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Completed

NCT Number: NCT03354286

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

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).

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

To be eligible for the study, a child must meet the following criteria since enrollment in the CEP 302 Trial:

  • Diagnosis of type 1 diabetes according to ADA diagnostic criteria
  • Time since diagnosis of at least six months
  • Age between 2.00 and 6.99 years at enrollment
  • Parental consent to participate in the study
  • 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:

  • Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above.
  • Age of 18.0 years or older.
  • Parent comprehends written English.
  • 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):

  • 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).
  • Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
  • Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
  • Child is unable to completely avoid acetaminophen for duration of study

Treatment and study plan

Developmental & Technological Demands

Behavioral

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

Distress Reduction

Behavioral

Education and training on reducing distress

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

Hypoglycemia management

Behavioral

Education and training on reducing worries of hypoglycemia

Minimal Intervention

Behavioral

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

Primary outcomes

  1. Time spent in blood glucose range

    Time frame: Change over 3 months

    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.

Secondary outcomes

  1. Hemoglobin A1c

    Time frame: Change over 3 months

    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.

  2. Problem Areas in Diabetes

    Time frame: Change over 3 months

    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.

  3. Parent Diabetes Distress Scale

    Time frame: Change over 3 months

    This measure is widely used to capture the psychological distress experienced in relation to diabetes.

  4. Patient Health Questionnaire 8

    Time frame: Change over 3 months

    This is a widely used measure that captures depressive symptoms. It is reported by the participants.

  5. State-Trait Anxiety Inventory

    Time frame: Change over 3 months

    This is a widely used measure of anxiety symptoms. It is reported by the participant.

  6. Pittsburgh Sleep Quality Index

    Time frame: Change over 3 months

    This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.

  7. Hypoglycemic Fear Survey - Parents

    Time frame: Change over 3 months

    People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.

  8. Hypoglycemia Confidence Questionnaire

    Time frame: Change over 3 months

    Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations.

  9. Pediatric Quality of Life Inventory

    Time frame: Change over 3 months

    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.

  10. Glucose Monitoring System Satisfaction Survey

    Time frame: Change over 3 months

    This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.

  11. General and diabetes-specific technology use

    Time frame: Change over 3 months

    This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.

  12. Diabetes management behaviors

    Time frame: Change over 3 months

    Amount of time spent in Auto Mode; blood glucose monitoring frequency (by meter download); adherence to pump boluses. It is objectively reported by device downloads.

  13. Health care utilization

    Time frame: Change over 3 months

    Number of visits and calls to the diabetes care team.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Indiana University
  • University of Colorado, Denver
  • University of South Florida
  • Yale University

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2017
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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