Diabetes Mellitus, Type 1INLOOPNCT06154135
Insulin Delivery Using the DBLG1 Closed-loop on Glycemic Control and PROMs in Adults Living With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1, run by Erasme University Hospital at 12 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- How many people
- 165 participants
- Where
- 12 sitesBelgium
- Study dates
- 30 Dec 2022to 30 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with T1D, aged 18 years and older, who start with the DBLG1 system in Belgium
Who may be able to join
- patients with type 1 diabetes
- aged 18 years and older
- starting with the DBLG1 system in the participating centers
- who signed the informed consent
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Belgium12 sites
Department of Endocrinology, OLVZ Aalst
Aalst, 9300
Department of Endocrinology, Imeldaziekenhuis
Bonheiden, 2820
Department of Endocrinology, ULB-Hôpital Erasme
Brussels, 1070
Department of Endocrinology and Nutrition, Cliniques Universitaires St. Luc
Brussels, 1200
Department of Endocrinology, UZ Antwerpen
Edegem, 2650
Department of Endocrinology and metabolic diseases, UZ Gent
Ghent, 9000
Department of Endocrino-Diabetology, Grand Hôpital de Charleroi - site Saint-Joseph
Gilly, 6060
Department of Endocrinology, UZ Leuven
Leuven, 3000
Department of Diabetes, Nutrition and Metabolic disorders, CHU de Liège - site du Sart Tilman
Liège, 4000
Department of Endocrinology, CHR de la Citadelle
Liège, 4000
Department of internal Medicine, CHU de Charleroi - Hôpital Civil Marie Curie
Lodelinsart, 6042
Department of Endocrinology, CHR Mons-Hainaut (Warquignies)
Mons, 7000
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months after start
Secondary outcomes (20)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from before start to 4,8,12 and 24 months after start
HbA1c
Change in HbA1c (%) after start of the DBLG1 system.
Measured: 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.
Measured: 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))
Measured: 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"))
Measured: 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))
Measured: 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))
Measured: 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))
Measured: 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))
Measured: 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))
Measured: 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)
Measured: when the patient stops using the DBLG-1 system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start30 Dec 2022
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Crenier, PhD, Principal investigator, CUB - Hôpital Erasme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154135
- Sponsor's protocol ID
- SRB2022123
- Acronym
- INLOOP
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol is published online
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06154135
- Acronym / sponsor ID
- INLOOP / SRB2022123
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with T1D, aged 18 years and older, who start with the DBLG1 system in Belgium
Key inclusion criteria (4 listed)
- patients with type 1 diabetes
- aged 18 years and older
- starting with the DBLG1 system in the participating centers
- who signed the informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time in range
Time frame: 12 months after start
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
20 secondary outcomes
Time in range [exc. primary outcome]
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
Time frame: from before start to 4,8,12 and 24 months after start
Time in level 2 hypoglycemia
Time frame: from before start to 4,8,12 and 24 months after start
Time in level 1 hypoglycemia
Time frame: from before start to 4,8,12 and 24 months after start
Time below range
Time frame: from before start to 4,8,12 and 24 months after start
Time above range
Time frame: from before start to 4,8,12 and 24 months after start
Time in level 2 hyperglycemia
Time frame: from before start to 4,8,12 and 24 months after start
Time in level 1 hyperglycemia
Time frame: from before start to 4,8,12 and 24 months after start
Glycemic variability
Time frame: from before start to 4,8,12 and 24 months after start
Mean glucose concentration
Time frame: from before start to 4,8,12 and 24 months after start
HbA1c
Time frame: from before start to 4,8,12 and 24 months after start
Correlation between clinical characteristics and HbA1c changes
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
Time frame: from before start to 4,8,12 and 24 months after start
Clarke hypoglycemia awareness survey
Time frame: from before start to 4,8,12 and 24 months after start
Gold scale
Time frame: from before start to 4,8,12 and 24 months after start
Hypoglycemia Fear Survey (HFS-II)
Time frame: from before start to 4,8,12 and 24 months after start
PAID-SF questionnaire
Time frame: from before start to 4,8,12 and 24 months after start
Diabetes Impact and Device Satisfaction Scale (DIDSS)
Time frame: from before start to 4,8,12 and 24 months after start
Diabetes Treatment Satisfaction Questionnaire, Status (DTSQs)
Time frame: from before start to 4,8,12 and 24 months after start
Reasons to stop using the DBLG-1 device
Time frame: when the patient stops using the DBLG-1 system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: Yes. The protocol is published online
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Crenier, PhD principal investigator
CUB - Hôpital Erasme
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Erasme University Hospital at 12 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: 12 months after start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.