Tu Salud (Your Health) Randomized Control Study in Patients With Diabetes Using a Mobile App.

NCT03556605 | Unknown

• 1 other identifier: PR3170365
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study seeks to demonstrate the clinical value and user acceptance of the Bluetooth enabled OneTouch Verio® Flex meter (Flex) used in combination with the OneTouch Reveal® Mobile APP to support overall diabetes care, glycemic control and patient reported outcomes in patients with diabetes in an undeserved population.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in A1c from baseline at 12 weeks in intervention group compared to control group. At this point, control group subjects will cross-over to the same treatment as the intervention group for an additional 12 weeks.

  The primary objective is to demonstrate improved glycemic control in people with diabetes using the OneTouch Verio® Flex Blood Glucose Monitors and the OneTouch Reveal® Mobile APP system (intervention group) compared to subjects continuing to use their own Blood Glucose Monitor without connection to mobile diabetes apps (control group).

  Each subject will attend visits at Screening/Baseline, 12 weeks and 24 weeks after Baseline.

Study Arms (2)

Intervention Arm

OTHER

A target of 100 subjects will be enrolled in the Intervention arm using the OneTouch Reveal® Mobile APP system

Other: OneTouch Reveal® Mobile APP system

Control Arm.

OTHER

A target of 50 subjects will be enrolled in the Control intervention arm. Subjects continue to use their current Blood Glucose Monitor without connection to mobile diabetes apps.

Other: Current Blood Glucose Monitor

Interventions

OneTouch Reveal® Mobile APP system OTHER

Improved glycemic control in people with diabetes using the OneTouch Verio® Flex Blood Glucose Monitor and the OneTouch Reveal® Mobile APP system (intervention group) compared to subjects continuing to use their own Blood Glucose Monitor without connection to mobile diabetes apps (control group).

Intervention Arm

Current Blood Glucose Monitor OTHER

Subjects continue to use current Blood Glucose Monitor without connection to mobile diabetes apps.

Control Arm.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female , at least 18 years old.
• Has an A1c ≥7.5 at screening visit
• It is medically appropriate in the opinion of the investigator for the Subject to attempt to achieve a level of glycemic control in line with the ADA guidelines on glycemic recommendations (\<7.0% A1c, pre-prandial capillary glucose of 70-130 mg/dl and peak post-prandial glucose of \<180 mg/dl)
• Diagnosed with T2D or T1D for ≥ 3 month before screening
• Currently performing SMBG at home for diabetes management decisions and willing to perform SMBG ≥ 1 per day if subject has T2D and is on oral antihyperglycemic (AHA) agents and/or non-insulin injectable (e.g. GLP-1) only; test ≥ 2 times per day if on basal insulin or premixed insulin; and test ≥ 3 times per day if subject has T2D and is on multiple daily injections (MDI) or subject has T1D
• Is in an area that can send and receive text messages and has access to a phone signal to use the network as required
• Willingness to notify the study staff if they become pregnant during the study
• Able to communicate in English or Spanish, and able to understand and sign the required study documents;
• Sign an informed consent document indicating they understand the purpose and procedures of the study

You may not qualify if:

• Unlikely to be compliant with the currently prescribed diabetes regimen, in the opinion of the study staff
• Subject is pregnant
• Currently using OneTouch Verio® Flex at home for routine glucose testing
• Currently using OneTouch Reveal app
• Currently using a continuous glucose monitor (CGM) or insulin pump
• Has unstable (rapidly progressing) retinopathy that in the opinion of the study staff may require surgical treatment (including laser photocoagulation) during the study
• Is currently on or received treatment during the past 3 months with the following medications: Systemic corticosteroids or anti-psychotic drugs
• Is currently psychiatrically unstable in the opinion of the study staff
• Has known clinically significant and/or unstable medical conditions which, in the opinion of the study staff, could interfere with participation in the study, including:
• Cardiovascular disease
• Hematological disease
• Hepatic disease.
• Gastrointestinal disease
• Endocrine/metabolic disorders
• Neurologic disease

Sponsors & Collaborators

• LifeScan: lead

Study Sites (1)

La Comunidad Hispana (LCH) Health Center

West Chester, Pennsylvania, 19348, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Frederico Ceppa

  La Comunidad Hispana Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferderico Ceppa

CONTACT

+1 610-384-6550; fceppa@lchps.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 14, 2018
• Study Start: July 30, 2018
• Primary Completion: September 15, 2019
• Study Completion: September 15, 2019
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)