Diabetes MellitusPhase 4NCT02429024
Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences
A Phase 4 study testing OneTouch Reveal® Mobile APP and OneTouch Verio® Flex BGMS in people with Diabetes Mellitus, run by LifeScan at 4 sites in United Kingdom.
Trial summary
Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences with patients with Type I and Type II diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- OneTouch Reveal® Mobile APP and OneTouch Verio® Flex BGMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- May 2015to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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;
Who cannot join
- 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
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- 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;
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
BioKinetic Europe Ltd
Belfast, Antrim, BT2 7BA
Diabetes Centre, Heartlands Hospital
Birmingham, B9 5SS
NHS Lothian
Edinburgh, EH16 4SA
Highland Diabetes Institute
Inverness, IV2 3JH
About this study
Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences with patients with Type I and Type II diabetes.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- OneTouch Reveal® Mobile APP, OneTouch Verio® Flex BGMS
- Keywords
- Diabetes Mellitus, A1c
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OneTouch Reveal® Mobile APPDevice
Diabetes management application for use on a mobile phone.
OneTouch Verio® Flex BGMSDevice
Blood Glucose Monitoring System (BGMS)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OneTouch Reveal® Mobile APP; Device: OneTouch Verio® Flex BGMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Weeks
Secondary outcomes (5)
A1c ≤ 7.0%
Measured: 12 and 24 weeks
Change in A1c from baseline
Measured: 12 and 24 weeks
Quantity and percentage of glucose results within personalized glycemic ranges set by HCP at baseline.
Measured: 12 and 24 weeks
Percentage of patients that performed SMBG tests as instructed by HCP.
Measured: 24 weeks
OneTouch Reveal Mobile APP interaction and usage via APP analytics over 24wks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeScan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bio-Kinetic Europe, Ltd.
- Responsible party
- Sponsor
- Investigators
- Mike Grady, Study director, LifeScan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429024
- Sponsor's protocol ID
- 3132245
- Status last verified
- Sep 2016
- First submitted
- 14 Apr 2015
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30291092
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences
- ClinicalTrials.gov ID
- NCT02429024
- Acronym / sponsor ID
- 3132245
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, A1c
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- LifeScanIndustry (pharma, biotech, devices)
- Collaborators
- Bio-Kinetic Europe, Ltd.
- Study start
- May 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: OneTouch Reveal® Mobile APP, Device: OneTouch Verio® Flex BGMSSubjects 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OneTouch Reveal® Mobile APPDiabetes management application for use on a mobile phone. | Device | Intervention |
| OneTouch Verio® Flex BGMSBlood Glucose Monitoring System (BGMS) | Device | Intervention |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Derived from this study: PubMed 30291092Grady 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Grady study director
LifeScan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OneTouch Reveal® Mobile APP and OneTouch Verio® Flex BGMS in people with Diabetes Mellitus, run by LifeScan at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.