Clinical trial NCT04572009: Validation of a Biomathematical Model to Help Identify the Parameters of Flexible Insulin Therapy
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes mellitus
biomathematical model
Flexible insulin therapy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Patient with type 1 diabetes for at least two years with an indication for sensor placement,
2. Patient patient with at least 6 months of external insulin pump therapy and using the Medtronic 640G pump with or without the Enlite® System.
3. Patient having at least 6 months experience of flexible insulin therapy,
4. Patient with HbA1c \<10% (less than 4 months' duration of testing in a medical laboratory or equivalent),
5. Patient who has been wearing a Continuous Glucose Monitoring device for at least 3 months,
6. Adult patient,
7. Patient affiliated to a Social Security or equivalent,
8. Patient who has signed Informed Consent Form.

Exclusion Criteria:

1. Patient with type 2 diabetes or secondary diabetes
2. Patient with any serious medical condition that may affect participation in the study,
3. Patient benefiting from a legal protection measure,
4. 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,
5. Breastfeeding,
6. Psychological and/or physical condition that may affect the proper monitoring of study procedures,
7. Severe hypoglycemia leading to convulsions or loss of consciousness within the last 12 months,
8. Decreased hypoglycemic feelings (as judged by the clinician),
9. Impaired renal function (creatinine clearance calculated by CKD-EPI \< 30mL/min),
10. Patient who has had a pancreas transplant or pancreatic islets,
11. Persons with severe uncorrected hearing and/or visual acuity problems,
12. Insulin resistance defined by daily insulin requirements \> 1 U/kg/day in the week prior to inclusion,
13. Patient treated with oral corticosteroid therapy.

Primary outcomes:
measure: percentage of time in glycemic target
timeFrame: 4 weeks
Secondary outcomes:
measure: Coefficient of variation of glucose
timeFrame: 75 days
measure: Frequency of severe hypoglycemia
timeFrame: 75 days
measure: Robustness of the model
timeFrame: 75 days
measure: assessment of patient compliance
timeFrame: 75 days
measure: assessment of patient acceptance
timeFrame: 75 days
measure: the average time of medical consultation in each group.
timeFrame: 75 days
measure: changes in heart rate over time
timeFrame: 75 days
measure: changes in activity over time
timeFrame: 75 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Lucy CHAILLOUS, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.