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Completed

NCT Number: NCT02848261

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).

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Stanford, California, United States

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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:

  • Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria
  • Time since diagnosis of at least six months
  • Age between 2 and 6 years at enrollment
  • Parental consent to participate in the study
  • No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in this clinical trial.
  • If current use of CGM, A1c has to be above 7.5%; value obtained within 3 months of enrollment
  • 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:

  • 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
  • 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:

  • 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 Demands

Behavioral

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

Distress Reduction

Behavioral

Education and training on reducing distress

Remote Monitoring

Behavioral

Education and training on the use of remote monitoring

Fear of Hypoglycemia

Behavioral

Education and training on reducing fear of hypoglycemia

No intervention

Behavioral

No intervention - serves as the control group

Primary outcomes

  1. Time spent in blood glucose range

    Time frame: Change over 6 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.

  2. Pediatric Quality of Life Inventory

    Time frame: Change over 6 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.

Secondary outcomes

  1. A1c

    Time frame: Change over 6 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 6 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. Diabetes Distress Scale

    Time frame: Change over 6 months

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

  4. Patient Health Questionnaire 9

    Time frame: Change over 6 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 6 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 6 months

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

  7. Hypoglycemic Fear Survey

    Time frame: Change over 6 months

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

  8. Hypoglycemic Confidence Questionnaire

    Time frame: Change over 6 months

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

  9. Glucose Monitoring System Satisfaction Survey

    Time frame: Change over 6 months

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

  10. General and diabetes-specific technology use

    Time frame: Change over 6 months

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

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

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2016
Registry last updated
Nov 12, 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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