Clinical trial NCT02848261: Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
Official title: Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Indiana University
name: University of South Florida
First posted: 2016-07-28
Enrollment: 92
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Time spent in blood glucose range
timeFrame: Change over 6 months
measure: Pediatric Quality of Life Inventory
timeFrame: Change over 6 months
Secondary outcomes:
measure: A1c
timeFrame: Change over 6 months
measure: Problem Areas in Diabetes
timeFrame: Change over 6 months
measure: Diabetes Distress Scale
timeFrame: Change over 6 months
measure: Patient Health Questionnaire 9
timeFrame: Change over 6 months
measure: State-Trait Anxiety Inventory
timeFrame: Change over 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Change over 6 months
measure: Hypoglycemic Fear Survey
timeFrame: Change over 6 months
measure: Hypoglycemic Confidence Questionnaire
timeFrame: Change over 6 months
measure: Glucose Monitoring System Satisfaction Survey
timeFrame: Change over 6 months
measure: General and diabetes-specific technology use
timeFrame: Change over 6 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Stanford University
name: Bruce Buckingham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Kimberly Driscoll, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Linda DiMeglio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Henry Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References: