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Strategies to Enhance New CGM Use in Early Childhood (SENCE)

NCT02912728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2020-10-05

No results posted yet for this study

Summary

The primary objective of this study is to compare the efficacy and safety of CGM alone and CGM combined with a family behavioral intervention with a control group using home blood glucose monitoring (BGM) alone.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

BEHAVIORAL

CGM + Family Behavioral Intervention

use of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence

DEVICE

Standard CGM

use of CGM alone to assess CGM adherence

Sponsors & Collaborators

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

    collaborator OTHER

  • Indiana University School of Medicine

    collaborator OTHER

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Linda DiMeglio, MD, MPH · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
2 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2019-06-30
Completion
2019-06-30
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 NCT02912728 on ClinicalTrials.gov