Get In Touch Phase 2

NCT ID: NCT03124043

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-05-01

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Livongo for Diabetes program

Intervention Type: OTHER

See description in arm/group description.

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.

Group Type: EXPERIMENTAL

Livongo for Diabetes program

Intervention Type: OTHER

See description in arm/group description.

Interventions

Livongo for Diabetes program

See description in arm/group description.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Livongo Health

INDUSTRY

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Daniel Amante

Program Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Thompson, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Medical School

References

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.

Reference Type: DERIVED

PMID: 33704077 (View on PubMed)

Other Identifiers

H00005902

Identifier Type: -

Identifier Source: org_study_id