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

Stanford University

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Behavioral: Minimal Intervention; Behavioral: Developmental & Technological Demands; Behavioral: Hypoglycemia management; Behavioral: Nutrition, Set Point, & C:I Ratio; Behavioral: Distress Reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT03354286

43167

Details and patient eligibility

About

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).

Enrollment: 26 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 since enrollment in the CEP 302 Trial:

1. Diagnosis of type 1 diabetes according to ADA diagnostic criteria
2. Time since diagnosis of at least six months
3. Age between 2.00 and 6.99 years at enrollment
4. Parental consent to participate in the study
5. 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:

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.

The presence of any of the following is an exclusion for the study (since enrollment in the CEP 302 Trial):

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: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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26 participants in 5 patient groups, including a placebo group

Developmental & Technological 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. Identify and troubleshoot barriers to keeping young children in Auto Mode.

Treatment:

Behavioral: Developmental & Technological Demands

Distress Reduction

Experimental group

Description:

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

Treatment:

Behavioral: Distress Reduction

Nutrition, Set Point, & C:I Ratio

Experimental group

Description:

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.

Treatment:

Behavioral: Nutrition, Set Point, & C:I Ratio

Hypoglycemia management

Experimental group

Description:

Focus on hypoglycemia management to avoid hyperglycemia, review fear of hypoglycemia

Treatment:

Behavioral: Hypoglycemia management

Minimal Intervention

Placebo Comparator group

Description:

A short communication detailing the percentage of time spent in range and in Auto Mode and if the goals have been met.

Treatment:

Behavioral: Minimal Intervention