Diabetes Mellitus Type 2 - Insulin-TreatedClose2targetNCT05369871
Evaluation of a Closed-loop System for the Treatment of Type 2 Diabetes at Home (DT2_2)
A study testing Closed-loop system and Open-loop system in people with Diabetes Mellitus Type 2 - Insulin-Treated, run by Diabeloop at 3 sites in France.
Trial summary
The objective of this clinical trial is to study the feasibility of using a closed loop and its impact on glycemic control, in patients with type 2 diabetes (T2D) treated with insulin pumps. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2 - Insulin-Treated
- What is being tested?
- Closed-loop system and Open-loop system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Aug 2022to 28 Jul 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patient > 18 years old
- Patient with a weight < 150 kg
- Patient with type 2 diabetes (T2D) treated by insulin pump for at least 6 months
- Patient with stable pharmacological treatment of diabetes for at least 6 months
- Patient equipped with a CGM or Flash Glucose Meter (FGM)
- Patient diagnosed with T2D by a diabetologist
Show all 28Show fewer
- Patient treated with a total daily dose of insulin < 160 U/24 h
- Patient with an HbA1c < 10%.
- Patient affiliated to the social security system or beneficiary of such a system
- Patient able to read and understand the procedure, and in a condition to express consent for the study protocol
- No Inclusion Criteria:
- Patient with type 1 diabetes
- Patient receiving less than 8 units of insulin per day
- Patients suffering from a serious illness or undergoing treatment that may affect the physiology of diabetes, i.e., interactions with glucose and/or insulin that may interfere with the medical device (e.g., steroid treatment)
- Patient with severe uncorrected hearing and/or visual acuity problems
- Patient not wishing to use rapid-acting insulin analog 100 U/mL
- Patient who has undergone pancreatectomy or whose pancreas is severely impaired
- Patients with severe renal impairment (clearance < 30 mL/min)
- Patient with reduced sensation of hypoglycemia
- Patient with highly unstable diabetes
- Patient who received a pancreas or islet transplant
- Patient undergoing dialysis
- Critically ill patient
- Patient with neuropathy
- Patient with retinopathy
- Patient currently participating or having participated in the month prior to inclusion in another clinical interventional research study that may have an impact on the study, this impact is left to the discretion of the investigator
- Persons referred to in articles L1121-5 to L1121-8 of the CSP: pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, persons under legal protection
- Subject who would receive more than 4500 euros in compensation due to his or her participation in other research involving the human person in the 12 months preceding this study
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CH Métropole Savoie
Chambéry, 73300
CH Annecy-Genevois
Epagny Metz-Tessy, 74374
CHU Grenoble Alpes
La Tronche, 38700
About this study
The objective of this clinical trial is to study the feasibility of using a closed loop and its impact on glycemic control, in patients with type 2 diabetes (T2D) treated with insulin pumps.
Read the detailed description
T2D is a condition that combines insulin resistance and relative insulin deficiency. T2D naturally evolves into an increasingly marked insulin deficiency that leads to the need for pancreatic replacement, by administering insulin.
Type 1 diabetes (T1D) requires an integral and immediate substitution of pancreatic insulin secretion. Artificial intelligence, through a self-learning algorithm, enables the automation and personalization of insulin delivery. These devices, called "closed loops" bring a real benefit for the patients included in the studies, by improving the glycemic balance, by reducing the number of hypo- and hyperglycemias but also by reducing the mental load associated with the disease, improving their quality of life.
The objective of this clinical trial is to study the feasibility of using a closed loop and its impact on glycemic control, in patients with T2D treated with insulin pumps.
A 13-week interventional, randomized, controlled, crossover, open-label, multicenter main study, followed by an optional, open-label, additional 4-week study is proposed to patients.
Main objective: study of the impact of the closed loop for 6 weeks, compared to 6 weeks in an open loop, on glycemic balance (evaluated by the time in range 70-180 mg/dL).
Secondary objectives: study of the impact of the closed loop for 6 weeks, compared to 6 weeks in an open loop, on:
- glycemic balance (others parameters)
- daily physical activity
- quality of sleep
- satisfaction with diabetes treatment
- quality of life
- treatment safety
Evaluation of the satisfaction of the use (usability) of the system at the end of the closed loop period.
- Being tested
- Closed-loop system, Open-loop system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop systemDevice
Closed-loop system consisting of a terminal including the Diabeloop algorithm that is associated with the Dexcom G6 CGM and the Accu-Chek Insight insulin pump.
Open-loop systemDevice
Open-loop system consisting of a terminal without the Diabeloop algorithm that is associated with the Dexcom G6 CGM and the usual insulin pump.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop system followed by open-loop system | Experimental | An interventional cross-over study:
* six weeks in closed-loop system with Accu-Chek Insight pump and continuous glucose monitoring (CGM) :consisting of 2 weeks of adaptation where data will not be collected + 4 weeks
* followed by six weeks in open-loop system with usual pump and CGM : consisting of 2 weeks of adaptation where data will not be collected + 4 weeks ,
Followed by an optional additional study: 4 weeks in closed-loop system. Receives: Device: Closed-loop system; Device: Open-loop system |
| Open-loop system followed by closed-loop system | Experimental | An interventional cross-over study:
* six weeks in open-loop system with usual pump and CGM : consisting of 2 weeks of adaptation where data will not be collected + 4 weeks
* followed by six weeks in closed-loop system with Accu-Chek Insight pump and CGM (including two weeks of adaptation) : consisting of 2 weeks of adaptation where data will not be collected + 4 weeks
Followed by an optional additional study: 4 weeks in closed-loop system. Receives: Device: Closed-loop system; Device: Open-loop system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control evaluation for the 12-week main study
Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the glycemic balance (time spent in the target 70-180 mg/dL).
The data used for the analysis are the last 4 weeks of each 6-week sequence.
Measured: Day 84
Secondary outcomes (21)
Daily glycemic variability evaluation for the 12-week main study
Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the daily glycemic variability measured by the coefficient of variation The data used for the analysis are the last 4 weeks of each 6-week sequence.
Measured: Day 84
Daily glycemic variability evaluation for the 12-week main study
Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the daily glycemic variability measured by the standard deviation.
The data used for the analysis are the last 4 weeks of each 6-week sequence.
Measured: Day 84
Daily time spent in hypoglycemia evaluation for the 12-week main study
Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the percentage of daily time spent in hypoglycemia.
The data used for the analysis are the last 4 weeks of each 6-week sequence.
Measured: Day 84
Daily time spent in hyperglycemia evaluation for the 12-week main study
Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the percentage of daily time spent in hyperglycemia.
The data used for the analysis are the last 4 weeks of each 6-week sequence.
Measured: Day 84
Daily amount of insulin administered evaluation for the 12-week main study
Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the average daily amount of insulin administered.
The data used for the analysis are the last 4 weeks of each 6-week sequence.
Measured: Day 84
Daily glucose management indicator (GMI) corresponding to the estimated HbA1c
Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the Glucose management indicator (GMI) measurement using CGM data.
The data used for the analysis are the last 4 weeks of each 6-week sequence.
Measured: Day 84
Daily physical activity evaluation for the 12-week main study
Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the daily physical activity, measured by actimetry for 7 days.
Measured: Day 84
Sleep quality evaluation for the 12-week main study
Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the sleep quality (duration and fragmentation), measured by actimetry for 7 days.
Measured: Day 84
Diabetes treatment satisfaction evaluation for the 12-week main study
Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the diabetes treatment satisfaction, measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ).
The DTSQ questionnaire is composed by a score which has a minimum of zero and a maximum of 36. The higher the score, the more satisfied the patient is with their treatment.
Measured: Days 42 and 84 (according to the randomized arm)
Quality of life questionnaire for the 12-week main study
Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the quality of life, measured by a questionnaire.
This questionnaire is composed of 10 items. For each item, there are 3 possible answers: "less well than before"; "same as before"; "better than before". A score will be calculated from the 10 items by adding 1 point for each improvement answer allowing the calculation of a score varying between 0 and 10. A high score represents a better improvement in quality of life.
Measured: Days 42 or 84 (according to the randomized arm)
Incidence of Adverse events evaluation for the 12-week main study (safety and tolerability)
Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the treatment safety, measured by the number of adverse events
Measured: Day 84
System satisfaction questionnaire evaluation
Evaluation of the closed loop system satisfaction by an usability questionnaire
This questionnaire is composed of 5 sections. Section 1 evaluates satisfaction with the use of the medical device and will be evaluated through a score varying between 10 and 50. A high score means that satisfaction with the use of the device is high.
Section 3 evaluates the ease of use of the device and will be evaluated through a score varying between 16 and 80. A high score means that the system is easy to use.
Sections 2, 4 and 5 will not be scored and will only be subject to descriptive analysis.
Measured: Days 42 or 84 (according to the randomized arm)
Glycemic control evaluation for the 4-week additional study
Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the glycemic balance (time spent in the target 70-180 mg/dL).
Measured: Day 112
Daily glycemic variability
Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the daily glycemic variability measured by the coefficient of variation
Measured: Day 112
Daily glycemic variability
Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the daily glycemic variability measured by the standard deviation
Measured: Day 112
Percentage of daily time spent in hypoglycemia
Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the daily time spent in hypoglycemia
Measured: Day 112
Percentage of daily time spent in hyperglycemia
Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the daily time spent in hyperglycemia
Measured: Day 112
Average daily amount of insulin administered
Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the average daily amount of insulin administered
Measured: Day 112
Daily glucose management indicator (GMI) corresponding to the estimated HbA1c
Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the Glucose management indicator (GMI) measurement using CGM data.
Measured: Day 112
Diabetes treatment satisfaction
Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the diabetes treatment satisfaction, measured by the Diabetes Treatment Satisfaction Questionnaire.
The DTSQ questionnaire is composed by a score which has a minimum of zero and a maximum of 36. The higher the score, the more satisfied the patient is with their treatment.
Measured: Day 112
System satisfaction questionnaire evaluation
Evaluation of the system satisfaction by an usability questionnaire
This questionnaire is composed of 5 sections. Section 1 evaluates satisfaction with the use of the medical device and will be evaluated through a score varying between 10 and 50. A high score means that satisfaction with the use of the device is high.
Section 3 evaluates the ease of use of the device and will be evaluated through a score varying between 16 and 80. A high score means that the system is easy to use.
Sections 2, 4 and 5 will not be scored and will only be subject to descriptive analysis.
Measured: Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start29 Aug 2022
- Primary completion9 May 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 - Insulin-TreatedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a 13-week interventional, randomized, controlled, crossover, open-label, multicenter main study, followed by an optional, open-label, additional 4-week study.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabeloop
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icadom, AGIR à Dom, University Hospital, Grenoble, Centre Hospitalier Annecy Genevois, Centre Hospitalier Metropole Savoie
- Responsible party
- Sponsor
- Investigators
- Anne-Laure BOREL, MD, PhD, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369871
- Sponsor's protocol ID
- RCB 2020-A03429-30
- Acronym
- Close2target
- Status last verified
- Sep 2023
- First submitted
- 6 May 2022
- Last updated
- 7 Sep 2023
- 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 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Closed-loop System for the Treatment of Type 2 Diabetes at Home (DT2_2)
- ClinicalTrials.gov ID
- NCT05369871
- Acronym / sponsor ID
- Close2target / RCB 2020-A03429-30
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- DiabeloopIndustry (pharma, biotech, devices)
- Collaborators
- Icadom, AGIR à Dom, University Hospital, Grenoble, Centre Hospitalier Annecy Genevois, Centre Hospitalier Metropole Savoie
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 11 May 2022 (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 objective of this clinical trial is to study the feasibility of using a closed loop and its impact on glycemic control, in patients with type 2 diabetes (T2D) treated with insulin pumps.
Detailed description
T2D is a condition that combines insulin resistance and relative insulin deficiency. T2D naturally evolves into an increasingly marked insulin deficiency that leads to the need for pancreatic replacement, by administering insulin.
Type 1 diabetes (T1D) requires an integral and immediate substitution of pancreatic insulin secretion. Artificial intelligence, through a self-learning algorithm, enables the automation and personalization of insulin delivery. These devices, called "closed loops" bring a real benefit for the patients included in the studies, by improving the glycemic balance, by reducing the number of hypo- and hyperglycemias but also by reducing the mental load associated with the disease, improving their quality of life.
The objective of this clinical trial is to study the feasibility of using a closed loop and its impact on glycemic control, in patients with T2D treated with insulin pumps.
A 13-week interventional, randomized, controlled, crossover, open-label, multicenter main study, followed by an optional, open-label, additional 4-week study is proposed to patients.
Main objective: study of the impact of the closed loop for 6 weeks, compared to 6 weeks in an open loop, on glycemic balance (evaluated by the time in range 70-180 mg/dL).
Secondary objectives: study of the impact of the closed loop for 6 weeks, compared to 6 weeks in an open loop, on:
- glycemic balance (others parameters)
- daily physical activity
- quality of sleep
- satisfaction with diabetes treatment
- quality of life
- treatment safety
Evaluation of the satisfaction of the use (usability) of the system at the end of the closed loop period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a 13-week interventional, randomized, controlled, crossover, open-label, multicenter main study, followed by an optional, open-label, additional 4-week study.
| Arm | Type | Receives |
|---|---|---|
| Closed-loop system followed by open-loop system | Experimental | Device: Closed-loop system, Device: Open-loop systemAn interventional cross-over study: * six weeks in closed-loop system with Accu-Chek Insight pump and continuous glucose monitoring (CGM) :consisting of 2 weeks of adaptation where data will not be collected + 4 weeks * followed by six weeks in open-loop system with usual pump and CGM : consisting of 2 weeks of adaptation where data will not be collected + 4 weeks , Followed by an optional additional study: 4 weeks in closed-loop system. |
| Open-loop system followed by closed-loop system | Experimental | Device: Closed-loop system, Device: Open-loop systemAn interventional cross-over study: * six weeks in open-loop system with usual pump and CGM : consisting of 2 weeks of adaptation where data will not be collected + 4 weeks * followed by six weeks in closed-loop system with Accu-Chek Insight pump and CGM (including two weeks of adaptation) : consisting of 2 weeks of adaptation where data will not be collected + 4 weeks Followed by an optional additional study: 4 weeks in closed-loop system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Patient > 18 years old
- Patient with a weight < 150 kg
- Patient with type 2 diabetes (T2D) treated by insulin pump for at least 6 months
- Patient with stable pharmacological treatment of diabetes for at least 6 months
- Patient equipped with a CGM or Flash Glucose Meter (FGM)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Closed-loop systemClosed-loop system consisting of a terminal including the Diabeloop algorithm that is associated with the Dexcom G6 CGM and the Accu-Chek Insight insulin pump. | Device | Closed-loop system followed by open-loop system, Open-loop system followed by closed-loop system |
| Open-loop systemOpen-loop system consisting of a terminal without the Diabeloop algorithm that is associated with the Dexcom G6 CGM and the usual insulin pump. | Device | Closed-loop system followed by open-loop system, Open-loop system followed by closed-loop system |
Primary outcome
Glycemic control evaluation for the 12-week main study
Time frame: Day 84
Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the glycemic balance (time spent in the target 70-180 mg/dL). The data used for the analysis are the last 4 weeks of each 6-week sequence.
21 secondary outcomes
Daily glycemic variability evaluation for the 12-week main study
Time frame: Day 84
Daily glycemic variability evaluation for the 12-week main study
Time frame: Day 84
Daily time spent in hypoglycemia evaluation for the 12-week main study
Time frame: Day 84
Daily time spent in hyperglycemia evaluation for the 12-week main study
Time frame: Day 84
Daily amount of insulin administered evaluation for the 12-week main study
Time frame: Day 84
Daily glucose management indicator (GMI) corresponding to the estimated HbA1c
Time frame: Day 84
Daily physical activity evaluation for the 12-week main study
Time frame: Day 84
Sleep quality evaluation for the 12-week main study
Time frame: Day 84
Diabetes treatment satisfaction evaluation for the 12-week main study
Time frame: Days 42 and 84 (according to the randomized arm)
Quality of life questionnaire for the 12-week main study
Time frame: Days 42 or 84 (according to the randomized arm)
Incidence of Adverse events evaluation for the 12-week main study (safety and tolerability)
Time frame: Day 84
System satisfaction questionnaire evaluation
Time frame: Days 42 or 84 (according to the randomized arm)
Glycemic control evaluation for the 4-week additional study
Time frame: Day 112
Daily glycemic variability
Time frame: Day 112
Daily glycemic variability
Time frame: Day 112
Percentage of daily time spent in hypoglycemia
Time frame: Day 112
Percentage of daily time spent in hyperglycemia
Time frame: Day 112
Average daily amount of insulin administered
Time frame: Day 112
Daily glucose management indicator (GMI) corresponding to the estimated HbA1c
Time frame: Day 112
Diabetes treatment satisfaction
Time frame: Day 112
System satisfaction questionnaire evaluation
Time frame: Day 112
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 7 Sep 2023.
- 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.
Anne-Laure BOREL, MD, PhD principal investigator
CHU Grenoble Alpes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-loop system and Open-loop system in people with Diabetes Mellitus Type 2 - Insulin-Treated, run by Diabeloop at 3 sites 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 28 inclusion and 0 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Glycemic control evaluation for the 12-week main study (time frame: Day 84). 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 7 Sep 2023.