Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

Stanford University

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Behavioral: Developmental Demands; Behavioral: Remote Monitoring; Behavioral: Distress Reduction; Behavioral: Fear of Hypoglycemia; Behavioral: No intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02848261

37360

Details and patient eligibility

About

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).

Enrollment: 92 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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92 participants in 5 patient groups, including a placebo group

Developmental Demands

Experimental group

Description:

Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving.

Treatment:

Behavioral: Developmental Demands

Distress Reduction

Experimental group

Description:

Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.

Treatment:

Behavioral: Distress Reduction

Remote Monitoring

Experimental group

Description:

Optimize the use of remote monitoring by focusing on situational demands and problem solving.

Treatment:

Behavioral: Remote Monitoring

Fear of Hypoglycemia

Experimental group

Description:

Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.

Treatment:

Behavioral: Fear of Hypoglycemia

No Intervention

Placebo Comparator group

Description:

Serves as the control group comparator. No intervention provided.

Treatment:

Behavioral: No intervention