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Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02429024
First Posted: April 29, 2015
Last Update Posted: September 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bio-Kinetic Europe, Ltd.
Information provided by (Responsible Party):
LifeScan
  Purpose
Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences with patients with Type I and Type II diabetes.

Condition Intervention Phase
Diabetes Mellitus Device: OneTouch Reveal® Mobile APP Device: OneTouch Verio® Flex BGMS Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences

Further study details as provided by LifeScan:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 138
Study Start Date: May 2015
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429024


Locations
United Kingdom
BioKinetic Europe Ltd
Belfast, Antrim, United Kingdom, BT2 7BA
Diabetes Centre, Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
NHS Lothian
Edinburgh, United Kingdom, EH16 4SA
Highland Diabetes Institute
Inverness, United Kingdom, IV2 3JH
Sponsors and Collaborators
LifeScan
Bio-Kinetic Europe, Ltd.
Investigators
Study Director: Mike Grady LifeScan
  More Information

Responsible Party: LifeScan
ClinicalTrials.gov Identifier: NCT02429024     History of Changes
Other Study ID Numbers: 3132245
First Submitted: April 14, 2015
First Posted: April 29, 2015
Last Update Posted: September 14, 2016
Last Verified: September 2016

Keywords provided by LifeScan:
Diabetes Mellitus
A1c

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases