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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | Placebo Comparator | Unassisted medical decision to define the parameters of flexible insulin therapy based on data from a continuous glucose measurement record. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-mathematical model | Other | bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of variation of glucose | Hypoglycemic readings < 0.7 g/L, Time below 0.7 g/L, Time above 1.8 g/L | 75 days |
| Frequency of severe hypoglycemia | Frequency of severe hypoglycemia (requiring the intervention of a third party) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucy CHAILLOUS, Dr | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | 44093 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35577814 | Derived | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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) |
|
| 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. | 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 | 75 days |
| assessment of patient acceptance | Quality of life questionnaire SF36 | 75 days |
| the average time of medical consultation in each group. | Duration of the consultation | 75 days |
| changes in heart rate over time | 75 days |
| changes in activity over time | 75 days |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |