Diabetes
Conditions
Interventions
The study will consist of the measurement of glucose and serum insulin levels
at baseline and following a meal. Patients with Type 1 diabetes will come in
for two blocks of visits: one block of two
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Aged 18 years or above Diagnosed with Type 1 DM at least 6 months according to the WHO definition Treated with CSII or MDII for at least 3 months Body Mass Index (BMI)
Exclusion criteria
Exclusion criteria: Patient is pregnant or breastfeeding Patient is using a medication which significantly impacts glucose metabolism, except if stable for at least 3 months Patient has a severe medical or psychological condition which, in the opinion of the investigator, prohibits participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be time to peak serum insulin levels following administration of the mealtime insulin bolus with CP and PP, and coefficient of variation (CV) of basal and postprandial insulin levels after CP and PP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will include postprandial glucose excursions, early insulin t50% and area under the curve for insulin levels, Maximum concentration of insulin levels, delta baseline to peak in insulin levels and coefficient of variation of basal insulin levels. Of the secondary endpoints listed above the same will be determined for glucose levels after administration of mealtime bolus. | — |
Countries
Netherlands
Outcome results
None listed