Comparison of personal and professional continuous glucose monitoring calibrated using a point-of-care device based on or not based on ISO 15197:2013 criteria

Comparison of personal and professional continuous glucose monitoring calibrated using a point-of-care device based on or not based on ISO 15197:2013 criteria - ISOperpro study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000037523

Enrollment

Registered

2019-07-29

Start date

2019-03-19

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

type 2 diabetes

Interventions

We measure preprandial and bedtime glucose levels on days 2-5 of wearing the CGM devices, in addition, we also measure postprandial glucose levels on days 2 and 5. ISO, next, not ISO group: days 2 and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes who wear personal and professional CGM in parallel for 6 days and whose preprandial and bedtime glucose levels on days 2-5 of wearing the CGM devices, and in addition, postprandial glucose levels on days 2 and 5 can be evaluated.

Exclusion criteria

Exclusion criteria: judged to be unsuitable for participation for medical reasons

Design outcomes

Primary

Measure	Time frame
Comparison between 330 sets of CaI (original index) calibrated by devices based on ISO and 330 sets of that calibrated by devices not based on ISO in both CGM.	—

Secondary

Measure	Time frame
Comparison between 330 sets of absolute relative difference (ARD) calibrated by devices based on ISO and 330 sets of that calibrated by devices not based on ISO, in both CGM. Comparison of 90 sets of CaI or ARD between preprandial and postprandial glucose levels on days 2 or 5 calibrated by devices based on ISO or not based on ISO, in both CGM. Relationship between CaI and ARD in preprandial or postprandial glucose levels on days 2 or 5 calibrated by devices based on ISO or not based on ISO, in both CGM. Prediction ability or cutoff values for ARD > 10% in CaI in preprandial or postprandial glucose levels on days 2 or 5 calibrated by devices based on ISO or not based on ISO, in both CGM.	—

Measure

Time frame

Comparison between 330 sets of absolute relative difference (ARD) calibrated by devices based on ISO and 330 sets of that calibrated by devices not based on ISO, in both CGM. Comparison of 90 sets of CaI or ARD between preprandial and postprandial glucose levels on days 2 or 5 calibrated by devices based on ISO or not based on ISO, in both CGM. Relationship between CaI and ARD in preprandial or postprandial glucose levels on days 2 or 5 calibrated by devices based on ISO or not based on ISO, in both CGM. Prediction ability or cutoff values for ARD > 10% in CaI in preprandial or postprandial glucose levels on days 2 or 5 calibrated by devices based on ISO or not based on ISO, in both CGM.

—

Countries

Japan

Contacts

Public ContactSoichi Takeishi

Inuyama Chuo General Hospital Diabetes

souichi19811225@yahoo.co.jp0568-62-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026