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Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Developmental Demands

Distress Reduction

Remote Monitoring

Fear of Hypoglycemia

No intervention

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford University
University of Colorado
University of South Florida
Indiana University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Developmental Demands

Distress Reduction

Remote Monitoring

Fear of Hypoglycemia

No Intervention

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

Optimize the use of remote monitoring by focusing on situational demands and problem solving.

Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.

Serves as the control group comparator. No intervention provided.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

Diabetes Distress Scale

This measure is widely used to capture the psychological distress experienced in relation to diabetes.

Patient Health Questionnaire 9

This is a widely used measure that captures depressive symptoms. It is reported by the participants.

State-Trait Anxiety Inventory

This is a widely used measure of anxiety symptoms. It is reported by the participant.

Pittsburgh Sleep Quality Index

This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.

Hypoglycemic Fear Survey

People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.

Hypoglycemic Confidence Questionnaire

Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations.

Glucose Monitoring System Satisfaction Survey

This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.

General and diabetes-specific technology use

This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.

Full Information

NCT ID

NCT02848261

First Posted

July 25, 2016

Last Updated

November 7, 2019

Sponsor

Stanford University

Collaborators

University of Colorado, Denver, Indiana University, University of South Florida

1. Study Identification

Unique Protocol Identification Number

NCT02848261

Brief Title

Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

Official Title

Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

August 15, 2016 (Actual)

Primary Completion Date

April 2019 (Actual)

Study Completion Date

April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

University of Colorado, Denver, Indiana University, University of South Florida

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Developmental Demands

Arm Type

Experimental

Arm Description

Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving.

Arm Title

Distress Reduction

Arm Type

Experimental

Arm Description

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

Arm Title

Remote Monitoring

Arm Type

Experimental

Arm Description

Optimize the use of remote monitoring by focusing on situational demands and problem solving.

Arm Title

Fear of Hypoglycemia

Arm Type

Experimental

Arm Description

Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.

Arm Title

No Intervention

Arm Type

Placebo Comparator

Arm Description

Serves as the control group comparator. No intervention provided.

Intervention Type

Behavioral

Intervention Name(s)

Developmental Demands

Intervention Description

Education and training related to use of CGM in this age group

Intervention Type

Behavioral

Intervention Name(s)

Distress Reduction

Intervention Description

Education and training on reducing distress

Intervention Type

Behavioral

Intervention Name(s)

Remote Monitoring

Intervention Description

Education and training on the use of remote monitoring

Intervention Type

Behavioral

Intervention Name(s)

Fear of Hypoglycemia

Intervention Description

Education and training on reducing fear of hypoglycemia

Intervention Type

Behavioral

Intervention Name(s)

No intervention

Intervention Description

No intervention - serves as the control group

Primary Outcome Measure Information:

Title

Time spent in blood glucose range

Description

Time Frame

Change over 6 months

Title

Pediatric Quality of Life Inventory

Description

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.

Time Frame

Change over 6 months

Secondary Outcome Measure Information:

Title

A1c

Description

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.

Time Frame

Change over 6 months

Title

Problem Areas in Diabetes

Description

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.

Time Frame

Change over 6 months

Title

Diabetes Distress Scale

Description

This measure is widely used to capture the psychological distress experienced in relation to diabetes.

Time Frame

Change over 6 months

Title

Patient Health Questionnaire 9

Description

This is a widely used measure that captures depressive symptoms. It is reported by the participants.

Time Frame

Change over 6 months

Title

State-Trait Anxiety Inventory

Description

This is a widely used measure of anxiety symptoms. It is reported by the participant.

Time Frame

Change over 6 months

Title

Pittsburgh Sleep Quality Index

Description

This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.

Time Frame

Change over 6 months

Title

Hypoglycemic Fear Survey

Description

People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.

Time Frame

Change over 6 months

Title

Hypoglycemic Confidence Questionnaire

Description

Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations.

Time Frame

Change over 6 months

Title

Glucose Monitoring System Satisfaction Survey

Description

This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.

Time Frame

Change over 6 months

Title

General and diabetes-specific technology use

Description

This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.

Time Frame

Change over 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce Buckingham, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kimberly Driscoll, PhD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Linda DiMeglio, MD

Organizational Affiliation

Indiana University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Henry Rodriguez, MD

Organizational Affiliation

University of South Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

University of Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33620

Country

United States

Facility Name

Indiana University

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

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