Diabetes Mellitus Clinical Trial
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.
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.
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