Tu Salud (Your Health) Randomized Control Study in Patients With Diabetes Using a Mobile App.
Status unconfirmed · Not applicable
Conditions studied: Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT03556605
- Run by
- LifeScan
- People needed
- 100
- Starts
- 2018-07-30
- Expected to finish
- 2019-09-15
- Last updated by the study team
- 2019-01-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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
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
- 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
Where it is running
- La Comunidad Hispana (LCH) Health Center — West Chester, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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