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Effects of a Remote Patient Monitoring Protocol on Glycemic Control in Adolescents With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03466398
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
Vivify Health
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
This study will use a randomized, crossover design. Children aged 13-18 years who have been diagnosed with Type 1 diabetes for at least 1 year and with at least 2 Hemoglobin A1c values ≥10.0% more than 60 days apart within the past year, with the most recent HbA1c value between 10-14%, will be placed into two separate treatment groups. Group A will undergo home monitoring for 12 weeks through the use of the Vivify kit, which contains a wireless tablet with daily medication/diet/symptom questionnaires. Group B will initially continue diabetes management per standard of care, including quarterly office visits. After a period of 12 weeks, Group B will switch to the RPM protocol, while Group A will return to standard of care. Both groups will have HbA1c values checked at the 0, 3, and 6 month time periods to assess the effect of the remote monitoring protocol. Participation in the RPM protocol will involve daily completion of the Care Plan questions, as well as weekly uploads of blood glucose values using the Glooko, Inc (Mountain View, CA) application, and weekly video visits with a member of the endocrinology team that will aim to address barriers to optimal care, whether they be motivation, knowledge or other difficulties. Barriers to care will be assessed in part through the completion of knowledge and self-efficacy assessments.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Diabetes Mellitus Behavioral: Vivify Health RPM Protocol Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of a Remote Patient Monitoring Protocol on Glycemic Control in Adolescents With Type 1 Diabetes
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Intervention Arm
Patients will use the Vivify Health RPM protocol as part of their diabetes management. They required to complete the Care Plan questions on a daily basis, and will upload blood glucose readings directly to the tablet twice a day. They will also have scheduled video conferences with study team physicians or advanced practice nurses on a weekly basis, to discuss ongoing diabetes management and educational objectives.
Behavioral: Vivify Health RPM Protocol
The Vivify RPM Protocol includes a wireless tablet and glucometer/Bluetooth device that can directly upload blood glucose readings to the tablet. Patients will daily Care Plan questionnaires on the tablet, as well as upload blood glucose readings twice a day. The tablets will also be used for weekly video conferences with study investigators.

No Intervention: Control Arm
Patients in this arm will manage their diabetes at home per normal standard of care, without any extra intervention from the study investigators.



Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 3 months ]
    To determine whether 12 weeks of participation in a remote monitoring protocol utilizing remote glucose data uploads and video visits through a mobile device improves glycemic control as measured by Hemoglobin A1c in adolescents with poorly controlled Type 1 Diabetes.


Secondary Outcome Measures :
  1. Diabetes Knowledge Test 2 (DKT2) score [ Time Frame: 6 months ]

    To determine whether 12 weeks of participation in a remote monitoring protocol can improve diabetes knowledge as assessed by a questionnaire in adolescents with poorly controlled Type 1 Diabetes.

    The DKT2 contains 2 sections, with 23 questions total. The first section is general knowledge, and has 14 items. The second section is an insulin-use subscale, with 9 items. Higher scores are better for both sections.


  2. Self-Management of Type 1 Diabetes in Adolescence (SMOD-A) score [ Time Frame: 6 months ]

    Scoring:

    The first subscale (items 1-13) is Collaboration with Parents. Items 2 and 3 are reversed scored. The range of scores is 0 to 39. Higher scores indicate more collaboration.

    The second subscale is Diabetes Care Activities (items 14-28). Items 16, 21, 22, 23, 25, 26 are reversed scored. The range is 0 to 45. Higher scores indicate better performance of diabetes tasks.

    The third subscale is Diabetes Problem-Solving (items 29-35). Range of scores is 0 to 21. Higher scores indicate better problem-solving.

    The fourth subscale is Diabetes Communication (items 36-45). The range of scores is 0 to 30. Higher scores indicate more communication.

    The fifth subscale, Goals, is composed of items 1-7 of Part II of the instrument. The range of scores is 0 to 21. Higher scores indicate more goals.

    Calculating a total score is not recommended.


  3. DKA Admission Rates [ Time Frame: 6 months ]
    To evaluate whether usage of the remote monitoring protocol affects hospital admission rates for adolescents with poorly controlled Type 1 Diabetes.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 13-18 years old
  • Diagnosed with Type 1 Diabetes Mellitus >1 year ago with at least one positive diabetes autoantibody
  • Patient on multiple daily injections of insulin, with no change to insulin type within the past 3 months
  • ≥2 separate HbA1c values (at least 60 days apart) ≥10.0% in the past year, with the most recent HbA1c value ≥10.0%
  • English-Speaking (patient and at least 1 parent)
  • Patient or parents must own a smart phone or other device compatible with Glooko

Exclusion Criteria:

  • Patients on Continuous Subcutaneous Insulin Infusion
  • Diagnosed with Type 2 Diabetes or taking metformin
  • Other chronic medical condition that would be likely to affect blood glucose. Exceptions include:

    • Hypothyroidism on treatment with normal thyroid function tests
    • Asthma with no oral steroids within past 3 months
  • Unstable social situation that could compromise diabetes management or study follow-up in the judgment of the investigators

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): NCT03466398


Contacts
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Contact: Soumya Adhikari, MD 214-456-5959 SOUMYA.ADHIKARI@childrens.com
Contact: Huay-Lin Lo, MD 214-456-5959 Huay-Lin.Lo@utsouthwestern.edu

Locations
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United States, Texas
Children's Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Soumya Adhikari, MD       soumya.adhikari@childrens.com   
Principal Investigator: Soumya Adhikari, MD         
Sub-Investigator: Huay-Lin Lo, MD         
Sub-Investigator: Sneha Patel, APN         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Vivify Health
Investigators
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Principal Investigator: Soumya Adhikari, MD UT Southwestern

Publications of Results:
Other Publications:
Centers for Disease Control and Prevention., National Diabetes Statistics Report: Estimates of Diabetes and its Burden in the United States, 2014. US Department of Health and Human Services; 2014: Atlanta, GA.

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03466398     History of Changes
Other Study ID Numbers: UTSW 122016-056
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
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

Keywords provided by University of Texas Southwestern Medical Center:
Remote Patient Monitoring
Adolescents

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