Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: age = 18 years heterogeneous sex (women and men), duration of diabetes = 1 year, using multiple daily injections (MDI) for a least 3 months, HbA1c result (less than 2 months) = 12% (108 mmol/mol).
Exclusion criteria
Exclusion criteria: presence of clinically significant microvascular complications: nephropathy (glomerular filtration rate <40 ml/min), neuropathy (gastroparesis specifically), or proliferative retinopathy, recent macrovascular events (<3 months), anemia or other abnormal blood test results, pregnancy, recent severe hypoglycemia (<2 weeks) , a medical situation that could interfere with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in plasma glucose levels during exercise (difference between glucose levels at the beginning of the exercise and the lowest glucose levels from the start of the exercise until the end of exercise). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary comparisons and endpoints For the exercise period only: 1) Percentage of time of plasma glucose levels spent below 4 mmol/L; 2) Decremental area under the curve (AUC) of plasma glucose levels; 3) AUC of plasma glucose levels 10 mmol/L; 8) Percentage of time of plasma glucose levels spent in target defined as between 4-10 mmol/L; 9) Mean time (minutes) to the first hypoglycemic event during the exercise period; 10) Amount of CHO needed to treat a hypoglycemic event. 11) Muscle vasodilatation. For the post-exercise period: 1) In the 4 hours following the exercise: a. Percentage of time of sensor glucose levels spent between 4 and 10 mmol/L; b. Percentage of time of sensor glucose levels spent 10 mmol/L; d. AUC of sensor glucose levels 10 mmol/L; d. AUC of sensor glucose levels < 4 mmol/L; e. Number of patients requiring an oral treatment for hypoglycemia; f. Total number of hypoglycemia episodes requiring treatment; | — |
Countries
Tunisia
Contacts
MSC