CGM Use in Children With Type 2 Diabetes

NCT04721158 — Not applicable, Completed, 41 participants, Johns Hopkins University

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IMPlementation of Continuous Glucose Monitoring in Children With Type 2 Diabetes

Registry	NCT04721158, acronym IMPaCT2
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, supportive care
Enrollment	41 (Actual)
Sponsor	Johns Hopkins University (Other)
Conditions	Type 2 Diabetes, Hyperglycemia Due to Type 2 Diabetes Mellitus
Interventions	Continuous glucose monitor (Device)
Dates	start 2021-01-17, primary completion 2022-07-28, completion 2022-07-28, first posted 2021-01-22, last updated 2023-09-15
Locations	1 site in United States

-Summary

The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for a 10 day wear period in pediatric Type 2 diabetes patients improves short term time in range glucose control and 3-6 month glycemic control.

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+Detailed description

The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for 10 days has an impact on short and long term glycemic control and behavior in youth onset Type 2 diabetes.

+Arms and interventions

Arm	Type	Interventions	Description
CGM Arm	Other	Device: Continuous glucose monitor	Children with type 2 diabetes will wear a continuous glucose monitor for 10 days.

Continuous glucose monitor (Device), also known as Dexcom G6 CGM: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.

+Outcome measures

Primary outcomes

Percentage of Time in Range Glucose Control [5 days, 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
Hemoglobin A1c [Baseline, 3 - 6 months]: HbA1c at baseline and 3-6 month follow-up.
More Frequent Insulin Administration [10 days from CGM placement]: Response to "Did you take your insulin more often than before?"
More Frequent Glycemic Control Monitoring [10 days]: Response to "Do you look at or check your blood sugar more often than before?"

+Eligibility

Sex: All, ages: 5 Years to 21 Years

Inclusion Criteria:

* Type 2 diabetes, diabetes duration >3 months

Exclusion Criteria:

* Prior use of CGM

+Posted results

Participant flow

Milestone	CGM Sample Given
Started	41
Completed	36
Not completed	5

Outcome results

Percentage of Time in Range Glucose Control (Primary), Mean, percentage of time in target range: CGM Sample Given 49.2 +/- 38
Hemoglobin A1c (Primary), Mean, percentage of glycosylated hemoglobin A1: CGM Sample Given 10.2 +/- 2.8
More Frequent Insulin Administration (Primary), Count of participants, Participants: CGM Arm 14
More Frequent Glycemic Control Monitoring (Primary), Count of participants, Participants: CGM Arm 23

Adverse events

Time frame: 6 months

Arm	Deaths	Serious adverse events	Other adverse events
CGM Arm	0/41 (0.0%)	2/41 (4.9%)	0/41 (0.0%)

Serious adverse events by term

Term	Organ system	CGM Arm
DKA admission	Endocrine disorders	2/41

Limitations and caveats: The limitations of this study include the small study size with a limited number of participants completing both 10-day trial period and 3/6-month follow up visits. There were a large number of patients who had device connectivity and adhesive issues. Many participants were lost to follow up.

+Locations (1)

Facility	City	Country	Status
Johns Hopkins Pediatric Diabetes Center	Baltimore, Maryland	United States

+Publications

Results publication: Phu A, Lin T, Manfredo JA, Brown EA, Wolf RM. Similar Perceptions on Continuous Glucose Monitor Use amongst Youth with Type 1 and Type 2 Diabetes. Pediatr Diabetes. 2023 Jun 19;2023:1979635. doi: 10.1155/2023/1979635. eCollection 2023. PMID 40303266

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2023-07-12)

+Investigators

Risa M Wolf, MD, Principal investigator, Johns Hopkins School of Medicine

My Notes

Public

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