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Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02848261
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
University of Colorado, Denver
Indiana University
Information provided by (Responsible Party):
Korey Hood, Stanford University

Tracking Information
First Submitted Date  ICMJE July 25, 2016
First Posted Date  ICMJE July 28, 2016
Last Update Posted Date May 9, 2018
Actual Study Start Date  ICMJE August 15, 2016
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02848261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
Official Title  ICMJE Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Behavioral: Developmental Demands
    Education and training related to use of CGM in this age group
  • Behavioral: Distress Reduction
    Education and training on reducing distress
  • Behavioral: Remote Monitoring
    Education and training on the use of remote monitoring
  • Behavioral: Fear of Hypoglycemia
    Education and training on reducing fear of hypoglycemia
  • Behavioral: No intervention
    No intervention - serves as the control group
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Developmental Demands
  • Experimental: Distress Reduction
    Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.
    Intervention: Behavioral: Distress Reduction
  • Experimental: Remote Monitoring
    Optimize the use of remote monitoring by focusing on situational demands and problem solving.
    Intervention: Behavioral: Remote Monitoring
  • Experimental: Fear of Hypoglycemia
    Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.
    Intervention: Behavioral: Fear of Hypoglycemia
  • Placebo Comparator: No Intervention
    Serves as the control group comparator. No intervention provided.
    Intervention: Behavioral: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2016)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Regan Barley 650-736-1517 rcbarley@stanford.edu
Contact: Cari Berget 303-724-8977 cari.berget@ucdenver.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02848261
Other Study ID Numbers  ICMJE 37360
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Korey Hood, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE
  • University of Colorado, Denver
  • Indiana University
Investigators  ICMJE
Principal Investigator: Bruce Buckingham, MD Stanford University
Principal Investigator: Kimberly Driscoll, PhD University of Colorado, Denver
Principal Investigator: Linda DiMeglio, MD Indiana University
PRS Account Stanford University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP