Trial Outcomes & Findings for Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform (NCT NCT04369833)

Last Updated: 2022-05-09

Results Overview

the prevalence of insulin resistance in participants was measured. Insulin resistance was calculated by HOMA-IR(homeostatic model assessment of insulin resistance), QUICKI (quantitative insulin sensitivity check index) and Matsuda index

Recruitment status

COMPLETED

Target enrollment

130 participants

Primary outcome timeframe

1 week

Results posted on

2022-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Continuous Glucose Monitoring Group all participants wearing a continuous glucose monitoring device continuous glucose monitoring system: wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)
Overall Study STARTED	130
Overall Study COMPLETED	129
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Glucose Monitoring Group n=129 Participants all participants wearing a continuous glucose monitoring device continuous glucose monitoring system: wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)
Age, Continuous	56.6 years STANDARD_DEVIATION 12.15 • n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	129 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment South Korea	129 participants n=5 Participants
Mean CGM glucose	122.6 mg/dL STANDARD_DEVIATION 15.5 • n=5 Participants
the coefficient of variation of CGM glucose	19.6 percentage of coefficient of variation STANDARD_DEVIATION 6.4 • n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring Group n=129 Participants all participants wearing a continuous glucose monitoring device continuous glucose monitoring system: wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)
Number of Participants With Insulin Resistance	69 Participants

Adverse Events

Continuous Glucose Monitoring Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Continuous Glucose Monitoring Group n=129 participants at risk all participants wearing a continuous glucose monitoring device continuous glucose monitoring system: wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)
Skin and subcutaneous tissue disorders bleeding on CGM insertion site	0.78% 1/129 • Number of events 1 • 1 week

Additional Information

Dr. Sang Soo Kim

Pusan national university hospital

Phone: +82-51-240-7837

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place