Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848261
• Other study ID #: 37360
• Status: Completed
• Phase: N/A
• Start date: August 15, 2016
• Est. completion date: April 2019

Study information

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

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 2019
• Est. primary completion date: April 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:

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Developmental Demands
Education and training related to use of CGM in this age group
• Distress Reduction
Education and training on reducing distress
• Remote Monitoring
Education and training on the use of remote monitoring
• Fear of Hypoglycemia
Education and training on reducing fear of hypoglycemia
• No intervention
No intervention - serves as the control group

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Indiana University	Indianapolis	Indiana
United States	Stanford University	Stanford	California
United States	University of South Florida	Tampa	Florida

Sponsors (4)

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

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 6 months
Primary	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	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
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 6 months
Secondary	Diabetes Distress Scale	This measure is widely used to capture the psychological distress experienced in relation to diabetes.	Change over 6 months
Secondary	Patient Health Questionnaire 9	This is a widely used measure that captures depressive symptoms. It is reported by the participants.	Change over 6 months
Secondary	State-Trait Anxiety Inventory	This is a widely used measure of anxiety symptoms. It is reported by the participant.	Change over 6 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 6 months
Secondary	Hypoglycemic Fear Survey	People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.	Change over 6 months
Secondary	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
Secondary	Glucose Monitoring System Satisfaction Survey	This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.	Change over 6 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 6 months