Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

Study Overview
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Brief Summary
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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).

Official Title
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Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Developmental Demands
* Behavioral: Distress Reduction
* Behavioral: Remote Monitoring
* Behavioral: Fear of Hypoglycemia
* Behavioral: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Developmental Demands<br>Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving. | Behavioral: Developmental Demands<br>* Education and training related to use of CGM in this age group<br>|
| Experimental: Distress Reduction<br>Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support. | Behavioral: Distress Reduction<br>* Education and training on reducing distress<br>|
| Experimental: Remote Monitoring<br>Optimize the use of remote monitoring by focusing on situational demands and problem solving. | Behavioral: Remote Monitoring<br>* Education and training on the use of remote monitoring<br>|
| Experimental: Fear of Hypoglycemia<br>Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control. | Behavioral: Fear of Hypoglycemia<br>* Education and training on reducing fear of hypoglycemia<br>|
| Placebo Comparator: No Intervention<br>Serves as the control group comparator. No intervention provided. | Behavioral: No intervention<br>* No intervention - serves as the control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in blood glucose range | 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. | Change over 6 months | 
| Pediatric Quality of Life Inventory | 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. | Change over 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1c | 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. | Change over 6 months | 
| Problem Areas in Diabetes | 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. | Change over 6 months | 
| Diabetes Distress Scale | This measure is widely used to capture the psychological distress experienced in relation to diabetes. | Change over 6 months | 
| Patient Health Questionnaire 9 | This is a widely used measure that captures depressive symptoms. It is reported by the participants. | Change over 6 months | 
| State-Trait Anxiety Inventory | This is a widely used measure of anxiety symptoms. It is reported by the participant. | Change over 6 months | 
| Pittsburgh Sleep Quality Index | This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants. | Change over 6 months | 
| Hypoglycemic Fear Survey | People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants. | Change over 6 months | 
| Hypoglycemic Confidence Questionnaire | Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations. | Change over 6 months | 
| Glucose Monitoring System Satisfaction Survey | This a measure used to capture overall satisfaction with glucose monitoring devices used by participants. | Change over 6 months | 
| General and diabetes-specific technology use | This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices. | Change over 6 months |