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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
37
bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios)
No bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios)
CHU de Nantes
Nantes, France
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.
Time frame: 4 weeks
Coefficient of variation of glucose
Hypoglycemic readings \< 0.7 g/L, Time below 0.7 g/L, Time above 1.8 g/L
Time frame: 75 days
Frequency of severe hypoglycemia
Frequency of severe hypoglycemia (requiring the intervention of a third party)
Time frame: 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.
Time frame: 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
Time frame: 75 days
assessment of patient acceptance
Quality of life questionnaire SF36
Time frame: 75 days
the average time of medical consultation in each group.
Duration of the consultation
Time frame: 75 days
changes in heart rate over time
Time frame: 75 days
changes in activity over time
Time frame: 75 days
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