Trial Outcomes & Findings for Continuous Glucose Monitoring Following Hospital Discharge (NCT NCT05360056)

NCT ID: NCT05360056

Last Updated: 2025-12-09

Results Overview

Change in %time in range between 70-180 mg/dl from 2 weeks to 12 weeks.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 108 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2025-12-09

Participant Flow

Participant milestones

Measure	Dexcom CGM DexCom G6: Wearable continuous glucose monitor
Overall Study STARTED	108
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	42

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Glucose Monitoring Following Hospital Discharge

Baseline characteristics by cohort

Measure	Dexcom CGM n=108 Participants DexCom G6: Wearable continuous glucose monitor
Age, Categorical <=18 years	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	92 Participants n=4 Participants
Age, Categorical >=65 years	16 Participants n=4 Participants
Age, Continuous	52.3 years STANDARD_DEVIATION 10.9 • n=4 Participants
Sex: Female, Male Female	48 Participants n=4 Participants
Sex: Female, Male Male	60 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	106 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	62 Participants n=4 Participants
Race (NIH/OMB) White	46 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants
Region of Enrollment United States	108 participants n=4 Participants
Baseline HbA1c	11.3 percentage of glycosylated hemoglobin STANDARD_DEVIATION 2.0 • n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 54 participants had data at 2 weeks and 12 weeks

Change in %time in range between 70-180 mg/dl from 2 weeks to 12 weeks.

Outcome measures

Measure	Dexcom CGM n=54 Participants DexCom G6: Wearable continuous glucose monitor
Change in TIR 70-180 mg/dl	8.5 percentage of time spent 70-180 mg/dl Standard Deviation 28

PRIMARY outcome

Timeframe: 12 weeks

Population: 58 participants had CGM wear time at week 12

The number of participants with % wear time >70% will be reported.

Outcome measures

Measure	Dexcom CGM n=58 Participants DexCom G6: Wearable continuous glucose monitor
% Wear Time >70%	54 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 61 participants had an available DTSQ change score at 12 weeks

The DTSQc compares the experience of the current treatment with the experience of the treatment before initiation of the study. Scores range from +3 ("much more satisfied now") to -3 ("much less satisfied now"), with 0 (midpoint) representing no change. Higher scores on the DTSQ total score indicate higher treatment satisfaction, and lower scores indicate lower treatment satisfaction. The total score ranges from -18 (maximum deterioration in satisfaction) to +18 (maximum improvement in satisfaction).A score of 0 indicates no change in satisfaction.

Outcome measures

Measure	Dexcom CGM n=61 Participants DexCom G6: Wearable continuous glucose monitor
DTSQc Score	8 score on a scale Interval 6.0 to 12.0

Adverse Events

Dexcom CGM

Serious events: 0 serious events

Other events: 30 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dexcom CGM n=108 participants at risk DexCom G6: Wearable continuous glucose monitor
Skin and subcutaneous tissue disorders Sensor event	27.8% 30/108 • Number of events 40 • 12 weeks Sensor adverse events include failure, bleeding, pain, infection and puritus

Additional Information

Dr. Kathleen Dungan

The Ohio State University

Phone: 6146853333

Email: kathleen.dungan@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place