Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02848261|
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : November 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Behavioral: Developmental Demands Behavioral: Distress Reduction Behavioral: Remote Monitoring Behavioral: Fear of Hypoglycemia Behavioral: No intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes|
|Actual Study Start Date :||August 15, 2016|
|Actual Primary Completion Date :||April 2019|
|Actual Study Completion Date :||April 2019|
Experimental: Developmental Demands
Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving.
Behavioral: Developmental Demands
Education and training related to use of CGM in this age group
Experimental: Distress Reduction
Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.
Behavioral: Distress Reduction
Education and training on reducing distress
Experimental: Remote Monitoring
Optimize the use of remote monitoring by focusing on situational demands and problem solving.
Behavioral: Remote Monitoring
Education and training on the use of remote monitoring
Experimental: Fear of Hypoglycemia
Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.
Behavioral: Fear of Hypoglycemia
Education and training on reducing fear of hypoglycemia
Placebo Comparator: No Intervention
Serves as the control group comparator. No intervention provided.
Behavioral: No intervention
No intervention - serves as the control group
- Time spent in blood glucose range [ Time Frame: Change over 6 months ]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 [ Time Frame: Change over 6 months ]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.
- A1c [ Time Frame: Change over 6 months ]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 [ Time Frame: Change over 6 months ]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 [ Time Frame: Change over 6 months ]This measure is widely used to capture the psychological distress experienced in relation to diabetes.
- Patient Health Questionnaire 9 [ Time Frame: Change over 6 months ]This is a widely used measure that captures depressive symptoms. It is reported by the participants.
- State-Trait Anxiety Inventory [ Time Frame: Change over 6 months ]This is a widely used measure of anxiety symptoms. It is reported by the participant.
- Pittsburgh Sleep Quality Index [ Time Frame: Change over 6 months ]This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.
- Hypoglycemic Fear Survey [ Time Frame: Change over 6 months ]People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.
- Hypoglycemic Confidence Questionnaire [ Time Frame: Change over 6 months ]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 [ Time Frame: Change over 6 months ]This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.
- General and diabetes-specific technology use [ Time Frame: Change over 6 months ]This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848261
|United States, California|
|Stanford, California, United States, 94305|
|United States, Colorado|
|University of Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33620|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Bruce Buckingham, MD||Stanford University|
|Principal Investigator:||Kimberly Driscoll, PhD||University of Colorado, Denver|
|Principal Investigator:||Linda DiMeglio, MD||Indiana University|
|Principal Investigator:||Henry Rodriguez, MD||University of South Florida|