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

NCT03354286 | Completed

• 1 other identifier: 43167
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

670G; Hybrid closed-loop system; pediatric

Outcome Measures

Primary Outcomes (1)

• 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 3 months

Secondary Outcomes (13)

• Hemoglobin A1c

  Change over 3 months

• Problem Areas in Diabetes

  Change over 3 months

• Parent Diabetes Distress Scale

  Change over 3 months

• Patient Health Questionnaire 8

  Change over 3 months

• State-Trait Anxiety Inventory

  Change over 3 months

Study Arms (5)

Developmental & Technological 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. Identify and troubleshoot barriers to keeping young children in Auto Mode.

Behavioral: Developmental & Technological Demands

Distress Reduction

EXPERIMENTAL

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

Behavioral: Distress Reduction

Nutrition, Set Point, & C:I Ratio

EXPERIMENTAL

Provide education on a variety of properties of food and how they affect blood glucose levels. Optimize the use of carbohydrate to Insulin ratios, insulin duration of action, and use of temporary target glucose set point in the 670G pump and the Quick bolus feature to gain better glycemic control.

Behavioral: Nutrition, Set Point, & C:I Ratio

Hypoglycemia management

EXPERIMENTAL

Focus on hypoglycemia management to avoid hyperglycemia, review fear of hypoglycemia

Behavioral: Hypoglycemia management

Minimal Intervention

PLACEBO COMPARATOR

A short communication detailing the percentage of time spent in range and in Auto Mode and if the goals have been met.

Behavioral: Minimal Intervention

Interventions

Developmental & Technological Demands BEHAVIORAL

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

Developmental & Technological Demands

Distress Reduction BEHAVIORAL

Education and training on reducing distress

Distress Reduction

Nutrition, Set Point, & C:I Ratio BEHAVIORAL

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

Nutrition, Set Point, & C:I Ratio

Hypoglycemia management BEHAVIORAL

Education and training on reducing worries of hypoglycemia

Hypoglycemia management

Minimal Intervention BEHAVIORAL

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

Minimal 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 since enrollment in the CEP 302 Trial: 1. Diagnosis of type 1 diabetes according to ADA diagnostic criteria 2. Time since diagnosis of at least six months 3. Age between 2.00 and 6.99 years at enrollment 4. Parental consent to participate in the study 5. Completion of the CEP 302 Trial and in the continuation phase of the Medtronic CEP 302 Trial using the Medtronic MiniMed 670G pump with Enlite3 sensor. 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. The presence of any of the following is an exclusion for the study (since enrollment in the CEP 302 Trial): 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
• Yale University: collaborator
• University of South Florida: collaborator

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Growth and Development; Nutritional Status

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)

Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Health Status; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Pediatrics, Endocrinology and Diabetes Division

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: November 7, 2017
• Primary Completion: March 18, 2019
• Study Completion: March 18, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)