Diabetes mellitus type 1
Conditions
Interventions
Trade Name: Humalog
Product Name: Humalog Insulin Lispro
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133107-64-9
Concentration unit: IU/ml international
Sponsors
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klin. Abt. für Endokrinologie und Stoffwechsel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent obtained after being advised of the nature of the study • Male or female aged 18 to 75 years (both inclusive) • The subject has Type 1 diabetes (as defined by WHO) for at least 24 months • The subject's HbA1c =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Subject is actively enrolled in another clinical trial or took part in a study within 30 days • Experienced recurrent severe hypoglycaemic unawareness (as judged by the investigator) • Total daily insulin dose >= 1.4 IU/kg • Subject is using a medication that significantly impacts glucose metabolism (oral or topical steroids) except if stable for at least the last three months and expected to remain stable for the study duration • Allergy against insulin Lispro • Subject is on psychiatric medication • A history of drug or alcohol dependence • Any other significant concomitant disease such as endocrine, cardiac, neurological, malignant, other pancreatic disease or uncontrolled hypertension as judged by the investigator • Uncontrolled hypertension with resting blood pressure over 140/90 mmHg • Patient is pregnant, or breast feeding during the period of the study • Retinopathy except background retinopathy according to eye fundus examination during the last year • Patient donated blood in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients;Secondary Objective: To investigate safety of the software algorithm To investigate the feasibility to continuously monitor blood glucose To simulate to drive the software algorithm by continuous blood glucose data;Primary end point(s): 15 min in the predefined glucose ranges: post-prandial phase (3 hours after meal): 70-180 mg/dl (3.9-10 mmol/l), all other phases: 70-140 mg/dl (3.9-7.8 mmol/l);Timepoint(s) of evaluation of this end point: Every 15 min over a period of 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Distribution of measured glucose values over the glycaemic range during the entire 24 hour intervention period • Distribution of measured glucose values over the glycaemic range 3 hours after a meal • Number of hypoglycaemic events • Number and reasons for oral glucose intake • Injected insulin dose • Malfunction of the algorithm • Accuracy of the glucose monitoring unit • Difference between the glucose derived from i.v. microdialysis and the corresponding reference glucose;Timepoint(s) of evaluation of this end point: Every 15 min over a period of 24 hours | — |
Countries
Austria
Contacts
Public ContactCoordinating investigator
Medizinische Universität Graz
Outcome results
None listed