Standardized Evaluation of SPIDIMAn Glucose Monitoring System under routine environmental conditions

Not Applicable

• Conditions: Diabetes mellitus type 1; E10; Type 1 diabetes mellitus

• Registration Number: DRKS00009604
• 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: 2015-12-17
• Study Completion: 2016-11-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Informed consent obtained after being advised of the nature of the study;
Male or female aged =18 years;
Type 1 diabetes for at least 6 months according to the WHO definition;
Treatment with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for at least 3 months;
Body Mass Index (BMI) < 35 kg/m²;
Willing and able to wear 4 CGM devices for the duration of the study and undergo all study procedures;
HbA1c = 86 mmol/mol

Exclusion Criteria

Any disease or condition which the investigator feels would interfere with 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
Any mental condition rendering the subject incapable of giving his consent
Subject is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration
Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject’s safety or successful
participation in the study.
Subject is actively enrolled in another clinical trial
Subject donated blood in the last 3 months

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%.

Secondary Outcome Measures

Name	Time	Method
Efficacy:<br>Percentage of sensor values which fall within ± 0,83 mmol/l (±15mg/dl) of the mean reference values at glucose concentrations (<100mg/dl) and within ± 15% at glucose concentrations = 5,55 mmol/l (>100 mg/dl) <br>Safety: <br>Evaluation of skin reactons, iritations of insertion site