Diabetes MellitusNCT03556605
Tu Salud (Your Health) Randomized Control Study in Patients With Diabetes Using a Mobile App.
A study testing OneTouch Reveal® Mobile APP system and Current Blood Glucose Monitor in people with Diabetes Mellitus, run by LifeScan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- OneTouch Reveal® Mobile APP system and Current Blood Glucose Monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2018to 15 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
La Comunidad Hispana (LCH) Health Center
West Chester, Pennsylvania, 19348
About this study
Official title: Tu Salud Randomized Controlled Partial Cross-over Study in Patients With Diabetes in an Underserved Population
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.
- Conditions
- Diabetes Mellitus
- Being tested
- OneTouch Reveal® Mobile APP system, Current Blood Glucose Monitor
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OneTouch Reveal® Mobile APP systemOther
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 MonitorOther
Subjects continue to use current Blood Glucose Monitor without connection to mobile diabetes apps.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Other | A target of 100 subjects will be enrolled in the Intervention arm using the OneTouch Reveal® Mobile APP system Receives: 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. Receives: Other: Current Blood Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Each subject will attend visits at Screening/Baseline, 12 weeks and 24 weeks after Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start30 Jul 2018
- Primary completion15 Sep 2019 (estimated)
- Study completion15 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeScan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederico Ceppa, Principal investigator, La Comunidad Hispana Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556605
- Sponsor's protocol ID
- PR3170365
- Status last verified
- Jan 2019
- First submitted
- 29 May 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tu Salud Randomized Controlled Partial Cross-over Study in Patients With Diabetes in an Underserved Population
- ClinicalTrials.gov ID
- NCT03556605
- Acronym / sponsor ID
- PR3170365
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- LifeScanIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 15 Sep 2019 (estimated)
- Study completion
- 15 Sep 2019 (estimated)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Other | Other: OneTouch Reveal® Mobile APP systemA target of 100 subjects will be enrolled in the Intervention arm using the OneTouch Reveal® Mobile APP system |
| Control Arm. | Other | Other: Current Blood Glucose MonitorA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OneTouch Reveal® Mobile APP systemImproved 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). | Other | Intervention Arm |
| Current Blood Glucose MonitorSubjects continue to use current Blood Glucose Monitor without connection to mobile diabetes apps. | Other | Control Arm. |
Primary outcome
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.
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederico Ceppa principal investigator
La Comunidad Hispana Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OneTouch Reveal® Mobile APP system and Current Blood Glucose Monitor in people with Diabetes Mellitus, run by LifeScan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ferderico Ceppa (+1 610-384-6550, fceppa@lchps.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.