Optimal time of mealtime insulin administration in people with type 1 diabetes
- Conditions
- Type 1 diabetes and postprandial glycemic conditions.Nutritional, Metabolic, EndocrineInsulin-dependent diabetes mellitus
- Registration Number
- ISRCTN13984129
- Lead Sponsor
- Academic Medical Centre (AMC) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
1. Men or women aged from 18 to 75 years
2. Type 1 diabetes according to the WHO definition
3. Treated with insulin for at least 2 years and by Continuous Subcutaneous Insulin Infusion (CSII) for at least 6 months
4. Body mass index (BMI) < 35 kg/m2
5. Written informed consent
1. Pregnancy (women of childbearing potential must have an adequate contraception) or
breastfeeding
2. Treatment with systemic corticosteroids
3. Treatment with oral antidiabetics within 1 week prior to the first study day
4. Impaired renal function as shown by serum creatinine = 133 umol/l in men or = 124 umol/l in women
5. Known impaired hepatic function defined as alanine aminotransferase (ALAT) and / or aspartamine aminotransferase (ASAT) three times greater the upper limit of the normal range
6. Alcohol or drug abuse in the last year
7. Mental condition rendering the patient unable to understand the nature and scope of the
study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All outcomes in this study are outcomes derived from the postprandial glucose curve, and as such are a measure of postprandial glucose control on the three study days until 5 hours postprandially.
- Secondary Outcome Measures
Name Time Method 1. Continuous Glucose Monitoring (CGM) values<br>2. Number and duration of hypoglycemias<br>3. Maximum swing of blood-glucose levels<br>4. Highest blood glucose levels<br>5. Lowest blood glucose levels<br>6. Time spent in hyperglycemia