Type 2 Diabetes Treated With InsulinDT2_1NCT04522882
Clinical Data Collection for the Closed Loop Development for the Type 2 Diabetes Treatment - DT2_1
A study testing Actimetry, Questionnaires and Glucose level and insulin administration in people with Type 2 Diabetes Treated With Insulin, run by Diabeloop at 1 site in France.
Trial summary
The objective of this study is to collect the evolution of blood glucose levels in type 2 diabetes (T2D) patients under different conditions of their daily life: physical activity, meals, sleep, etc. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin
- What is being tested?
- Actimetry, Questionnaires and Glucose level and insulin administration
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2020to 31 Dec 2020
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with T2D treated with insulin pump for at least 6 months
- Patient with a body mass index (BMI) between 27 and 40 kg/m2
- Patient treated with a total daily dose of insulin between 40 and 300 U/24 h
- Patient with CGM
- Patient with Social security or beneficiary
- Patient able to read and understand the procedure, and able to express consent for the study protocol
Who cannot join
- Patient with T1D
- Patient currently participating or having participated in the month prior to inclusion in another interventional clinical research that may impact the study, this impact is left to the investigator's discretion
- Persons referred to in articles L.1121-5 to L.1121-8 of the CSP (corresponds to all the protected persons: pregnant woman (checked by the dosage of β-human chorionic gonadotropin for any woman wishing to participate in the protocol and in childbearing age 60 years), parturient, mother breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Closed Loop for the Treatment of Type 2 Diabetes: Collection of Clinical Data at Home for the Creation of an Algorithmic Laboratory Test Bench
The objective of this study is to collect the evolution of blood glucose levels in type 2 diabetes (T2D) patients under different conditions of their daily life: physical activity, meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant T2D using a closed loop.
Read the detailed description
T2D is a condition that combines insulin resistance and relative insulin deficiency. The T2D naturally progresses towards an increasingly pronounced insulin deficiency that leads to the need for pancreatic replacement, by administering insulin.
Type 1 diabetes (T1D) requires a complete and immediate substitution of pancreatic insulin secretion. Currently, patients need to be involved in managing their disease by deciding how much insulin to administer based on the results of glucose monitoring. Artificial intelligence, thanks to a self-learning algorithm, enables the automation and customization of insulin administration. These devices, known as closed loops, bring real benefit to the patients included in the studies, by improving glycemic balance, by decreasing the number of hypo- and hyperglycemia but also by decreasing the mental load associated with the disease, improving their quality of life.
These very significant benefits in the T1D treatment open the possibility of obtaining similar benefits in the T2D treated by the basal-bolus type insulin regimen. This study aims to develop a specific algorithm of T2D to meet its particular characteristics.
The objective of this study is to collect the evolution of blood glucose levels in T2D patients under different conditions of their daily life: physical activity, meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant T2D using a closed loop.
- Conditions
- Type 2 Diabetes Treated With Insulin
- Being tested
- Actimetry, Questionnaires, Glucose level and insulin administration
- Keywords
- Type 2 diabetes, Insulin, Life conditions, Algorithm, Closed loop
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActimetryDevice
Actimetry will be performed at home to measure physical activity, sleep duration and patient chronotype for 7 days.
QuestionnairesOther
Patients will complete food and medication intake questionnaires for 7 days.
Glucose level and insulin administrationOther
Continuous subcutaneous glucose level (measured by continuous glucose monitor (CGM)) and the insulin doses delivered by the insulin pump will be collected for 7 days .
| Study group | Role | What they receive |
|---|---|---|
| At home clinical data collection | Experimental | Clinical data will be collected during 7 days: physical activity, sleep duration, chronotype, food and medication intake, glucose level and insulin administration. Receives: Device: Actimetry; Other: Questionnaires; Other: Glucose level and insulin administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose level modification
Continuous subcutaneous glucose level (measured by continuous glucose sensor (CGM)) for 7 days, compared to the daily activities collected and the insulin doses delivered by the insulin pump.
Measured: 7 days
Secondary outcomes (8)
Physical activity
Measured by actimetry
Measured: 7 days
Physical activity
Measured by physical actimetry journal
Measured: 7 days
Sleep duration
Measured by actimetry
Measured: 7 days
Sleep duration
Measured by sleep journal
Measured: 7 days
Patient's chronotype
Measured by actimetry
Measured: 7 days
Patient's chronotype
Measured by sleep journal
Measured: 7 days
Schedule and type of food intake
Questionnaire on schedule and type of food intake (without score on a scale)
Measured: 7 days
Medication intake
Questionnaire on medication intake (without score on a scale)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start9 Sep 2020
- Primary completion6 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Treated With InsulinStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Actimetry is performed in all patients included.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabeloop
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icadom, AGIR à Dom, CHU Grenoble Alpes
- Responsible party
- Sponsor
- Investigators
- Anne-Laure BOREL, MD, PhD, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522882
- Sponsor's protocol ID
- RCB 2020-A01710-39
- Acronym
- DT2_1
- Status last verified
- Sep 2020
- First submitted
- 23 Jul 2020
- Last updated
- 11 Jun 2021
- 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 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Closed Loop for the Treatment of Type 2 Diabetes: Collection of Clinical Data at Home for the Creation of an Algorithmic Laboratory Test Bench
- ClinicalTrials.gov ID
- NCT04522882
- Acronym / sponsor ID
- DT2_1 / RCB 2020-A01710-39
- Conditions
- Type 2 Diabetes Treated With Insulin
- Keywords
- Type 2 diabetes, Insulin, Life conditions, Algorithm, Closed loop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- DiabeloopIndustry (pharma, biotech, devices)
- Collaborators
- Icadom, AGIR à Dom, CHU Grenoble Alpes
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Aug 2020 (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 study is to collect the evolution of blood glucose levels in type 2 diabetes (T2D) patients under different conditions of their daily life: physical activity, meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant T2D using a closed loop.
Detailed description
T2D is a condition that combines insulin resistance and relative insulin deficiency. The T2D naturally progresses towards an increasingly pronounced insulin deficiency that leads to the need for pancreatic replacement, by administering insulin.
Type 1 diabetes (T1D) requires a complete and immediate substitution of pancreatic insulin secretion. Currently, patients need to be involved in managing their disease by deciding how much insulin to administer based on the results of glucose monitoring. Artificial intelligence, thanks to a self-learning algorithm, enables the automation and customization of insulin administration. These devices, known as closed loops, bring real benefit to the patients included in the studies, by improving glycemic balance, by decreasing the number of hypo- and hyperglycemia but also by decreasing the mental load associated with the disease, improving their quality of life.
These very significant benefits in the T1D treatment open the possibility of obtaining similar benefits in the T2D treated by the basal-bolus type insulin regimen. This study aims to develop a specific algorithm of T2D to meet its particular characteristics.
The objective of this study is to collect the evolution of blood glucose levels in T2D patients under different conditions of their daily life: physical activity, meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant T2D using a closed loop.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Actimetry is performed in all patients included.
| Arm | Type | Receives |
|---|---|---|
| At home clinical data collection | Experimental | Device: Actimetry, Other: Questionnaires, Other: Glucose level and insulin administrationClinical data will be collected during 7 days: physical activity, sleep duration, chronotype, food and medication intake, glucose level and insulin administration. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with T2D treated with insulin pump for at least 6 months
- Patient with a body mass index (BMI) between 27 and 40 kg/m2
- Patient treated with a total daily dose of insulin between 40 and 300 U/24 h
- Patient with CGM
- Patient with Social security or beneficiary
Key exclusion criteria (3 listed)
- Patient with T1D
- Patient currently participating or having participated in the month prior to inclusion in another interventional clinical research that may impact the study, this impact is left to the investigator's discretion
- Persons referred to in articles L.1121-5 to L.1121-8 of the CSP (corresponds to all the protected persons: pregnant woman (checked by the dosage of β-human chorionic gonadotropin for any woman wishing to participate in the protocol and in childbearing age 60 years), parturient, mother breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)
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 |
|---|---|---|
| ActimetryActimetry will be performed at home to measure physical activity, sleep duration and patient chronotype for 7 days. | Device | At home clinical data collection |
| QuestionnairesPatients will complete food and medication intake questionnaires for 7 days. | Other | At home clinical data collection |
| Glucose level and insulin administrationContinuous subcutaneous glucose level (measured by continuous glucose monitor (CGM)) and the insulin doses delivered by the insulin pump will be collected for 7 days . | Other | At home clinical data collection |
Primary outcome
Glucose level modification
Time frame: 7 days
Continuous subcutaneous glucose level (measured by continuous glucose sensor (CGM)) for 7 days, compared to the daily activities collected and the insulin doses delivered by the insulin pump.
8 secondary outcomes
Physical activity
Time frame: 7 days
Physical activity
Time frame: 7 days
Sleep duration
Time frame: 7 days
Sleep duration
Time frame: 7 days
Patient's chronotype
Time frame: 7 days
Patient's chronotype
Time frame: 7 days
Schedule and type of food intake
Time frame: 7 days
Medication intake
Time frame: 7 days
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 11 Jun 2021.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actimetry, Questionnaires and Glucose level and insulin administration in people with Type 2 Diabetes Treated With Insulin, run by Diabeloop 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 6 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 11 Jun 2021. 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?
Glucose level modification (time frame: 7 days). 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 11 Jun 2021.