Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences

• Register: ClinicalTrials.gov
• Last refreshed on: 26 September 2016
• Main ID: NCT02429024
• Date of registration: 14/04/2015
• Prospective Registration: Yes
• Primary sponsor: LifeScan
• Public title: Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences
• Scientific title: Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences
• Date of first enrolment: May 2015
• Target sample size: 138
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02429024
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 4

Countries of recruitment

United Kingdom

Contacts

• Name: Mike Grady
• Affiliation: LifeScan

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female, at least 18 years old (or the legal age of consent in the
jurisdiction in which the study is taking place) to 70 years old, inclusive;

- Has an A1c =7.5 and = 11.0% 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
glyceamic recommendations (<7.0% A1c, pre-prandial capillary glucose of 3.9-7.2mmol/l
and peak post-prandial glucose of <10.0mmol/l);

- Diagnosed with T2DM or T1DM for = 3 month prior to screening;

- Currently performing SMBG at home for diabetes management decisions and willing to
test SMBG = 1 per day if subject has Type 2 diabetes and is on AHA and/or non-insulin
injectable (e.g. GLP-1) only, = 2 per day if on basal insulin or premixed insulin;
and test = 3 times per day if subject has Type 2 diabetes and is on MDI or subject
has Type 1 diabetes.

- Willing to send and receive SMS messages using a sponsor smartphone at 2 weekly
intervals throughout the study (note: this inclusion applies to all subjects
regardless of whether they are subsequently randomized to control or intervention)

- Is located in an area that can send and receive SMS messages and has access to a
phone signal to use the 3G network as required

- On a stable dose of anti-hyperglycemic agents (AHA), including oral hypoglycemics
(OAs), non-insulin injectables (e.g. GLP-1) or insulin therapy = 2 months prior to
screening; (Note: the definition of stable includes subjects who routinely
self-adjust insulin based on 'in the moment' SMBG values. Stable does not include
actual diabetes therapy changes (e.g. new oral medications, initiating insulin or
changing insulin regimen, insulin to carb ratio changes or basal to bolus insulin
progression)

- Anti-hyperglycemic agents (AHA)(OAs or GLP-1s) must be consistent with UK labeling
for the subject's insulin type;

- Willingness to not use a CGM device during the study period;

- Willingness to notify the study staff if they become pregnant during the study;

- Willingness to practice an appropriate form of birth control during the study if of
child bearing potential;

- Able to communicate (speak, read and write) in English, and able to understand and
sign the required study documents;

- Have signed an informed consent (or regional equivalent) document indicating they
understand the purpose and procedures of the study;

Exclusion Criteria:

- Is unlikely to be compliant with the currently prescribed diabetes regimen, in the
opinion of the study staff;

- Currently pregnant or planning pregnancy within the duration of the study or breast
feeding;

- 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 Systemic
corticosteroids or anti-psychotic drugs or prescription cannabinoid

- Is currently psychiatrically unstable in the opinion of the study staff

- Has known clinically significant and/or unstable medical conditions, in the opinion
of the study staff, including: Cardiovascular disease, Hematological disease, Hepatic
disease, Gastrointestinal disease, Endocrine/metabolic disorders and Neurologic
disease

- Malignant neoplasm requiring treatment in the past 5 years, other than basal
cell/squamous cell carcinoma of the skin

- History of major surgery within 6 months

- Has had any condition that in the opinion of the study staff that would complicate or
compromise the study, or the well being of the Subject

- Subject is an employee of the investigator or clinical site;



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Intervention(s)

Device: OneTouch Reveal® Mobile APP

Device: OneTouch Verio® Flex BGMS

Primary Outcome(s)

A1c change from baseline in subjects using the OneTouch Verio® Flex BGM and the OneTouch Reveal® Mobile APP system compared to subjects using only the OneTouch Verio® Flex (without Bluetooth) for 24 weeks. [Time Frame: 24 Weeks]

Secondary Outcome(s)

Quantity and percentage of glucose results within personalized glycemic ranges set by HCP at baseline. [Time Frame: 12 and 24 weeks]

A1c = 7.0% [Time Frame: 12 and 24 weeks]

Change in A1c from baseline [Time Frame: 12 and 24 weeks]

OneTouch Reveal Mobile APP interaction and usage via APP analytics over 24wks. [Time Frame: 24 weeks]

Percentage of patients that performed SMBG tests as instructed by HCP. [Time Frame: 24 weeks]

Secondary ID(s)

3132245

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bio-Kinetic Europe, Ltd.