Comparison of the Sensor Accuracy of four Different Real Time Continuous Glucose Monitoring Devices in Adults with Type 1 Diabetes Mellitus. A Quasi-Experimental Study.

Comparison of the Sensor Accuracy of four Different Real Time Continuous Glucose Monitoring Devices in Adults with Type 1 Diabetes Mellitus. A Quasi-Experimental Study. - CompCGM

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035836

Enrollment

Registered

2025-01-08

Start date

2024-09-27

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

E10

Interventions

Group 1: Sensor accuracy of the Dexcom G7 (Dexcom) tested against reference blood glucose (Contour Next One) levels in adult individuals with type 1 diabetes mellitus Group 2: Sensor accuracy of the

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Informed consent obtained. - Adult males or females aged =18 years. - Diagnosed with type 1 diabetes mellitus (>12 months).

Exclusion criteria

Exclusion criteria: Simultaneous enrolment in any other study. - Participants with mental incapacity or language barriers including inadequate understanding or cooperation or who, in the opinion of their general practitioner or the investigator, should notparticipate in the trial. - Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator.

Design outcomes

Primary

Measure	Time frame
- %MARDCGM1-4 or %MedARDCGM1-4: Percentage MARD or MedARD (%) of the four different CGM systems in comparison of trial arms.	—

Secondary

Measure	Time frame
- %TBR-1: time below 70 mg/dL as percentage between trial arms. - %TBR-2: time below 54 mg/dL as percentage between trial arms. - %TIR: time between 70 and 180 mg/dL as percentage between trial arms. - %TAR-1: time spent over 180 mg/dL as percentage between trial arms. - %TAR-2: time spent over 250 mg/dL as percentage between trial arms. - Median absolute relative difference (MedARD) and interquartile range (IQR) between interstitial glucose (CGM) and reference blood glucose for >+2 mg/dL rate of change during exercise sessions in comparisons of trial arms. - Median absolute relative difference (MedARD) and interquartile range (IQR) between interstitial glucose (CGM) and reference blood glucose for +1-2 mg/dL rate of change during exercise sessions in comparisons of trial arms. - Median absolute relative difference (MedARD) and interquartile range (IQR) between interstitial glucose (CGM) and reference blood glucose for -2 mg/dL rate of change during exercise sessions in comparisons of trial arms. - %hypo: Percentage of hypoglycaemic events (%) between trial arms. - %hyper: Percentage of hyperglycaemic events (%) between trial arms.	—

Measure

Time frame

- %TBR-1: time below 70 mg/dL as percentage between trial arms. - %TBR-2: time below 54 mg/dL as percentage between trial arms. - %TIR: time between 70 and 180 mg/dL as percentage between trial arms. - %TAR-1: time spent over 180 mg/dL as percentage between trial arms. - %TAR-2: time spent over 250 mg/dL as percentage between trial arms. - Median absolute relative difference (MedARD) and interquartile range (IQR) between interstitial glucose (CGM) and reference blood glucose for >+2 mg/dL rate of change during exercise sessions in comparisons of trial arms. - Median absolute relative difference (MedARD) and interquartile range (IQR) between interstitial glucose (CGM) and reference blood glucose for +1-2 mg/dL rate of change during exercise sessions in comparisons of trial arms. - Median absolute relative difference (MedARD) and interquartile range (IQR) between interstitial glucose (CGM) and reference blood glucose for -2 mg/dL rate of change during exercise sessions in comparisons of trial arms. - %hypo: Percentage of hypoglycaemic events (%) between trial arms. - %hyper: Percentage of hyperglycaemic events (%) between trial arms.

—

Countries

Germany

Contacts

Public ContactOthmar Moser

Universität Bayreuth

othmar.moser@uni-bayreuth.de+49 (0)921 / 55-3465

Outcome results

None listed

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