access Criteria: open access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No