Trial Outcomes & Findings for CGM Use in Children With Type 2 Diabetes (NCT NCT04721158)

NCT ID: NCT04721158

Last Updated: 2023-09-15

Results Overview

The percentage of total time that the patient uses the continuous glucose monitor (CGM) where the blood glucose falls between 70 and 180 mg/dL

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 41 participants
• Primary outcome timeframe: 5 days, 10 days
• Results posted on: 2023-09-15

Participant Flow

Participant milestones

Measure	CGM Sample Given Youth with T2D \> 3 months, on insulin, with no prior CGM use were enrolled
Overall Study STARTED	41
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	CGM Sample Given Youth with T2D \> 3 months, on insulin, with no prior CGM use were enrolled
Overall Study Lost to Follow-up	4
Overall Study Device did not connect	1

Baseline Characteristics

CGM Use in Children With Type 2 Diabetes

Baseline characteristics by cohort

Measure	CGM Arm n=41 Participants Children with type 2 diabetes will wear a continuous glucose monitor for 10 days. Continuous glucose monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Age, Continuous	16.2 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	34 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants
HbA1c	10.3 Percentage of glycosylated hemoglobin n=5 Participants

PRIMARY outcome

Timeframe: 5 days, 10 days

Population: Participants with CGM use at both 5-days and 10-days

The percentage of total time that the patient uses the continuous glucose monitor (CGM) where the blood glucose falls between 70 and 180 mg/dL

Outcome measures

Measure	CGM Sample Given n=18 Participants Youth with T2D \> 3 months, on insulin, with no prior CGM use were enrolled
Percentage of Time in Range Glucose Control 5 days	49.2 percentage of time in target range Standard Deviation 38
Percentage of Time in Range Glucose Control 10 days	50.7 percentage of time in target range Standard Deviation 39

PRIMARY outcome

Timeframe: Baseline, 3 - 6 months

Population: Participants with A1c available at baseline and 3-6 months

HbA1c at baseline and 3-6 month follow-up.

Outcome measures

Measure	CGM Sample Given n=30 Participants Youth with T2D \> 3 months, on insulin, with no prior CGM use were enrolled
Hemoglobin A1c Baseline	10.2 percentage of glycosylated hemoglobin A1 Standard Deviation 2.8
Hemoglobin A1c 3-6 months	10.3 percentage of glycosylated hemoglobin A1 Standard Deviation 3.2

PRIMARY outcome

Timeframe: 10 days from CGM placement

Population: Participants with 10 day follow up surveys

Response to "Did you take your insulin more often than before?"

Outcome measures

Measure	CGM Sample Given n=24 Participants Youth with T2D \> 3 months, on insulin, with no prior CGM use were enrolled
More Frequent Insulin Administration Yes	14 Participants
More Frequent Insulin Administration No	8 Participants
More Frequent Insulin Administration Sometimes	2 Participants

PRIMARY outcome

Timeframe: 10 days

Population: Participants who responded to the survey conducted at 10 day follow up.

Response to "Do you look at or check your blood sugar more often than before?"

Outcome measures

Measure	CGM Sample Given n=24 Participants Youth with T2D \> 3 months, on insulin, with no prior CGM use were enrolled
More Frequent Glycemic Control Monitoring Yes	23 Participants
More Frequent Glycemic Control Monitoring No	0 Participants
More Frequent Glycemic Control Monitoring Sometimes	1 Participants

Adverse Events

CGM Arm

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	CGM Arm n=41 participants at risk Children with type 2 diabetes will wear a continuous glucose monitor for 10 days. Continuous glucose monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Endocrine disorders DKA admission	4.9% 2/41 • Number of events 2 • 6 months

Other adverse events

Adverse event data not reported

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