Completed

Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Developmental Demands

+ Distress Reduction

+ Remote Monitoring

Behavioral
Who is being recruted

Autoimmune Diseases+5

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

From 2 to 6 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: August 2016
See protocol details

Summary

Principal SponsorStanford University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 15, 2016

Actual date on which the first participant was enrolled.

The primary objective of this project is to examine the impact of a continuous glucose monitoring (CGM) intervention on health and psychological outcomes in young children with type 1 diabetes (T1D).

Official TitleRemote Monitoring of Diabetes in Young Children With Type 1 Diabetes
Principal SponsorStanford University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

92 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 6 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Endocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

To be eligible for the study, a child must meet the following criteria: 1. Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria 2. Time since diagnosis of at least six months 3. Age between 2 and 6 years at enrollment 4. Parental consent to participate in the study 5. No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in this clinical trial. 6. If current use of CGM, A1c has to be above 7.5%; value obtained within 3 months of enrollment 7. Own and use an iPhone, or be willing/able to carry a study-supplied wi-fi enabled iPod To be eligible for the study, a parent must meet the following criteria: 1. Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above 2. Age of 18.0 years or older 3. Parent comprehends written English 4. Parent understands the study protocol and signs the informed consent document 5. Parent has access to a personal computer to upload diabetes devices and send to research team The presence of any of the following is an exclusion for the study: 1. Child has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol (e.g., pregnancy, kidney disease, adrenal insufficiency, skin condition that may hinder sensor application). 2. Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol 3. Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study 4. Child is unable to completely avoid acetaminophen for duration of study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

20% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving.

Group II

Experimental
Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.

Group III

Experimental
Optimize the use of remote monitoring by focusing on situational demands and problem solving.

Group IV

Experimental
Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.

Group 5

Placebo
Serves as the control group comparator. No intervention provided.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Stanford University

Stanford, United StatesOpen Stanford University in Google Maps
Suspended

University of Colorado

Aurora, United States
Suspended

University of South Florida

Tampa, United States
Suspended

Indiana University

Indianapolis, United States
Completed4 Study Centers