Validation of a Biomathematical Model to Help Identify the Parameters of Flexible Insulin Therapy

NCT ID: NCT04572009

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-12
• Study Completion Date: 2022-10-04

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Augmented physician

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.

Group Type: EXPERIMENTAL

Bio-mathematical model

Intervention Type: OTHER

bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios)

Control

Unassisted medical decision to define the parameters of flexible insulin therapy based on data from a continuous glucose measurement record.

Group Type: PLACEBO_COMPARATOR

Without bio-mathematical model

Intervention Type: OTHER

No bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios)

Interventions

Bio-mathematical model

bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios)

Intervention Type: OTHER

Without bio-mathematical model

No bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucy CHAILLOUS, Dr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

CHU de Nantes

Nantes, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35577814 (View on PubMed)

Other Identifiers

RC20_0278

Identifier Type: -

Identifier Source: org_study_id