Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT03556605
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03556605
Study Brief:
Protocol Section:
NCT03556605