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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

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).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
Actual Study Start Date : August 15, 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Diabetes Distress Scale [ Time Frame: Change over 6 months ]
    This measure is widely used to capture the psychological distress experienced in relation to diabetes.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Regan Barley 650-736-1517 rcbarley@stanford.edu
Contact: Cari Berget 303-724-8977 cari.berget@ucdenver.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Regan C Barley    650-736-1517    rcbarley@stanford.edu   
Principal Investigator: Bruce Buckingham, MD         
Sub-Investigator: Korey Hood, PhD         
United States, Colorado
University of Colorado Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Indiana
Indiana University Active, not recruiting
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Stanford University
University of Colorado, Denver
Indiana University
Investigators
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Principal Investigator: Bruce Buckingham, MD Stanford University
Principal Investigator: Kimberly Driscoll, PhD University of Colorado, Denver
Principal Investigator: Linda DiMeglio, MD Indiana University

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Responsible Party: Korey Hood, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02848261     History of Changes
Other Study ID Numbers: 37360
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases