CGM Use in Children With Type 2 Diabetes

NCT04721158 | Completed Results FDA Device

• 1 other identifier: IRB00255470-2
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Hyperglycemia Due to Type 2 Diabetes Mellitus

Keywords

continuous glucose monitoring (CGM); Hemoglobin A1c

Outcome Measures

Primary Outcomes (4)

• Percentage of Time in Range Glucose Control

  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

  5 days, 10 days

• Hemoglobin A1c

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

  Baseline, 3 - 6 months

• More Frequent Insulin Administration

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

  10 days from CGM placement

• More Frequent Glycemic Control Monitoring

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

  10 days

Study Arms (1)

CGM Arm

OTHER

Children with type 2 diabetes will wear a continuous glucose monitor for 10 days.

Device: Continuous glucose monitor

Interventions

Continuous glucose monitor DEVICE

Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.

Also known as: Dexcom G6 CGM

CGM Arm

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Type 2 diabetes, diabetes duration \>3 months

You may not qualify if:

• Prior use of CGM

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Pediatric Diabetes Center

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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.

Results Point of Contact

• Title: Dr. Risa Wolf
• Organization: Johns Hopkins Medicine

rwolf@jhu.edu

410-955-6463

Study Officials

• Risa M Wolf, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 22, 2021
• Study Start: January 17, 2021
• Primary Completion: July 28, 2022
• Study Completion: July 28, 2022
• Last Updated: September 15, 2023
• Results First Posted: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)