Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

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).

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Distress Reduction; Behavioral: Developmental Demands; Behavioral: Remote Monitoring; Behavioral: Fear of Hypoglycemia; Behavioral: No intervention

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Florida
    • Tampa, Florida, United States, 33620
      • University of South Florida
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distress Reduction; Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.	Behavioral: Distress Reduction; Education and training on reducing distress
Experimental: Developmental Demands; 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; Education and training related to use of CGM in this age group
Experimental: Remote Monitoring; Optimize the use of remote monitoring by focusing on situational demands and problem solving.	Behavioral: Remote Monitoring; Education and training on the use of remote monitoring
Experimental: Fear of Hypoglycemia; Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.	Behavioral: Fear of Hypoglycemia; Education and training on reducing fear of hypoglycemia
Placebo Comparator: No Intervention; Serves as the control group comparator. No intervention provided.	Behavioral: No intervention; No intervention - serves as the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
A1c	The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes. Collected through a blood sample.	Change over 6 months
Problem Areas in Diabetes	This measure captures areas that are reported as problems for people with diabetes. Participants in the study report on daily problems with diabetes via this measure.	Change over 6 months
Diabetes Distress Scale	This measure is widely used to capture the psychological distress experienced in relation to diabetes.	Change over 6 months
Patient Health Questionnaire 9	This is a widely used measure that captures depressive symptoms. It is reported by the participants.	Change over 6 months
State-Trait Anxiety Inventory	This is a widely used measure of anxiety symptoms. It is reported by the participant.	Change over 6 months
Pittsburgh Sleep Quality Index	This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.	Change over 6 months
Hypoglycemic Fear Survey	People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.	Change over 6 months
Hypoglycemic Confidence Questionnaire	Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations.	Change over 6 months
Glucose Monitoring System Satisfaction Survey	This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.	Change over 6 months
General and diabetes-specific technology use	This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.	Change over 6 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: University of Colorado, Denver; University of South Florida; Indiana University
• Investigators: Principal Investigator: Linda DiMeglio, MD, Indiana University; Principal Investigator: Kimberly Driscoll, PhD, University of Colorado, Denver; Principal Investigator: Henry Rodriguez, MD, University of South Florida

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2016
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 7, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 37360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES