Get In Touch Phase 2 (GIT-2)

Get In Touch Phase 2 - Evaluating a Diabetes Care Support Program Facilitated by Cellular-enabled Glucose Meters, a Randomized Crossover Trial

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Livongo for Diabetes program

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention First; 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.	Other: Livongo for Diabetes program; See description in arm/group description.
EXPERIMENTAL: Intervention Second; 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.	Other: Livongo for Diabetes program; See description in arm/group description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During 6-month enrollment in intervention

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Livongo Health
• Investigators: Principal Investigator: Michael Thompson, MD, UMass Medical School

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): May 1, 2017

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (ACTUAL): April 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 7, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: H00005902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO