Type 1 Diabetes MellitusLOOPEDNCT06858475
Long-term Observation Of Patient Engagement in Automated Insulin Delivery
An observational study of Type 1 Diabetes Mellitus, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The purpose of this study is to assess the long-term evolution of patient interaction with the CONTROL-IQ (Tandem™) hybrid closed-loop (HCL) system in individuals with type 1 diabetes over 24 months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes Mellitus
- Type of treatment
- Medical device
- How many people
- 453 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2025to 30 Apr 2025
- 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 Any age
- All sexes
- No healthy volunteers
- 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
- Patients using the CONTROL-IQ hybrid closed-loop system with data uploaded to the myDiabby platform at least once between October 2021 and October 2024, affiliated with the diabetology department of CHSF.
Who cannot join
- Patients with a type of diabetes other than type 1 diabetes.
- Patients who have objected to the use of their data.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the long-term evolution of patient interaction with the CONTROL-IQ (Tandem™) hybrid closed-loop (HCL) system in individuals with type 1 diabetes over 24 months. Specifically, the study examines user-initiated boluses and carbohydrate announcements to determine whether initially low-engagement users increase their involvement over time or, conversely, whether highly engaged users gradually rely more on automation.
Read the detailed description
Automated insulin delivery (AID) systems have revolutionized type 1 diabetes (T1D) management, offering superior glycemic control and quality of life compared to sensor-augmented insulin pumps or multiple daily injections (MDI). However, current AID systems operate as hybrid closed-loop (HCL) systems, requiring user intervention for meal boluses, including carbohydrate counting and timely insulin administration.
Control-IQ (Tandem™) was the second AID system reimbursed by the French National Health Insurance and is now widely used in France. It combines the Tandem™ t:slim insulin pump with Dexcom™ G6 continuous glucose monitoring (CGM), adjusting basal insulin every five minutes based on glucose predictions and delivering automatic correction boluses once per hour. Despite these automation features, users must still manually initiate meal boluses, and additional correction boluses remain optional. While engagement in carbohydrate counting and timely meal announcements improves metabolic outcomes, real-world data suggest that AID benefits individuals across varying engagement levels.
Long-term data on patient behavior and engagement, particularly regarding carbohydrate announcements and the ratio of automatic to user-initiated boluses, remain limited. Understanding these patterns could reveal whether initially low-engagement users increase involvement over time or whether highly engaged users eventually rely more on automation.
This single-center, 24-month observational study will follow all T1D patients treated with Control-IQ at the Centre Hospitalier Sud-Francilien between October 2021 and October 2024.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- CONTROL-IQ (Tandem™)
- Keywords
- Type 1 diabetes mellitus, Automated insulin delivery, Continuous glucose monitoring, Carbohydrate counting, Meal announcement
- 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.
CONTROL-IQ (Tandem™)Device
interaction with the CONTROL-IQ (Tandem™) hybrid closed-loop (HCL) system in individuals with type 1 diabetes
| Study group | Role | What they receive |
|---|---|---|
| With device | Not described Receives: Device: CONTROL-IQ (Tandem™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of automatic boluses
To assess the 24-month evolution of the automatic-to-user-initiated bolus ratio
Measured: repeated measurement over 24 months (8 quarters)
Secondary outcomes (7)
time spent in closed-loop mode
Measurement of the quarterly evolution, over 24 months, of the percentage of time spent in closed-loop mode (CONTROL-IQ ON)
Measured: repeated measurement over 24 months (8 quarters)
insulin dose (UI)
Measurement of the quarterly evolution, over 24 months, of the average of total daily insulin dose (UI)
Measured: repeated measurement over 24 months (8 quarters)
carbohydrates
Measurement of the quarterly evolution, over 24 months, of the average amount of carbohydrates reported daily in closed-loop mode (CONTROL-IQ).
Measured: repeated measurement over 24 months (8 quarters)
glucose
Measurement of the quarterly evolution, over 24 months, of continuous glucose monitoring parameters, including average glucose in closed-loop mode (CONTROL-IQ).
Measured: Repeated measurement over 24 months (8 quarters)
glucose management indicator
Measurement of the quarterly evolution, over 24 months, of continuous glucose monitoring parameters, including average glucose management indicator in closed-loop mode (CONTROL-IQ).
Measured: Repeated measurement over 24 months (8 quarters)
glucose coefficient of variation
Measurement of the quarterly evolution, over 24 months, of continuous glucose monitoring parameters, including glucose coefficient of variation in closed-loop mode (CONTROL-IQ).
Measured: Repeated measurement over 24 months (8 quarters)
percentage of time in target range (70-180 mg/dL)
Measurement of the quarterly evolution, over 24 months, of continuous glucose monitoring parameters, including percentage of time in target range (70-180 mg/dL) in closed-loop mode (CONTROL-IQ).
Measured: Repeated measurement over 24 months (8 quarters)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start20 Mar 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Coralie AMADOU, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858475
- Sponsor's protocol ID
- 2025/0001
- Acronym
- LOOPED
- Status last verified
- Jun 2025
- First submitted
- 21 Feb 2025
- Last updated
- 20 Jun 2025
- 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 20 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Observation Of Patient Engagement in Automated Insulin Delivery
- ClinicalTrials.gov ID
- NCT06858475
- Acronym / sponsor ID
- LOOPED / 2025/0001
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes mellitus, Automated insulin delivery, Continuous glucose monitoring, Carbohydrate counting, Meal announcement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 5 Mar 2025 (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.
The purpose of this study is to assess the long-term evolution of patient interaction with the CONTROL-IQ (Tandem™) hybrid closed-loop (HCL) system in individuals with type 1 diabetes over 24 months. Specifically, the study examines user-initiated boluses and carbohydrate announcements to determine whether initially low-engagement users increase their involvement over time or, conversely, whether highly engaged users gradually rely more on automation.
Detailed description
Automated insulin delivery (AID) systems have revolutionized type 1 diabetes (T1D) management, offering superior glycemic control and quality of life compared to sensor-augmented insulin pumps or multiple daily injections (MDI). However, current AID systems operate as hybrid closed-loop (HCL) systems, requiring user intervention for meal boluses, including carbohydrate counting and timely insulin administration.
Control-IQ (Tandem™) was the second AID system reimbursed by the French National Health Insurance and is now widely used in France. It combines the Tandem™ t:slim insulin pump with Dexcom™ G6 continuous glucose monitoring (CGM), adjusting basal insulin every five minutes based on glucose predictions and delivering automatic correction boluses once per hour. Despite these automation features, users must still manually initiate meal boluses, and additional correction boluses remain optional. While engagement in carbohydrate counting and timely meal announcements improves metabolic outcomes, real-world data suggest that AID benefits individuals across varying engagement levels.
Long-term data on patient behavior and engagement, particularly regarding carbohydrate announcements and the ratio of automatic to user-initiated boluses, remain limited. Understanding these patterns could reveal whether initially low-engagement users increase involvement over time or whether highly engaged users eventually rely more on automation.
This single-center, 24-month observational study will follow all T1D patients treated with Control-IQ at the Centre Hospitalier Sud-Francilien between October 2021 and October 2024.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| With device | – | Device: CONTROL-IQ (Tandem™) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- 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 (1 listed)
- Patients using the CONTROL-IQ hybrid closed-loop system with data uploaded to the myDiabby platform at least once between October 2021 and October 2024, affiliated with the diabetology department of CHSF.
Key exclusion criteria (2 listed)
- Patients with a type of diabetes other than type 1 diabetes.
- Patients who have objected to the use of their 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 |
|---|---|---|
| CONTROL-IQ (Tandem™)interaction with the CONTROL-IQ (Tandem™) hybrid closed-loop (HCL) system in individuals with type 1 diabetes | Device | With device |
Primary outcome
number of automatic boluses
Time frame: repeated measurement over 24 months (8 quarters)
To assess the 24-month evolution of the automatic-to-user-initiated bolus ratio
7 secondary outcomes
time spent in closed-loop mode
Time frame: repeated measurement over 24 months (8 quarters)
insulin dose (UI)
Time frame: repeated measurement over 24 months (8 quarters)
carbohydrates
Time frame: repeated measurement over 24 months (8 quarters)
glucose
Time frame: Repeated measurement over 24 months (8 quarters)
glucose management indicator
Time frame: Repeated measurement over 24 months (8 quarters)
glucose coefficient of variation
Time frame: Repeated measurement over 24 months (8 quarters)
percentage of time in target range (70-180 mg/dL)
Time frame: Repeated measurement over 24 months (8 quarters)
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 20 Jun 2025.
- 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, MD 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 Type 1 Diabetes Mellitus, 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 1 inclusion and 2 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 20 Jun 2025. 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?
number of automatic boluses (time frame: repeated measurement over 24 months (8 quarters)). 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 20 Jun 2025.