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CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D)

NCT03263494 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2020-03-03

No results posted yet for this study

Summary

Adolescents and young adults with T1D and poor glycemic control (age 14-\< 25 years, T1D duration \>12 months, HbA1c 7.5-\<11.0%, using an insulin pump or MDI)) will be randomly assigned to either CGM or BGM. Sample size will be 150. The primary outcome assessment will be HbA1c after 6 months. Secondary outcomes will include HbA1c, CGM metrics (control group will wear blinded CGM at 13 and 24 weeks), and quality of life measures. The randomized trial will be followed by a 6-month extension study during which the RCT control group will initiate CGM and the RCT CGM group will continue CGM.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Continuous Glucose Monitor (CGM)

Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.

Sponsors & Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

  • Jaeb Center for Health Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-25
Primary Completion
2019-05-08
Completion
2019-11-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03263494 on ClinicalTrials.gov