Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:2 - 6
Updated:5/11/2018
Start Date:August 15, 2016
End Date:August 2019
Contact:Regan Barley
Email:rcbarley@stanford.edu
Phone:650-736-1517

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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).


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
We found this trial at
3
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Aurora, Colorado 80045
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Bruce Buckingham, MD
Phone: 650-736-1517
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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