Supporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System

Study Overview
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Brief Summary
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This study will examine the impact of a closed-loop insulin delivery system intervention on health and psychological outcomes in families with young children with Type 1 Diabetes (T1D).

Official Title
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Supporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Developmental & Technological Demands
* Behavioral: Distress Reduction
* Behavioral: Nutrition, Set Point, & C:I Ratio
* Behavioral: Hypoglycemia management
* Behavioral: Minimal 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 since enrollment in the CEP 302 Trial: Diagnosis of type 1 diabetes according to ADA diagnostic criteria Time since diagnosis of at least six months Age between 2.00 and 6.99 years at enrollment Parental consent to participate in the study Completion of the CEP 302 Trial and in the continuation phase of the Medtronic CEP 302 Trial using the Medtronic MiniMed 670G pump with Enlite3 sensor. 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. The presence of any of the following is an exclusion for the study (since enrollment in the CEP 302 Trial): 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: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Developmental & Technological 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. Identify and troubleshoot barriers to keeping young children in Auto Mode. | Behavioral: Developmental & Technological 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: Nutrition, Set Point, & C:I Ratio<br>Provide education on a variety of properties of food and how they affect blood glucose levels. Optimize the use of carbohydrate to Insulin ratios, insulin duration of action, and use of temporary target glucose set point in the 670G pump and the Quick bolus feature to gain better glycemic control. | Behavioral: Nutrition, Set Point, & C:I Ratio<br>* Education and training on how to use the HCL system to dose for different kinds of foods to improve glycemic control<br>|
| Experimental: Hypoglycemia management<br>Focus on hypoglycemia management to avoid hyperglycemia, review fear of hypoglycemia | Behavioral: Hypoglycemia management<br>* Education and training on reducing worries of hypoglycemia<br>|
| Placebo Comparator: Minimal Intervention<br>A short communication detailing the percentage of time spent in range and in Auto Mode and if the goals have been met. | Behavioral: Minimal Intervention<br>* Minimal intervention to simulate standard care - 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 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin 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 3 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 3 months | 
| Parent Diabetes Distress Scale | This measure is widely used to capture the psychological distress experienced in relation to diabetes. | Change over 3 months | 
| Patient Health Questionnaire 8 | This is a widely used measure that captures depressive symptoms. It is reported by the participants. | Change over 3 months | 
| State-Trait Anxiety Inventory | This is a widely used measure of anxiety symptoms. It is reported by the participant. | Change over 3 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 3 months | 
| Hypoglycemic Fear Survey - Parents | People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants. | Change over 3 months | 
| Hypoglycemia Confidence Questionnaire | Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations. | Change over 3 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 3 months | 
| Glucose Monitoring System Satisfaction Survey | This a measure used to capture overall satisfaction with glucose monitoring devices used by participants. | Change over 3 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 3 months | 
| Diabetes management behaviors | Amount of time spent in Auto Mode; blood glucose monitoring frequency (by meter download); adherence to pump boluses. It is objectively reported by device downloads. | Change over 3 months | 
| Health care utilization | Number of visits and calls to the diabetes care team. | Change over 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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670G, Hybrid closed-loop system, pediatric