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Increasing Use of Continuous Glucose Monitors in Publicly-insured Youth 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: NCT03297762
Recruitment Status : Terminated (Enrollment challenges)
First Posted : September 29, 2017
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Darrell M Wilson, Stanford University

Brief Summary:
To use an enhanced continuous glucose monitor (CGM) experience, including an automated CGM-electronic health record (EHR) data integration system, proactive interventions, and gamification techniques, to increase CGM use among publicly-insured youth with type 1 diabetes (T1D).

Condition or disease Intervention/treatment Phase
Type1diabetes Behavioral: gamification Behavioral: Use of Dexcom G5 Not Applicable

Detailed Description:
The investigators will use an automated data integration system to monitor hours per week the CGM is worn and target interventions/troubleshooting techniques as needed. The investigators will use gamification techniques (i.e. ability to gain points and achieve small rewards) to help encourage CGM use and potentially improve glycemic control in this at-risk population.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Improving Adherence to Continuous Glucose Monitors in Publicly-insured Youth With Type 1 Diabetes
Actual Study Start Date : May 7, 2018
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Gamification
Use of continuous glucose monitor (Dexcom G5) with proactive intervention and incentives for time in use.
Behavioral: gamification
incentives/rewards and contact between standard visits

Behavioral: Use of Dexcom G5
Dexcom G5 continuous glucose monitor

Active Comparator: Standard care
Use of continuous glucose monitor (Dexcom G5) per usual care.
Behavioral: Use of Dexcom G5
Dexcom G5 continuous glucose monitor




Primary Outcome Measures :
  1. CGM use [ Time Frame: baseline to 6 months ]
    amount of time per week CGM is used


Secondary Outcome Measures :
  1. Hgb A1c [ Time Frame: baseline to 6 months ]
    glycemic control as measured by Hgb A1c



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 1 diabetes for more than 6 months
  • on insulin pump or multiple daily injections without plans to change modality in next 6 months
  • insured by CCS or Medi-Cal
  • receiving care at Lucile Packard Children's Hospital or Stanford Children's Health outpatient clinics
  • English or Spanish-speaking

Exclusion Criteria:

  • major illness or condition that may alter glucose control or ability to complete the study including pregnancy, cystic fibrosis, cancer, liver disease, history of transplant, or hemoglobinopathy
  • current oral glucocorticoid use
  • prior use of a CGM system
  • hemoglobin A1C <7.5% or >12%
  • no wireless internet access

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): NCT03297762


Locations
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United States, California
Stanford Children's
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Maria Chang, MD Stanford University
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Responsible Party: Darrell M Wilson, Professor of Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT03297762    
Other Study ID Numbers: IRB-36423
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: 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