Get In Touch Phase 2

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Livongo for Diabetes program

• Registration Number: NCT03124043
• Lead Sponsor: University of Massachusetts, Worcester

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.

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2016-09
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-21
• Study Completion: 2017-05-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-07
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention First	Livongo for Diabetes program	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.
Intervention Second	Livongo for Diabetes program	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.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	During 6-month enrollment in Intervention	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

Name	Time	Method
Change in Treatment Satisfaction	During 6-month enrollment in intervention	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.