Recruiting

OneTouch Flex & Reveal

Sponsor:

LifeScan

Code:

NCT03556605

Conditions

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OneTouch Reveal® Mobile APP system

Current Blood Glucose Monitor

Study Details

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

Study ID

NCT03556605

Start date

Jul 30, 2018

Status verified date

Jan, 2019

Completion date

Sep 15, 2019

Anticipated

Primary completion date

Sep 15, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Willing to receive (and send, if necessary) text messages every 2 weeks throughout the study using a smartphone. (note: this inclusion criteria applies to all subjects regardless of whether they are subsequently randomized to control or intervention arms)
  • 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

Exclusion Criteria:

  • 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
  • History of major surgery within 3 months
  • Has had any condition that in the opinion of the study staff that would complicate or compromise the study, or the wellbeing of the Subject

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Intervention Arm

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

other: Control Arm.

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.

Interventions

OneTouch Reveal® Mobile APP system

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).

Current Blood Glucose Monitor

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

Primary outcome measure

  • 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. [ Time Frame: Each subject will attend visits at Screening/Baseline, 12 weeks and 24 weeks after Baseline. ]

Central Contacts and Locations

Central contacts

Ferderico Ceppa

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

Locations

La Comunidad Hispana (LCH) Health Center

Recruiting

West Chester, Pennsylvania, United States, 19348

More Information

Sponsor

LifeScan

Last update posted

Jan 31, 2019

Last verified

Jan, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by LifeScan on 2019-01-31.