Diabetes Mellitus, Type 1COMPARE-CLIDSNCT05932966
Comparison With Observational Methods and Performance Assessment From Real-life Experience of Closed-Loop Insulin Delivery Systems
An observational study of Diabetes Mellitus, Type 1, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
This study aims to compare glycemic control obtained under closed loop depending on the system : Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin closed-loop delivery system
- Type of treatment
- Medical device
- How many people
- 317 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2023to 11 Jul 2024
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: The population will be selected from the diabetes department of a French public hospital. All eligible patients will be included in the study.
Who may be able to join
- Patient > 16 years
- Patient with diabetes type 1.
- Patient treated with a CONTROL-IQ or SMARTGUARD closed-loop insulin delivery system between 01/2021 and 05/2022.
- Follow-up patient in Centre Hospitalier Sud Francilien
Who cannot join
- Women who had pregnancy within 12 months of system initiation.
- Patient who have been treated with both systems within 12 months.
- Patient or parental authority objecting the use of data
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare glycemic control obtained under closed loop depending on the system : Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1.
Read the detailed description
Since 2021, several closed-loop insulin delivery systems have been reimbursed in France for patients living with type 1 diabetes. The "real-life" efficacy and safety of these systems have already been the subject of several publications, confirming the results of clinical trials.
To date, there are no clinical trial comparing closed-loop systems. There are, however, a few observational studies that have attempted such a comparison, but with few patients included or a poorly adapted methodology.
Given the size of the cohort of patients with type 1 diabetes fitted with a closed-loop system in the diabetology department of the Centre Hospitalier Sud-Francilien since 2021 (> 400), we propose a single-center analysis to compare real-life performance of Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1 during a follow-up of 12 months and using a propensity score
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin closed-loop delivery system
- Keywords
- diabetes type 1, closed loop insulin delivery system, continuous glucose monitoring, sensor-augmented pump
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin closed-loop delivery systemDevice
Insulin closed-loop delivery system
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 1 Diabetes equipped with control-IQ closed loop system | Patients with type 1 Diabetes equipped with control-IQ closed loop system Receives: Device: Insulin closed-loop delivery system | |
| Patients with type 1 diabetes equipped with Smart GUARD closed loop system | Patients with type 1 diabetes equipped with Smart GUARD closed loop system Receives: Device: Insulin closed-loop delivery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of glycemic control obtained under closed loop according to the system used: SG versus CIQ
Time spent in target range (between 70 and 180 mg/dL) after 12 months following initiation of the closed-loop system, as measured by continuous glucose monitoring (CGM).system, as measured by continuous glucose monitoring (CGM).
Measured: at 12 months
Secondary outcomes (6)
Time below target (< 70 mg/dL)
Compare glycemic control
Measured: at 12 months
Glycemic coefficient of variation (CV)
Compare glycemic control
Measured: at 12 months
glucose management indicator
Compare glycemic control
Measured: at 12 months
HBA1c
Compare glycemic control
Measured: at 12 months
weight daily insulin dose
Compare glycemic control
Measured: at 12 months
daily insulin dose
Compare glycemic control
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start6 Jul 2023
- Primary completion11 Jul 2024
- Study completion11 Jul 2024
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
- Retrospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Coralie AMADOU, PHD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932966
- Sponsor's protocol ID
- 2023/0024
- Acronym
- COMPARE-CLIDS
- Status last verified
- Aug 2024
- First submitted
- 21 Jun 2023
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison With Observational Methods and Performance Assessment From Real-life Experience of Closed-Loop Insulin Delivery Systems
- ClinicalTrials.gov ID
- NCT05932966
- Acronym / sponsor ID
- COMPARE-CLIDS / 2023/0024
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- diabetes type 1, closed loop insulin delivery system, continuous glucose monitoring, sensor-augmented pump
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 6 Jul 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.
This study aims to compare glycemic control obtained under closed loop depending on the system : Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1.
Detailed description
Since 2021, several closed-loop insulin delivery systems have been reimbursed in France for patients living with type 1 diabetes. The "real-life" efficacy and safety of these systems have already been the subject of several publications, confirming the results of clinical trials.
To date, there are no clinical trial comparing closed-loop systems. There are, however, a few observational studies that have attempted such a comparison, but with few patients included or a poorly adapted methodology.
Given the size of the cohort of patients with type 1 diabetes fitted with a closed-loop system in the diabetology department of the Centre Hospitalier Sud-Francilien since 2021 (> 400), we propose a single-center analysis to compare real-life performance of Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1 during a follow-up of 12 months and using a propensity score
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type 1 Diabetes equipped with control-IQ closed loop system | – | Device: Insulin closed-loop delivery systemPatients with type 1 Diabetes equipped with control-IQ closed loop system |
| Patients with type 1 diabetes equipped with Smart GUARD closed loop system | – | Device: Insulin closed-loop delivery systemPatients with type 1 diabetes equipped with Smart GUARD closed loop system |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The population will be selected from the diabetes department of a French public hospital. All eligible patients will be included in the study.
Key inclusion criteria (4 listed)
- Patient > 16 years
- Patient with diabetes type 1.
- Patient treated with a CONTROL-IQ or SMARTGUARD closed-loop insulin delivery system between 01/2021 and 05/2022.
- Follow-up patient in Centre Hospitalier Sud Francilien
Key exclusion criteria (3 listed)
- Women who had pregnancy within 12 months of system initiation.
- Patient who have been treated with both systems within 12 months.
- Patient or parental authority objecting the use of data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin closed-loop delivery systemInsulin closed-loop delivery system | Device | Patients with type 1 Diabetes equipped with control-IQ closed loop system, Patients with type 1 diabetes equipped with Smart GUARD closed loop system |
Primary outcome
Comparison of glycemic control obtained under closed loop according to the system used: SG versus CIQ
Time frame: at 12 months
Time spent in target range (between 70 and 180 mg/dL) after 12 months following initiation of the closed-loop system, as measured by continuous glucose monitoring (CGM).system, as measured by continuous glucose monitoring (CGM).
6 secondary outcomes
Time below target (< 70 mg/dL)
Time frame: at 12 months
Glycemic coefficient of variation (CV)
Time frame: at 12 months
glucose management indicator
Time frame: at 12 months
HBA1c
Time frame: at 12 months
weight daily insulin dose
Time frame: at 12 months
daily insulin dose
Time frame: at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Coralie AMADOU, PHD principal investigator
Centre Hospitalier Sud Francilien
1 site 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 Centre Hospitalier Sud Francilien at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of glycemic control obtained under closed loop according to the system used: SG versus CIQ (time frame: at 12 months). 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 15 Aug 2024.