Combining Glucagon and Insulin Delivery with Glucose Sensing in Fat Tissue of Diabetes Patients

Combining Glucagon and Insulin Infusion with Glucose Sensing in Subcutaneous Adipose Tissue of Type 1 Diabetes Patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002342-30-AT

Enrollment

Registered

2015-06-15

Start date

2015-07-14

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus type 1 MedDRA version: 18.0 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 100000004861

Interventions

Trade Name: GlucaGen Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: GLUCAGON CAS Number: 16941-32-5 Concentration unit: mg/ml milligram(s)/millilitre Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Type 1 diabetes treated with CSII - 18 to 64 years of age, both inclusive - HbA1C =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to ascertain in humans whether 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)	—

Measure

Time frame

Main Objective: The main objective of this study is to ascertain in humans whether 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)

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Secondary

Measure	Time frame
Secondary end point(s): - Median absolute relative differences (median ARD) calculated by determining the median of the absolute value of the percentage difference between each paired sensor and blood glucose concentration - Residual mean determined by applying the method of residuals - 2 SD value determined by applying the method of residuals - Percentage values of the sensor readings in the zones A, B, C, D, and E of the Clark error grid (18) ;Timepoint(s) of evaluation of this end point: over the duration of the study day (24 hours)	—

Measure

Time frame

Secondary end point(s): - Median absolute relative differences (median ARD) calculated by determining the median of the absolute value of the percentage difference between each paired sensor and blood glucose concentration - Residual mean determined by applying the method of residuals - 2 SD value determined by applying the method of residuals - Percentage values of the sensor readings in the zones A, B, C, D, and E of the Clark error grid (18) ;Timepoint(s) of evaluation of this end point: over the duration of the study day (24 hours)

—

Countries

Austria

Contacts

Public ContactZentrum f. Med. Grundlagenforschung

Medizinische Universität Graz; Universitätsklinik für InnereMedizin; Abteilung für Endokrinologie und Stoffwechsel

werner.regittnig@medunigraz.at+4331638572831

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026