CGM Use in Poorly Controlled Youth With Type 1 Diabetes

NCT04721145 | Completed Results FDA Device

• 1 other identifier: IRB00255470
• Study Type: interventional
• Target: 26
• 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 high risk, poorly controlled pediatric Type 1 diabetes patients increases uptake of personal CGM use, and improves short-term time in range glucose control.

Conditions

Type 1 Diabetes; Hypoglycemia; High Blood Sugar

Keywords

Continuous Glucose Monitoring; Time in range; Hemoglobin A1c

Outcome Measures

Primary Outcomes (1)

• Change in Personal CGM Use

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

  Baseline and 3 months

Secondary Outcomes (3)

• Change in the Percent Time in Range Glucose Control

  1-5 days and 6-10 days

• Change in Hemoglobin A1c

  Baseline, 3-6 months

• Using Personal CGM

  3-6 months

Study Arms (1)

Dexcom G6 Continuous Glucose Monitor

EXPERIMENTAL

Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days.

Device: Dexcom G6 Continuous Glucose Monitor

Interventions

Dexcom G6 Continuous Glucose Monitor DEVICE

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

Dexcom G6 Continuous Glucose Monitor

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Type 1 diabetes for \>3 months

You may not qualify if:

• CGM use in the last 6 months

Sponsors & Collaborators

• Johns Hopkins University: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Johns Hopkins Pediatric Diabetes Center

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• 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

• Lin T, Manfredo JA, Illesca N, Abiola K, Hwang N, Salsberg S, Akhtar Y, Mathioudakis N, Brown EA, Wolf RM. Improving Continuous Glucose Monitoring Uptake in Underserved Youth with Type 1 Diabetes: The IMPACT Study. Diabetes Technol Ther. 2023 Jan;25(1):13-19. doi: 10.1089/dia.2022.0347. Epub 2022 Nov 7.

  PMID: 36223197 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The patient cohort was small, and may not be generalizable to all patients with T1D. Further, the mean HbA1c of individuals in the study was well above ADA target, and the impact of trial CGM on patients with HbA1c closer to goal ADA range may be different. Additionally, follow-up CGM data was not available for most patients, thus limiting data for analysis.

Results Point of Contact

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

rwolf@jhu.edu

410-955-6463

Study Officials

• Risa Wolf, MD

  Johns Hopkins University

  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 25, 2021
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: August 4, 2023
• Results First Posted: August 4, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)