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NCT03124043 Clinical Trial

Get In Touch Phase 2

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03124043
Other study ID # H00005902
Secondary ID
Status Completed
Phase N/A
First received December 19, 2016
Last updated July 7, 2017
Start date April 2015
Est. completion date May 1, 2017

Study information
Verified date July 2017
Source University of Massachusetts, Worcester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date May 1, 2017
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Livongo for Diabetes program
See description in arm/group description.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of Massachusetts, Worcester Livongo Health

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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