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Status unknownNCT03556605Updated Jan 31, 2019

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

An interventional study of OneTouch Reveal® Mobile APP system and Current Blood Glucose Monitor in Diabetes Mellitus, sponsored by LifeScan. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-31.

Sponsored by LifeScan (formerly part of Johnson & Johnson) · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This is a parallel arm, open-label, randomized controlled, partial cross-over study. Subjects will be randomized into intervention group or control group in a 2:1 ratio. Intervention group will use the Flex blood glucose meter and OneTouch Reveal Mobile App and receive text messages every 2 weeks from the Health Care Professional for 12 weeks. The intervention group will continue under the same conditions until 24 weeks to explore durability of effects. The control group will use their own blood glucose meter without connectivity to a diabetes app for the first 12 weeks of the study. At that point, control group subjects will cross-over to the same treatment as the intervention group for an additional 12 weeks.

A target of 100 subjects will be enrolled in the Intervention arm and a target of 50 subjects will be enrolled in the Control arm. Randomization will be stratified based on type of diabetes (Type 1 or Type 2) and A1c (above or below 9.0%). Each subject will attend visits at Screening/Baseline, 12 weeks and 24 weeks after Baseline. In most cases, Screening and Baseline will occur on the same day.

Study Periods

The study will be conducted in the following periods:

Visit 1 (Screening/Baseline): All screening procedures will be performed including informed consent, demographics, medical history, a capillary blood draw for POC A1c determination and evaluation of entrance criteria. If subject A1c meets inclusion criteria and subject meets all other inclusion criteria and none of the exclusion criteria, subject will be randomized into one of two arms via randomization scheme. The time of randomization becomes Day 1.

Visit 2 (Week 12 ± 7 days): A capillary blood draw will be performed for measurement of POC A1c. The HCP will discuss diabetes management progress with all subjects: for the control group based on their own meter data; for the intervention group, the HCP will download SMBG data from Flex meters and discuss diabetes management based on OTRM APP and Flex meter information. The HCP will review and consider if the glucose range limits on the Flex meter and/or OTRM need to be updated. Intervention subjects will continue in the same group for an additional 12 weeks. Control subjects will be switched to Flex and OTRM for 12 weeks.

Visit 3 (Week 24 ± 7 days): A capillary blood draw will be performed for measurement of POC A1c. The HCP will download SMBG data from all Flex meters. Subjects will return study materials.

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

LifeScan is the lead sponsor of 15 studies on the registry; none are open to participants now.

First submitted before LifeScan left Johnson & Johnson.

Browse LifeScan studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Intervention Arm

    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

  • 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.

    Other: Current Blood Glucose Monitor

Interventions

  • OtherOneTouch 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).

  • OtherCurrent Blood Glucose Monitor

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

06

What researchers measure

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).

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

07

Study locations

1 of 1 sites recruiting
  • La Comunidad Hispana (LCH) Health Center
    West Chester, Pennsylvania 19348, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2018 (actual). Primary completion is estimated for Sep 2019, 13 months after the start.

Of 192 industry-sponsored interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 29. This study's planned 13 months is close to that.

Counting every sponsor, half of 2,388 studies reached it within 20 months; a quarter within 9 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
May 29, 2018
First posted
Jun 14, 2018
StartActual
Jul 30, 2018
Primary completionEst.
Sep 15, 2019
CompletionEst.
Sep 15, 2019
Last update
Jan 31, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03556605
Lead sponsor
LifeScan
Responsible party
Sponsor
First posted
Jun 14, 2018
Start date
Jul 30, 2018
Primary completion
Sep 15, 2019 (estimated)
Completion
Sep 15, 2019 (estimated)
Last update
Jan 31, 2019

Study contacts

Ferderico Ceppa
Contact
fceppa@lchps.org
+1 610-384-6550
Frederico Ceppa
principal investigator · La Comunidad Hispana Health Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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