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Supporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System

NCT03354286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-09-25

No results posted yet for this study

Summary

This study will examine the impact of a closed-loop insulin delivery system intervention on health and psychological outcomes in families with young children with Type 1 Diabetes (T1D).

Conditions

  • Type 1 Diabetes Mellitus

Interventions

BEHAVIORAL

Developmental & Technological Demands

Education and training related to use of CGM in this age group

BEHAVIORAL

Distress Reduction

Education and training on reducing distress

BEHAVIORAL

Nutrition, Set Point, & C:I Ratio

Education and training on how to use the HCL system to dose for different kinds of foods to improve glycemic control

BEHAVIORAL

Hypoglycemia management

Education and training on reducing worries of hypoglycemia

BEHAVIORAL

Minimal Intervention

Minimal intervention to simulate standard care - serves as the control group

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • Indiana University

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • University of South Florida

    collaborator OTHER

  • Stanford University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2017-11-07
Primary Completion
2019-03-18
Completion
2019-03-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03354286 on ClinicalTrials.gov