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Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02848261
Enrollment
92
Registered
2016-07-28
Start date
2016-08-15
Completion date
2019-04-30
Last updated
2019-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

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).

Interventions

BEHAVIORALDevelopmental Demands

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

Education and training on reducing distress

BEHAVIORALRemote Monitoring

Education and training on the use of remote monitoring

Education and training on reducing fear of hypoglycemia

BEHAVIORALNo intervention

No intervention - serves as the control group

Sponsors

University of Colorado, Denver
CollaboratorOTHER
Indiana University
CollaboratorOTHER
University of South Florida
CollaboratorOTHER
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Time spent in blood glucose rangeChange over 6 monthsIncreasingly 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.
Pediatric Quality of Life InventoryChange over 6 monthsThis 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

MeasureTime frameDescription
Diabetes Distress ScaleChange over 6 monthsThis measure is widely used to capture the psychological distress experienced in relation to diabetes.
Patient Health Questionnaire 9Change over 6 monthsThis is a widely used measure that captures depressive symptoms. It is reported by the participants.
State-Trait Anxiety InventoryChange over 6 monthsThis is a widely used measure of anxiety symptoms. It is reported by the participant.
Pittsburgh Sleep Quality IndexChange over 6 monthsThis questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.
A1cChange over 6 monthsThe 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.
Hypoglycemic Confidence QuestionnaireChange over 6 monthsHypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations.
Glucose Monitoring System Satisfaction SurveyChange over 6 monthsThis a measure used to capture overall satisfaction with glucose monitoring devices used by participants.
General and diabetes-specific technology useChange over 6 monthsThis measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.
Hypoglycemic Fear SurveyChange over 6 monthsPeople with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.
Problem Areas in DiabetesChange over 6 monthsThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026