Diabetes type1 Clinical Trial
Official title:
Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial.
This is a randomized, cross-over study. The aim of this study is to compare the
post-prandial glycaemic variability after pure protein meal following with an administration
of square-wave bolus of meal-insulin or without any meal-insulin bolus on the other day.
Prolonged post-prandial glycaemic variability will be identified using the self-monitoring
of blood glucose (10-point curve) and CGMS.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | August 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 18 Years |
Eligibility |
Inclusion Criteria: - duration of type 1 diabetes longer than 12 months - insulin pump therapy longer than 3 months - written informed consent by patients and parents - insulin requirement more than 0,5 units/kg/day Exclusion Criteria: - diabetes related complications (e.g. nephropathy) - chronic kidney diseases - any disease judged by the investigator to affect the trial - withdrawal of consent to participate in the study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Poland | Medical University | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 30 minutes after the meal | Yes |
Primary | Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 60 minutes after the meal | Yes |
Primary | Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 90 minutes after the meal | Yes |
Primary | Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 120 minutes after the meal | Yes |
Primary | Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 150 minutes after the meal | Yes |
Primary | Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 180 minutes after the meal | Yes |
Primary | Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 210 minutes after the meal | Yes |
Primary | Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 240 minutes after the meal | Yes |
Primary | Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 270 minutes after the meal | Yes |
Primary | Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 300 minutes after the meal | Yes |
Secondary | Hypoglycemia episodes | Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms | 5-hour study period | Yes |
Secondary | Glucose Area Under the Curve (AUC) | Measurements based on CGMS | 5-hour study period | Yes |
Secondary | Mean amplitude of glycemic excursion | measurements based on SMBG | 5-hour study period | Yes |
Secondary | The difference between the maximum and baseline glucose level | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 5-hour study period | Yes |
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