Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences

September 12, 2016 updated by: LifeScan
Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences with patients with Type I and Type II diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to demonstrate improved A1c in study subjects with type 1 and type 2 diabetes using the OneTouch Verio® Flex BGM and the OneTouch Reveal® Mobile APP system over a period of 24 weeks, compared to subjects using the OneTouch Verio® Flex BGM.

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Diabetes Centre, Heartlands Hospital
      • Edinburgh, United Kingdom, EH16 4SA
        • NHS Lothian
      • Inverness, United Kingdom, IV2 3JH
        • Highland Diabetes Institute
    • Antrim
      • Belfast, Antrim, United Kingdom, BT2 7BA
        • BioKinetic Europe Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Subjects with type 1 and type 2 diabetes will be provided with the OneTouch Verio® Flex BGM system only over a period of 24 weeks.
Experimental: Intervention
Subjects with type 1 and type 2 diabetes will be provided with the OneTouch Verio® Flex BGM and the OneTouch Reveal® Mobile APP system over a period of 24 weeks.
Device: OneTouch Reveal® Mobile APP
Diabetes management application for use on a mobile phone.
Device: OneTouch Verio® Flex BGMS
Blood Glucose Monitoring System (BGMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
A1c ≤ 7.0%
Time Frame: 12 and 24 weeks
12 and 24 weeks
Change in A1c from baseline
Time Frame: 12 and 24 weeks
12 and 24 weeks
Quantity and percentage of glucose results within personalized glycemic ranges set by HCP at baseline.
Time Frame: 12 and 24 weeks
12 and 24 weeks
Percentage of patients that performed SMBG tests as instructed by HCP.
Time Frame: 24 weeks
24 weeks
OneTouch Reveal Mobile APP interaction and usage via APP analytics over 24wks.
Time Frame: 24 weeks
24 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Change in patient satisfaction ( DTSQ survey)
Time Frame: Baseline and 24 weeks
Baseline and 24 weeks
Number of SMS messages sent by the HCP
Time Frame: 24 weeks
24 weeks
Healthcare efficiency survey by the HCP
Time Frame: 12 and 24 weeks
12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeScan

Collaborators

Bio-Kinetic Europe, Ltd.

Investigators

  • Study Director: Mike Grady, LifeScan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3132245

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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