Trial Outcomes & Findings for CGM Use in Poorly Controlled Youth With Type 1 Diabetes (NCT NCT04721145)

NCT ID: NCT04721145

Last Updated: 2023-08-04

Results Overview

Evaluate whether there is any change in uptake of personal CGM after 10-day trial.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: Baseline and 3 months
• Results posted on: 2023-08-04

Participant Flow

Participant milestones

Measure	Dexcom G6 Continuous Glucose Monitor Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days. Dexcom G6 Continuous Glucose Monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CGM Use in Poorly Controlled Youth With Type 1 Diabetes

Baseline characteristics by cohort

Measure	Dexcom G6 Continuous Glucose Monitor n=26 Participants Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days. Dexcom G6 Continuous Glucose Monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Age, Continuous	14.1 years STANDARD_DEVIATION 2.9 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Non-Hispanic White	11 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Non-Hispanic Black	11 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Multi-racial (American Indian / White)	1 Participants n=5 Participants
Region of Enrollment United States	26 Participants n=5 Participants
Insurance Public Insurance	17 Participants n=5 Participants
Insurance Private Insurance	9 Participants n=5 Participants
HbA1c	10.7 Percentage STANDARD_DEVIATION 2.4 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Evaluate whether there is any change in uptake of personal CGM after 10-day trial.

Outcome measures

Measure	Dexcom G6 Continuous Glucose Monitor n=26 Participants Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days. Dexcom G6 Continuous Glucose Monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Change in Personal CGM Use Wants a personal CGM	22 Participants
Change in Personal CGM Use Does not want a personal CGM	4 Participants

SECONDARY outcome

Timeframe: 1-5 days and 6-10 days

Population: Only 15/26 participants had data from both periods

Changes in time in range glucose control from 1-5 days to 6-10 days from the Dexcom CGM

Outcome measures

Measure	Dexcom G6 Continuous Glucose Monitor n=15 Participants Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days. Dexcom G6 Continuous Glucose Monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Change in the Percent Time in Range Glucose Control 1-5 days	41.9 Percentage of time in range Standard Deviation 21.2
Change in the Percent Time in Range Glucose Control 6-10 days	32.8 Percentage of time in range Standard Deviation 15.2

SECONDARY outcome

Timeframe: Baseline, 3-6 months

Population: 20/26 participants had a follow up A1c lab available.

Changes in HbA1c from baseline to next available A1c at 3-6 month follow up visit

Outcome measures

Measure	Dexcom G6 Continuous Glucose Monitor n=20 Participants Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days. Dexcom G6 Continuous Glucose Monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Change in Hemoglobin A1c Baseline	10.9 Percentage Standard Deviation 2.6
Change in Hemoglobin A1c 3-6 month follow up	10.8 Percentage Standard Deviation 2.6

SECONDARY outcome

Timeframe: 3-6 months

Population: 21/26 participants wanted a personal CGM AND completed 3-6 month follow-up. (Of the total participants 4 participants did not want CGM. 1 participant had no 3-6 month follow up. Thus, this analysis includes the remaining 21 participants.)

Percentage of participants using CGM at time of follow up, of those who reported wanting a personal CGM

Outcome measures

Measure	Dexcom G6 Continuous Glucose Monitor n=21 Participants Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days. Dexcom G6 Continuous Glucose Monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Using Personal CGM	9 Participants

Adverse Events

Dexcom G6 Continuous Glucose Monitor

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dexcom G6 Continuous Glucose Monitor n=26 participants at risk Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days. Dexcom G6 Continuous Glucose Monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Endocrine disorders DKA admission	15.4% 4/26 • Number of events 4 • 6 months
Renal and urinary disorders ER Visit, renal stone	3.8% 1/26 • Number of events 1 • 6 months
Gastrointestinal disorders Abdominal Pain	3.8% 1/26 • Number of events 1 • 6 months

Other adverse events

Measure	Dexcom G6 Continuous Glucose Monitor n=26 participants at risk Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days. Dexcom G6 Continuous Glucose Monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Ear and labyrinth disorders Otalgia of both ears	3.8% 1/26 • Number of events 1 • 6 months

Additional Information

Dr. Risa Wolf

Johns Hopkins Medicine

Phone: 410-955-6463

Email: rwolf@jhu.edu

Results disclosure agreements

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