diabetes type 1 Artificial pancreas closed loop glucagon kunstalvleesklier
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diabetes mellitus type 1 treated with CSII for a minimum of 6 months; 2. Age: 18-75; 3. Willing and able to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. BMI > 35 kg/m2; 2. HbA1c > 11.0%; 3. Use of heparin, coumarin derivatives or oral corticosteroids; 4. Skin condition prohibiting needle insertion; 5. Pregnancy and/or breastfeeding; 6. Any condition that the local investigator feels would interfere with trial participation or the evaluation of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Difference in postprandial and post exercise venous glucose excursions measured as area under the curve comparing closed loop format to usual care; 2. Difference in postprandial and post exercise sensor glucose excursions measured as area under the curve comparing closed loop format to usual care. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in the proportion of time spent in euglycaemia (glucose 4.0 – 7.0 mmol/l) comparing the closed loop format to usual care; 2. Difference in numbers of hypoglycaemias (glucose at or below 3.9 mmol/l) comparing the closed loop format to usual care. | — |
Contacts
AMC Amsterdam Meibergdreef 9