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Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences

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ClinicalTrials.gov Identifier: NCT02429024
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : September 14, 2016
Sponsor:
Collaborator:
Bio-Kinetic Europe, Ltd.
Information provided by (Responsible Party):
LifeScan

Tracking Information
First Submitted Date  ICMJE April 14, 2015
First Posted Date  ICMJE April 29, 2015
Last Update Posted Date September 14, 2016
Study Start Date  ICMJE May 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2015)
  • A1c ≤ 7.0% [ Time Frame: 12 and 24 weeks ]
  • Change in A1c from baseline [ Time Frame: 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 ]
  • Percentage of patients that performed SMBG tests as instructed by HCP. [ Time Frame: 24 weeks ]
  • OneTouch Reveal Mobile APP interaction and usage via APP analytics over 24wks. [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 23, 2015)
  • Change in patient satisfaction ( DTSQ survey) [ Time Frame: Baseline and 24 weeks ]
  • Number of SMS messages sent by the HCP [ Time Frame: 24 weeks ]
  • Healthcare efficiency survey by the HCP [ Time Frame: 12 and 24 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences
Official Title  ICMJE Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences
Brief Summary Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences with patients with Type I and Type II diabetes.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • Device: OneTouch Reveal® Mobile APP
    Diabetes management application for use on a mobile phone.
  • Device: OneTouch Verio® Flex BGMS
    Blood Glucose Monitoring System (BGMS)
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: OneTouch Reveal® Mobile APP
    • Device: OneTouch Verio® Flex BGMS
Publications * Grady M, Katz LB, Cameron H, Levy BL. Diabetes App-Related Text Messages From Health Care Professionals in Conjunction With a New Wireless Glucose Meter With a Color Range Indicator Improves Glycemic Control in Patients With Type 1 and Type 2 Diabetes: Randomized Controlled Trial. JMIR Diabetes. 2017 Aug 7;2(2):e19. doi: 10.2196/diabetes.7454.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2016)
138
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2015)
142
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02429024
Other Study ID Numbers  ICMJE 3132245
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LifeScan
Study Sponsor  ICMJE LifeScan
Collaborators  ICMJE Bio-Kinetic Europe, Ltd.
Investigators  ICMJE
Study Director: Mike Grady LifeScan
PRS Account LifeScan
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP