Diabetes Mellitus Type 1 Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus
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 vi
Sponsors
Academic Medical Centre (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above 2. Diagnosed with Type 1 diabetes mellitus (DM) at least 6 months according to the WHO definition 3. Treated with CSII or MDII for at least 3 months 4. Body Mass Index (BMI) <35 kg/m² 5. Willing and able to wear the study pump devices for the duration of the study and undergo all study procedures 6. Willing to use insulin lispro for the duration of the trial 7. HbA1c measured during the last three months between 6 and 10% 8. Signed informed consent form prior to study entry 9. Using <66 insulin units per day on average
Exclusion criteria
Exclusion criteria: 1. Patient is pregnant, or breast feeding during the period of the study 2. Patient is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration 3. Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the patient?s safety or successful participation in the study 4. Patient is actively enrolled in another clinical trial or took part in a study within the past 30 days 5. Known adrenal gland problem, pancreatic tumour, or insulinoma 6. Inability of the patient to comply with all study procedures 7. Inability of the patient to understand the patient information 8. Patient donated blood in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to peak serum insulin levels following administration of the mealtime insulin bolus with CP and PP 2. Coefficient of variation (CV) of basal and postprandial insulin levels after CP and PP. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Postprandial glucose excursions 2. Early insulin t50% and area under the curve for insulin levels 3. Maximum concentration of insulin levels 4. Delta baseline to peak in insulin levels and coefficient of variation of basal insulin levels 5. Glucose levels and the outcomes listed above for insulin will also be calculated for glucose values after administration of mealtime bolus. | — |
Countries
France, Germany, Italy, Netherlands
Outcome results
None listed