NCT04572009

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2021-01-12
• Primary completion: 2022-10-04
• Completion: 2022-10-04
• First posted: 2020-10-01
• Last updated: 2022-10-21

Locations

1 site across 1 country: France