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Get In Touch Phase 2 (GIT-2)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Livongo for Diabetes program
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • speak English, having type 2 diabetes with two consecutive HbA1c recordings greater than 8.0% over the previous 12 months at the time of recruitment

Exclusion Criteria:

  • excluded if they were cognitively impaired, pregnant, or prisoners.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Intervention First

    Intervention Second

    Arm Description

    Participants in Intervention First were enrolled in the intervention for the first 6 months of study participation followed by a return to usual care for the following 6 months. The intervention included provision of a cellular-enable glucose meter and enrollment in the Livongo for Diabetes support program that provided both in-the-moment and scheduled support, both provided by Livongo Health Inc.

    Participants in the 'Intervention Second" received usual care for the first 6 months of study participation followed by enrollment in the intervention for the following 6 months. The intervention included provision of a cellular-enable glucose meter and enrollment in the Livongo for Diabetes support program that provided both in-the-moment and scheduled support, both provided by Livongo Health Inc.

    Outcomes

    Primary Outcome Measures

    Change in HbA1c
    The primary physiological outcome of this study was change in HbA1c during enrollment in the intervention compared to change while receiving usual care.

    Secondary Outcome Measures

    Change in Treatment Satisfaction
    The secondary outcome of this study was change in treatment satisfaction during enrollment in the intervention compared to change while receiving usual care. Treatment Satisfaction Change was measured using the Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) scale.

    Full Information

    First Posted
    December 19, 2016
    Last Updated
    July 7, 2017
    Sponsor
    University of Massachusetts, Worcester
    Collaborators
    Livongo Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03124043
    Brief Title
    Get In Touch Phase 2
    Acronym
    GIT-2
    Official Title
    Get In Touch Phase 2 - Evaluating a Diabetes Care Support Program Facilitated by Cellular-enabled Glucose Meters, a Randomized Crossover Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    May 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Massachusetts, Worcester
    Collaborators
    Livongo Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of the Get In Touch - Phase 2 (GIT-2) study was to evaluate a diabetes care support intervention facilitated by cellular-enabled glucose meters in adults with persistent poor control of type 2 diabetes.
    Detailed Description
    A 2-group randomized crossover trial comparing usual care to a diabetes care support intervention among patients with repeated HbA1c recordings greater than 8.0 percent during the previous 12 months. The intervention included 6 months of enrollment in Livongo for Diabetes, a Certified Diabetes Educator (CDE) based remote diabetes monitoring program facilitated by cellular-enabled glucose meters, with additional remote monitoring by their usual care team. HbA1c levels were recorded at enrollment and 3, 6, 9, and 12 months post enrollment. Questionnaire data were collected at baseline, 6 months, and 12 months post enrollment. Primary outcomes evaluated were change in HbA1c and treatment satisfaction at the 6 month endpoint with secondary outcomes of change in HbA1c and treatment satisfaction at the 12 month endpoint.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention First
    Arm Type
    Experimental
    Arm Description
    Participants in Intervention First were enrolled in the intervention for the first 6 months of study participation followed by a return to usual care for the following 6 months. The intervention included provision of a cellular-enable glucose meter and enrollment in the Livongo for Diabetes support program that provided both in-the-moment and scheduled support, both provided by Livongo Health Inc.
    Arm Title
    Intervention Second
    Arm Type
    Experimental
    Arm Description
    Participants in the 'Intervention Second" received usual care for the first 6 months of study participation followed by enrollment in the intervention for the following 6 months. The intervention included provision of a cellular-enable glucose meter and enrollment in the Livongo for Diabetes support program that provided both in-the-moment and scheduled support, both provided by Livongo Health Inc.
    Intervention Type
    Other
    Intervention Name(s)
    Livongo for Diabetes program
    Intervention Description
    See description in arm/group description.
    Primary Outcome Measure Information:
    Title
    Change in HbA1c
    Description
    The primary physiological outcome of this study was change in HbA1c during enrollment in the intervention compared to change while receiving usual care.
    Time Frame
    During 6-month enrollment in Intervention
    Secondary Outcome Measure Information:
    Title
    Change in Treatment Satisfaction
    Description
    The secondary outcome of this study was change in treatment satisfaction during enrollment in the intervention compared to change while receiving usual care. Treatment Satisfaction Change was measured using the Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) scale.
    Time Frame
    During 6-month enrollment in intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: speak English, having type 2 diabetes with two consecutive HbA1c recordings greater than 8.0% over the previous 12 months at the time of recruitment Exclusion Criteria: excluded if they were cognitively impaired, pregnant, or prisoners.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Thompson, MD
    Organizational Affiliation
    UMass Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33704077
    Citation
    Amante DJ, Harlan DM, Lemon SC, McManus DD, Olaitan OO, Pagoto SL, Gerber BS, Thompson MJ. Evaluation of a Diabetes Remote Monitoring Program Facilitated by Connected Glucose Meters for Patients With Poorly Controlled Type 2 Diabetes: Randomized Crossover Trial. JMIR Diabetes. 2021 Mar 11;6(1):e25574. doi: 10.2196/25574.
    Results Reference
    derived

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    Get In Touch Phase 2

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