Combining Glucagon and Insulin Delivery with Glucose Sensing in Fat Tissue of Diabetes Patients
- Conditions
- Diabetes Mellitus type 1MedDRA version: 18.0Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependentSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2015-002342-30-AT
- Lead Sponsor
- Medizinische Universität Graz; Universitätsklinik für InnereMedizin; Abteilung für Endokrinologie und Stoffwechsel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 8
- Type 1 diabetes treated with CSII
- 18 to 64 years of age, both inclusive
- HbA1C < 10%
- C-peptide < 30 pmol/L
- BMI between 20 and 30 kg/m2
- Signed informed consent before any study-related
activities
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 8
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Severe acute diseases
- Clinically overt diabetic complications
- Mental incapacity, unwillingness or language barriers
precluding adequate understanding or co-operation
- Taking of any vasoactive substances or anticoagulation
medication
- Diseases of the skin which could interfere with
application of catheters as judged by the investigator
- Uncontrolled hypertension
- Use of a medication that significantly impacts glucose
metabolism (e.g. oral or topical steroids) except in the
case of a stable state with a minimum duration of at
least three months preceding the study as well as under
the condition that the state remain stable for the
duration of the study
- No superficial veins for catheter insertion as judged by
the investigator
- Pregnancy, breastfeeding, intention of becoming
pregnant or not using adequate contraception.
- Any disease or condition which the investigator or
treating physician feels would interfere with the trial or
the safety of the subject
- Blood donation within three months preceding the study
- Concurrent participation in another study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of this study is to ascertain in humans whether<br>glucose sensing can be performed at the subcutaneous site of glucagon and insulin infusion.;Secondary Objective: Not applicable;Primary end point(s): Mean absolute relative differences (MARD) calculated by determining the mean of the absolute value of the percentage difference between each paired sensor and blood glucose concentration ;Timepoint(s) of evaluation of this end point: over the duration of the study day (24 hours)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Median absolute relative differences (median ARD) <br> calculated by determining the median of the absolute <br> value of the percentage difference between each <br> paired sensor and blood glucose concentration<br>- Residual mean determined by applying the method of <br> residuals <br>- 2 SD value determined by applying the method of <br> residuals <br>- Percentage values of the sensor readings in the zones A, <br> B, C, D, and E of the Clark error grid (18) <br>;Timepoint(s) of evaluation of this end point: over the duration of the study day (24 hours)