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

NCT04572009 | Completed

• 1 other identifier: RC20_0278
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes mellitus; biomathematical model; Flexible insulin therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (8)

• Coefficient of variation of glucose

  75 days

• Frequency of severe hypoglycemia

  75 days

• Robustness of the model

  75 days

• assessment of patient compliance

  75 days

• assessment of patient acceptance

  75 days

Study Arms (2)

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.

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.

Other: Without bio-mathematical model

Interventions

Bio-mathematical model OTHER

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

Augmented physician

Without bio-mathematical model OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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,
• Patient treated with oral corticosteroid therapy.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

Related Publications (1)

• 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.

  PMID: 35577814 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lucy CHAILLOUS, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 1, 2020
• Study Start: January 12, 2021
• Primary Completion: October 4, 2022
• Study Completion: October 4, 2022
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

FR (1)