Standardized Evaluation of the SPIDIMAN Glucose Monitoring Systems under Routine Environmental Conditions using Prospective Calibration.

Phase 1

• Conditions: E10; Type 1 diabetes mellitus

• Registration Number: DRKS00011488
• Lead Sponsor: Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Diabetologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-13
• Study Completion: 2017-02-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Informed consent obtained after being advised of the nature of the study.
Male or female aged = 18 years.
Diagnosis of Diabetes Mellitus Type 1 for at least 6 months according to WHO criteria.
Treatment with multiple daily injections (MDI) or continous subcutaneous insulin infusion for at least 3 months.
Body Mass Index (BMI) < 35kg/m²
Willing and able to wear 4 SPIDIMAN Glucosemonitoring Systems for the duration of the and undergo all study procedures
HbA1c = 86 mmol/mol

Exclusion Criteria

Any disease or condition which the investigator feels would interfere with the participation in the trial or the safety of the subject.
Female of childbearing potential who is pregnant, breast feeding or intend to become pregnant or is not using adequate contraceptive methods.
Inability of subjects to understand subject information.
Inability of subject to sign the subject informed consent form
Intake of any medication that significantly impacts glucose metabolism (oral steroids).
Subject donated blood in the last 3 months
Intake of paracetamol while participatiin the the clinical study.
Severe medical or psychological condition or chronic condition that in the opinion of the investigator would compromise the subject's safety or successful participation in the clinical study.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) =15%.<br>Measurements from 4 SPIDIMAN sensors compared to plasma glucose values as measured by Super GL.<br>

Secondary Outcome Measures

Name	Time	Method
Percentage of sensor values which fall within ± 0.83 mmol/l (±15mg/dl) of the mean reference values at glucose concentrations < 5.55 mmol/l (<100mg/dl) and within ± 15% at glucose concentrations = 5.55 mmol/l (>100 mg/dl).<br>Glucagon concentrations during fasting, exercise and in the post-prandial state.<br>Correlation of glucagon concentrations with sensor glucose values from the 4 SPIDIMAN sensors.