Type 1 diabetes mellitus
Conditions
Interventions
Product Name: fast acting insulin to be used in an insulin pump
Pharmaceutical Form: Solution for injection in cartridge
INN or Proposed INN: INSULIN GLULISINE
Sponsors
Forschungsinstitut der Diabetes-Akademie Bad Mergentheim e.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type 1 Diabetes mellitus Treatment with an insulin pump regimen (CSII) Age = 18 years to = 70 years German speaking Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: Severe general diseases or bedriddenness Anamnestic known severe psychiatric disorder according to ICD-10 (e.g., dementia, schizophrenia, eating disorder) Patients with a known history of gastroenterology disorder (such as ulcerative colitis, Crohn's disease, celiac disease, or functional disorders such as functional dyspepsia, irritable bowel syndrome) Restricted renal function (Creatinin-Clearance / GFR < 60 ml/min) Heart attack, stroke / TIA or vascular surgery within the past 6 months Severe retinopathy with the need for laser coagulation (still outstanding) Ingestion of systemic steroids Known allergy to patch For women: Pregnancy or lactation Person dependent on the sponsor or clinical investigator Limited legal capacity or legal assistance Participation in other clinical trials with - approved or not authorized - medicinal products or medical devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this experimental study the effect of different algorithms for the calculation of the prandial insulin dose on the postprandial glucose control will be be examined. An algorithm taking into account only the carbohydrate content of the meal (standard treatment in type 1 diabetes) will be tested against two algorithms takeing into account the fat and protein content of the meal (consideration of fat-protein units). The glucose development is monitored continuously by means of an interstitial glucose monitoring (FGM). The aim is to investigate with which rule for calculation of the prandial insulin dose a better postprandial glucose control can be achieved, with a continuous avoidance of postprandial hyperglycemic peaks and hypoglycemic events. ;Secondary Objective: Not applicable;Primary end point(s): Primary study outcome is the percentage of glucose values in the target range of 70 to 180 mg / dl ("time in range") over a period of 8 hours after taking a standardized test meal.;Timepoint(s) of evaluation of this end point: Continuous interstitial glucose measurement over a period of eight hours after the start of the test meal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): the percentage of glucose values below 70 and above 180 mg/dl, respectively, in the period of 8 hours after the test meal, the area under the curve of glucose over 8 hours after taking the test meal time, the occurrence of hypoglycemias or hyperglycemias requiring treatment (necessity of hypoglycemia treatment or the administration of additional correction insulin). ;Timepoint(s) of evaluation of this end point: Continuous interstitial glucose measurement over a period of eight hours after the start of the test meal. | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Thomas Haak
Diabetes-Akademie Bad Mergentheim e.V.
Outcome results
None listed