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Trial of Early Initiation of CGM-Guided Insulin Therapy in Stage 2 T1D

NCT04335513 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-05-09

No results posted yet for this study

Summary

This protocol is an intervention study to determine the best education and monitoring strategy for children ages 2-20 years with pre-symptomatic type 1 diabetes (T1D) because there currently exists no clinical guidelines for management of these children in early-stage T1D. This study hypothesizes that the trajectory of T1D can be changed, substantially reducing HbA1c and risk of DKA at diagnosis, through (1) careful monitoring of children progressing from stage 2 to stage 3 T1D using continuous glucose monitor (CGM) technology, (2) staged education targeted to assist families in recognizing evolving dysglycemia, and (3) addressing glycemic abnormalities with early initiation of insulin.

Conditions

Interventions

OTHER

Early CGM-guided education and initiation of insulin therapy.

Careful monitoring of children progressing from stage 2 to stage 3 T1D using continuous glucose monitor (CGM) technology, staged education targeted to assist families in recognizing evolving dysglycemia, and addressing glycemic abnormalities with early initiation of insulin can substantially reduce the HbA1c and risk of DKA at diagnosis, thereby changing the trajectory of the disease course.

OTHER

Usual care: glucometer surveillance and basic education.

* Usual education and advice on glycemic surveillance based on protocols of TEDDY/DAISY/ASK. * Blinded CGM for 10 days every 3 months to collect data on glycemic profile with basic feedback regarding changes.

Sponsors & Collaborators

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

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Brigitte I Frohnert, MD, PhD · Barbara Davis Center for Diabetes, University of Colorado

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04335513 on ClinicalTrials.gov