Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

NCT02848261 | Completed

• 1 other identifier: 37360
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Time spent in blood glucose range

  Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads.

  Change over 6 months

• Pediatric Quality of Life Inventory

  This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living.

  Change over 6 months

Secondary Outcomes (10)

• A1c

  Change over 6 months

• Problem Areas in Diabetes

  Change over 6 months

• Diabetes Distress Scale

  Change over 6 months

• Patient Health Questionnaire 9

  Change over 6 months

• State-Trait Anxiety Inventory

  Change over 6 months

Study Arms (5)

Developmental Demands

EXPERIMENTAL

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

Behavioral: Developmental Demands

Distress Reduction

EXPERIMENTAL

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

Behavioral: Distress Reduction

Remote Monitoring

EXPERIMENTAL

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

Behavioral: Remote Monitoring

Fear of Hypoglycemia

EXPERIMENTAL

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

Behavioral: Fear of Hypoglycemia

No Intervention

PLACEBO COMPARATOR

Serves as the control group comparator. No intervention provided.

Behavioral: No intervention

Interventions

Developmental Demands BEHAVIORAL

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

Developmental Demands

Distress Reduction BEHAVIORAL

Education and training on reducing distress

Distress Reduction

Remote Monitoring BEHAVIORAL

Education and training on the use of remote monitoring

Remote Monitoring

Fear of Hypoglycemia BEHAVIORAL

Education and training on reducing fear of hypoglycemia

Fear of Hypoglycemia

No intervention BEHAVIORAL

No intervention - serves as the control group

No Intervention

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stanford University: lead
• University of Colorado, Denver: collaborator
• Indiana University: collaborator
• University of South Florida: collaborator

Study Sites (4)

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of South Florida

Tampa, Florida, 33620, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Bruce Buckingham, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Kimberly Driscoll, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Linda DiMeglio, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Henry Rodriguez, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 28, 2016
• Study Start: August 15, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

US (4)