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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354286
• Other study ID #: 43167
• Status: Completed
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: March 18, 2019

Study information

• Verified date: September 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 18, 2019
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Developmental & Technological Demands
Education and training related to use of CGM in this age group
• Distress Reduction
Education and training on reducing distress
• Nutrition, Set Point, & C:I Ratio
Education and training on how to use the HCL system to dose for different kinds of foods to improve glycemic control
• Hypoglycemia management
Education and training on reducing worries of hypoglycemia
• Minimal Intervention
Minimal intervention to simulate standard care - serves as the control group

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Palo Alto	California

Sponsors (5)

Lead Sponsor	Collaborator
Stanford University	Indiana University, University of Colorado, Denver, University of South Florida, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Parent Diabetes Distress Scale	This measure is widely used to capture the psychological distress experienced in relation to diabetes.	Change over 3 months
Secondary	Patient Health Questionnaire 8	This is a widely used measure that captures depressive symptoms. It is reported by the participants.	Change over 3 months
Secondary	State-Trait Anxiety Inventory	This is a widely used measure of anxiety symptoms. It is reported by the participant.	Change over 3 months
Secondary	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
Secondary	Hypoglycemic Fear Survey - Parents	People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.	Change over 3 months
Secondary	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
Secondary	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
Secondary	Glucose Monitoring System Satisfaction Survey	This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.	Change over 3 months
Secondary	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
Secondary	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
Secondary	Health care utilization	Number of visits and calls to the diabetes care team.	Change over 3 months