Get In Touch Phase 2
GIT-2
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Apr 2015
Typical duration for not_applicable diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 19, 2016
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJuly 11, 2017
July 1, 2017
1.4 years
December 19, 2016
July 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
During 6-month enrollment in Intervention
Secondary Outcomes (1)
Change in Treatment Satisfaction
During 6-month enrollment in intervention
Study Arms (2)
Intervention First
EXPERIMENTALParticipants 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.
Intervention Second
EXPERIMENTALParticipants 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.
Interventions
See description in arm/group description.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- excluded if they were cognitively impaired, pregnant, or prisoners.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Massachusetts, Worcesterlead
- Livongo Healthcollaborator
Related Publications (1)
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.
PMID: 33704077DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Thompson, MD
UMass Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Program Director
Study Record Dates
First Submitted
December 19, 2016
First Posted
April 21, 2017
Study Start
April 1, 2015
Primary Completion
September 1, 2016
Study Completion
May 1, 2017
Last Updated
July 11, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share