NCT02429024

Brief Summary

Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences with patients with Type I and Type II diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus

Timeline
Completed

Started May 2015

Shorter than P25 for phase_4 diabetes-mellitus

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

April 14, 2015

Last Update Submit

September 12, 2016

Conditions

Diabetes Mellitus

Keywords

Diabetes MellitusA1c

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 Weeks

Secondary Outcomes (5)

  • A1c ≤ 7.0%

    12 and 24 weeks

  • Change in A1c from baseline

    12 and 24 weeks

  • Quantity and percentage of glucose results within personalized glycemic ranges set by HCP at baseline.

    12 and 24 weeks

  • Percentage of patients that performed SMBG tests as instructed by HCP.

    24 weeks

  • OneTouch Reveal Mobile APP interaction and usage via APP analytics over 24wks.

    24 weeks

Other Outcomes (3)

  • Change in patient satisfaction ( DTSQ survey)

    Baseline and 24 weeks

  • Number of SMS messages sent by the HCP

    24 weeks

  • Healthcare efficiency survey by the HCP

    12 and 24 weeks

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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 APPDevice: OneTouch Verio® Flex BGMS

Interventions

OneTouch Reveal® Mobile APPDEVICE

Diabetes management application for use on a mobile phone.

Intervention
OneTouch Verio® Flex BGMSDEVICE

Blood Glucose Monitoring System (BGMS)

Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

BioKinetic Europe Ltd

Belfast, Antrim, BT2 7BA, United Kingdom

Location

Diabetes Centre, Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

NHS Lothian

Edinburgh, EH16 4SA, United Kingdom

Location

Highland Diabetes Institute

Inverness, IV2 3JH, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 30291092DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mike Grady

    LifeScan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 29, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations

GB(4)