Type 1 DiabetesModIFNCT04572009
Validation of a Biomathematical Model to Help Identify the Parameters of Flexible Insulin Therapy
A study testing Bio-mathematical model and Without bio-mathematical model in people with Type 1 Diabetes, run by Nantes University Hospital at 1 site in France.
Trial summary
Type 1 diabetes is an autoimmune disease that requires daily treatment with insulin. The use of subcutaneous pumps for continuous insulin delivery has been an important advance for diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Bio-mathematical model and Without bio-mathematical model
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2021to 4 Oct 2022
- 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 with type 1 diabetes for at least two years with an indication for sensor placement,
- Patient patient with at least 6 months of external insulin pump therapy and using the Medtronic 640G pump with or without the Enlite® System.
- Patient having at least 6 months experience of flexible insulin therapy,
- Patient with HbA1c <10% (less than 4 months' duration of testing in a medical laboratory or equivalent),
- Patient who has been wearing a Continuous Glucose Monitoring device for at least 3 months,
- Adult patient,
- Patient affiliated to a Social Security or equivalent,
- Patient who has signed Informed Consent Form.
Who cannot join
- Patient with type 2 diabetes or secondary diabetes
- Patient with any serious medical condition that may affect participation in the study,
- Patient benefiting from a legal protection measure,
- Woman who is pregnant or likely to become pregnant during the course of the study, i.e., a lack of effective contraception in women of childbearing age,
- Breastfeeding,
- Psychological and/or physical condition that may affect the proper monitoring of study procedures,
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- Severe hypoglycemia leading to convulsions or loss of consciousness within the last 12 months,
- Decreased hypoglycemic feelings (as judged by the clinician),
- Impaired renal function (creatinine clearance calculated by CKD-EPI < 30mL/min),
- Patient who has had a pancreas transplant or pancreatic islets,
- Persons with severe uncorrected hearing and/or visual acuity problems,
- Insulin resistance defined by daily insulin requirements > 1 U/kg/day in the week prior to inclusion,
- Patient treated with oral corticosteroid therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Biomathematical Model to Help Identify the Parameters of Flexible Insulin Therapy: Monocentric, Controlled, Randomized and Prospective Pilot Clinical Study in Patients With Type 1 Diabetes.
Type 1 diabetes is an autoimmune disease that requires daily treatment with insulin. The use of subcutaneous pumps for continuous insulin delivery has been an important advance for diabetic patients. The evolution of technologies through the miniaturization of insulin pumps and the advent of continuous glucose sensors has made it possible to understand the development of the artificial pancreas. Several teams are working on the development of an artificial pancreas with considerable progress in closed-loop insulin delivery, particularly during the night.
The Laboratory of Digital Sciences of Nantes has developed a new bio-mathematical model describing the glucose-insulin dynamics, closer to the physiological reality of patients with type 1 diabetes. This model allows firstly to identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios).
The objective of this study is to test the relevance of this bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios).
Read the detailed description
This is an open randomized pilot clinical study, comparing the effectiveness of medical decision assisted by this bio-mathematical model ("augmented physician") versus unassisted medical decision, to define the parameters of flexible insulin therapy based on data from a continuous glucose measurement record for 7 days.
- Conditions
- Type 1 Diabetes
- Being tested
- Bio-mathematical model, Without bio-mathematical model
- Keywords
- Type 1 diabetes mellitus, biomathematical model, Flexible insulin therapy
- 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.
Bio-mathematical modelOther
bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios)
Without bio-mathematical modelOther
No bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios)
| Study group | Role | What they receive |
|---|---|---|
| Augmented physician | Experimental | Medical decision assisted by the bio-mathematical model to define the parameters of flexible insulin therapy based on data from a continuous glucose measurement record. Receives: Other: Bio-mathematical model |
| Control | Placebo comparator | Unassisted medical decision to define the parameters of flexible insulin therapy based on data from a continuous glucose measurement record. Receives: Other: Without bio-mathematical model |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of time in glycemic target
percentage of time in glycemic target (70-180 mg/dL) during the four weeks following medical consultation where the parameters of flexible insulin therapy are estimated by the physician, either conventionally or with the help of the bio-mathematical model, and parameterized in the insulin pump.
Measured: 4 weeks
Secondary outcomes (8)
Coefficient of variation of glucose
Hypoglycemic readings < 0.7 g/L, Time below 0.7 g/L, Time above 1.8 g/L
Measured: 75 days
Frequency of severe hypoglycemia
Frequency of severe hypoglycemia (requiring the intervention of a third party)
Measured: 75 days
Robustness of the model
for each glycemic holter, identification of the model from the first 3 days of recording and comparison during the last 3 days of the predicted results with the observed glucose levels. And comparison, in the "delayed modelling" arm, of the doses estimated by the diabetologist and the doses estimated from the model.
Measured: 75 days
assessment of patient compliance
evaluation of the difference between the theoretical doses recommended following modelling and the actual doses given by the patient
Measured: 75 days
assessment of patient acceptance
Quality of life questionnaire SF36
Measured: 75 days
the average time of medical consultation in each group.
Duration of the consultation
Measured: 75 days
changes in heart rate over time
Measured: 75 days
changes in activity over time
Measured: 75 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start12 Jan 2021
- Primary completion4 Oct 2022
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucy CHAILLOUS, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572009
- Sponsor's protocol ID
- RC20_0278
- Acronym
- ModIF
- Status last verified
- Oct 2022
- First submitted
- 22 Sep 2020
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scharbarg E, Greck J, Le Carpentier E, Chaillous L, Moog CH. A metamodel-based flexible insulin therapy for type 1 diabetes patients subjected to aerobic physical activity. Sci Rep. 2022 May 16;12(1):8017. doi: 10.1038/s41598-022-11772-x.
PubMed 35577814
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Biomathematical Model to Help Identify the Parameters of Flexible Insulin Therapy: Monocentric, Controlled, Randomized and Prospective Pilot Clinical Study in Patients With Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT04572009
- Acronym / sponsor ID
- ModIF / RC20_0278
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes mellitus, biomathematical model, Flexible insulin therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 1 Oct 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.
Type 1 diabetes is an autoimmune disease that requires daily treatment with insulin. The use of subcutaneous pumps for continuous insulin delivery has been an important advance for diabetic patients. The evolution of technologies through the miniaturization of insulin pumps and the advent of continuous glucose sensors has made it possible to understand the development of the artificial pancreas. Several teams are working on the development of an artificial pancreas with considerable progress in closed-loop insulin delivery, particularly during the night.
The Laboratory of Digital Sciences of Nantes has developed a new bio-mathematical model describing the glucose-insulin dynamics, closer to the physiological reality of patients with type 1 diabetes. This model allows firstly to identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios).
The objective of this study is to test the relevance of this bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios).
Detailed description
This is an open randomized pilot clinical study, comparing the effectiveness of medical decision assisted by this bio-mathematical model ("augmented physician") versus unassisted medical decision, to define the parameters of flexible insulin therapy based on data from a continuous glucose measurement record for 7 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented physician | Experimental | Other: Bio-mathematical modelMedical decision assisted by the bio-mathematical model to define the parameters of flexible insulin therapy based on data from a continuous glucose measurement record. |
| Control | Placebo comparator | Other: Without bio-mathematical modelUnassisted medical decision to define the parameters of flexible insulin therapy based on data from a continuous glucose measurement record. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with type 1 diabetes for at least two years with an indication for sensor placement,
- Patient patient with at least 6 months of external insulin pump therapy and using the Medtronic 640G pump with or without the Enlite® System.
- Patient having at least 6 months experience of flexible insulin therapy,
- Patient with HbA1c <10% (less than 4 months' duration of testing in a medical laboratory or equivalent),
- Patient who has been wearing a Continuous Glucose Monitoring device for at least 3 months,
Key exclusion criteria (13 listed)
- Patient with type 2 diabetes or secondary diabetes
- Patient with any serious medical condition that may affect participation in the study,
- Patient benefiting from a legal protection measure,
- Woman who is pregnant or likely to become pregnant during the course of the study, i.e., a lack of effective contraception in women of childbearing age,
- Breastfeeding,
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 |
|---|---|---|
| Bio-mathematical modelbio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios) | Other | Augmented physician |
| Without bio-mathematical modelNo bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios) | Other | Control |
Primary outcome
percentage of time in glycemic target
Time frame: 4 weeks
percentage of time in glycemic target (70-180 mg/dL) during the four weeks following medical consultation where the parameters of flexible insulin therapy are estimated by the physician, either conventionally or with the help of the bio-mathematical model, and parameterized in the insulin pump.
8 secondary outcomes
Coefficient of variation of glucose
Time frame: 75 days
Frequency of severe hypoglycemia
Time frame: 75 days
Robustness of the model
Time frame: 75 days
assessment of patient compliance
Time frame: 75 days
assessment of patient acceptance
Time frame: 75 days
the average time of medical consultation in each group.
Time frame: 75 days
changes in heart rate over time
Time frame: 75 days
changes in activity over time
Time frame: 75 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 14 Sep 2026.
- Results publication: PubMed 35577814Scharbarg E, Greck J, Le Carpentier E, Chaillous L, Moog CH. A metamodel-based flexible insulin therapy for type 1 diabetes patients subjected to aerobic physical activity. Sci Rep. 2022 May 16;12(1):8017. doi: 10.1038/s41598-022-11772-x.
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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.
Lucy CHAILLOUS, Dr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-mathematical model and Without bio-mathematical model in people with Type 1 Diabetes, run by Nantes University Hospital 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 8 inclusion and 13 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 14 Sep 2026. 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. Some participants in this study may receive a placebo. 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?
percentage of time in glycemic target (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04572009, which also lists 1 linked publication.
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 14 Sep 2026.