Diabetes Mellitus, Type 2ECLIPSENCT05354297
Evidence for Health Improvement in People With Diabetes Using One Touch & Partner Solutions
A study testing Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app, Fitbit plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app and Noom plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app in people with Diabetes Mellitus, Type 2, run by LifeScan at 1 site in United States.
Trial summary
ECLIPSE will evaluate the clinical and economic value of OneTouch Solutions in a real world study design. OneTouch Solutions describes a selection of devices and health and wellness solutions that people with diabetes (PWDs) can access online via OneTouch Solutions (Cecelia Health, Fitbit, Noom or Welldoc, each in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app, Fitbit plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app and Noom plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2022to 1 Sep 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self reports a diagnosis of type 2 diabetes
- HbA1c ≥7.5% but ≤12% at screening
- Currently instructed by a health care provider (HCP) to use a blood glucose meter to test blood sugar
- Has a compatible smartphone and willing to redownload apps if they change phones during the study
- Has a stable and consistent home and/or office internet connection
- Currently on at least 1 oral (by mouth) or injected anti-diabetic medication (for lowering your blood glucose) with or without insulin therapy (insulin injections or an insulin pump) at screening
Who cannot join
- Currently pregnant or planning to be pregnant in the next 12 months
- Body Mass Index < 27
- Currently using a CGM (Continuous glucose monitor) or have used a personal CGM in the past 3 months
- Currently using a OneTouch Verio Reflect meter
- For FitBit arm only: Currently uses related fitness applications (e.g., MyFitnessPal, JEFIT, Fitness Coach, Yoga-Go, etc.) or wearable device (e.g., Fitbit, Apple Watch, Garmin, Withings, etc.) in the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Evidation Health
San Mateo, California, 94402
Wei-Nchih Lee, MD, wlee@evidation.com
About this study
Official title: Evidence for Health Improvement in People With Diabetes Using One Touch & Partner Solutions (ECLIPSE)
ECLIPSE will evaluate the clinical and economic value of OneTouch Solutions in a real world study design. OneTouch Solutions describes a selection of devices and health and wellness solutions that people with diabetes (PWDs) can access online via OneTouch Solutions (Cecelia Health, Fitbit, Noom or Welldoc, each in combination with OneTouch Verio Reflect® blood glucose meter and the OneTouch Reveal® mobile app (or Welldoc app for the Welldoc arm)). ECLIPSE is a large parallel arm digital health study combining advanced blood glucose monitoring solutions with a choice of four different health and wellness applications or services. There are four unique study arms that will run in parallel over one year. The primary (A1c) endpoint for each study arm will be after 6 months and subjects will continue to use the interventions for a full year to generate data on sustained engagement with these products and services, and to collect healthcare utilization and health insurance claims information. Each study arm will differ to some degree in terms of patient baseline demographics (since subjects self-select their own app/intervention) and the experience per arm will be unique, and therefore each study arm will be analysed separately in terms of endpoints and outcomes.
Read the detailed description
ECLIPSE (Evidence for health improvement in people with diabetes using One Touch \& Partner Solutions) is a large parallel arm digital health study that will allow people with diabetes (PWDs) the freedom to choose the solution that is right for them, rather than forcibly randomize subjects to a specific study intervention. The intention of this real world study design is to mimic the choice PWDs will have when selecting a diabetes \& digital health solution from the OneTouch Solutions website.
A target of 800 people with type 2 diabetes (PwT2Ds) will be recruited and offered one of four interventions with the aim of following 200 PWDs per study arm. Subjects in all four study arms will use a bluetooth connected OneTouch Verio Reflect blood glucose meter (BGM) which features a dynamic color range indicator (DCRI) and blood sugar mentor (BSM) insights. Subjects in three of the four study arms will also sync their Reflect BGM to the OneTouch Reveal (OTR) mobile diabetes app to enable further insights (PWDs in the Welldoc study arm will not use the OTR app).
The 4 unique study arms will also offer PWDs one of the following Partner offerings;
- Cecelia Health, which offers guidance from certified Diabetes Care and Education Specialists
- Fitbit, which offers activity and wellbeing insight from use of the Fitbit Inspire 2 tracker, and Fitbit Premium subscription
- Noom, a psychology-based weight and wellness program
- Welldoc, which offers personalized health coaching on multiple conditions, namely prediabetes, diabetes, hypertension and heart failure
ECLIPSE will gather glycemic measures, medication adherence, a variety of patient reported outcomes and partner app usage and app engagement analytics over one year. Health economic data (HECON) from PWDs from the year of participation in ECLIPSE will be analysed from a purchased dataset and a comparison will be made to HECON data from the same PWDs for the year prior to taking part in the study. In addition, a matched control group of PwT2D from the same purchased dataset will be compared to the data from all four study arms.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app, Fitbit plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app, Noom plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app, Welldoc plus OneTouch Verio Reflect® BGM and Welldoc app
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile appDevice
Expert guidance via coaching
Fitbit plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile appDevice
Fitness and wellness guidance
Noom plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile appDevice
Behavioral weight loss program
Welldoc plus OneTouch Verio Reflect® BGM and Welldoc appDevice
Multi condition support
| Study group | Role | What they receive |
|---|---|---|
| Cecelia Health | Experimental | Access to live Cecelia health coach on the telephone for 1 year plus access to Cecelia health coach by text messaging (via the OneTouch Reveal mobile diabetes app). Subjects will be provided with the OneTouch Verio Reflect glucose meter and the OneTouch Reveal (OTR) diabetes app. Receives: Device: Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app |
| Fitbit | Experimental | Fitbit Inspire 2 wearable plus 1 year subscription to premium Fitbit application. Subjects will also be provided with the OneTouch Verio Reflect glucose meter and the OneTouch Reveal (OTR) mobile diabetes app. Receives: Device: Fitbit plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app |
| Noom | Experimental | Noom behavioural weight loss program subscription for 1 year. Subjects will also be provided with the OneTouch Verio Reflect glucose meter and the OneTouch Reveal (OTR) mobile diabetes app. Receives: Device: Noom plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app |
| Welldoc | Experimental | Multi-condition support program from Welldoc subscription for 1 year. Subjects will also be provided with the OneTouch Verio Reflect glucose meter. Receives: Device: Welldoc plus OneTouch Verio Reflect® BGM and Welldoc app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in A1c from screening to 3 and 6 months in each of the OneTouch Solutions programs
Measured: 3 and 6 months
Secondary outcomes (5)
Change in mean blood glucose derived from blood glucose testing throughout the study in each of the OneTouch Solutions programs
Measured: 3 and 6 months
Change from baseline in diabetes distress as assessed by the diabetes distress scale (DDS) after 3 and 6 months
Measured: 3 and 6 months
Change from baseline in well-being as assessed by the WHO-5 survey after 3 and 6 months
Measured: 3 and 6 months
Change from baseline in patient activation measures as assessed by PAM-13 survey after 3 and 6 months
Measured: 3 and 6 months
Change from baseline in medication adherence as assessed by a medication adherence survey after 3 and 6 months
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start26 Jul 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeScan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Evidation Health
- Responsible party
- Sponsor
- Investigators
- Wei-Nchih Lee, PhD, Principal investigator, Evidation Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354297
- Sponsor's protocol ID
- Pro00062350
- Acronym
- ECLIPSE
- Status last verified
- Jul 2022
- First submitted
- 18 Apr 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence for Health Improvement in People With Diabetes Using One Touch & Partner Solutions (ECLIPSE)
- ClinicalTrials.gov ID
- NCT05354297
- Acronym / sponsor ID
- ECLIPSE / Pro00062350
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- LifeScanIndustry (pharma, biotech, devices)
- Collaborators
- Evidation Health
- Study start
- 26 Jul 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 29 Apr 2022 (actual)
- 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.
ECLIPSE will evaluate the clinical and economic value of OneTouch Solutions in a real world study design. OneTouch Solutions describes a selection of devices and health and wellness solutions that people with diabetes (PWDs) can access online via OneTouch Solutions (Cecelia Health, Fitbit, Noom or Welldoc, each in combination with OneTouch Verio Reflect® blood glucose meter and the OneTouch Reveal® mobile app (or Welldoc app for the Welldoc arm)). ECLIPSE is a large parallel arm digital health study combining advanced blood glucose monitoring solutions with a choice of four different health and wellness applications or services. There are four unique study arms that will run in parallel over one year. The primary (A1c) endpoint for each study arm will be after 6 months and subjects will continue to use the interventions for a full year to generate data on sustained engagement with these products and services, and to collect healthcare utilization and health insurance claims information. Each study arm will differ to some degree in terms of patient baseline demographics (since subjects self-select their own app/intervention) and the experience per arm will be unique, and therefore each study arm will be analysed separately in terms of endpoints and outcomes.
Detailed description
ECLIPSE (Evidence for health improvement in people with diabetes using One Touch \& Partner Solutions) is a large parallel arm digital health study that will allow people with diabetes (PWDs) the freedom to choose the solution that is right for them, rather than forcibly randomize subjects to a specific study intervention. The intention of this real world study design is to mimic the choice PWDs will have when selecting a diabetes \& digital health solution from the OneTouch Solutions website.
A target of 800 people with type 2 diabetes (PwT2Ds) will be recruited and offered one of four interventions with the aim of following 200 PWDs per study arm. Subjects in all four study arms will use a bluetooth connected OneTouch Verio Reflect blood glucose meter (BGM) which features a dynamic color range indicator (DCRI) and blood sugar mentor (BSM) insights. Subjects in three of the four study arms will also sync their Reflect BGM to the OneTouch Reveal (OTR) mobile diabetes app to enable further insights (PWDs in the Welldoc study arm will not use the OTR app).
The 4 unique study arms will also offer PWDs one of the following Partner offerings;
- Cecelia Health, which offers guidance from certified Diabetes Care and Education Specialists
- Fitbit, which offers activity and wellbeing insight from use of the Fitbit Inspire 2 tracker, and Fitbit Premium subscription
- Noom, a psychology-based weight and wellness program
- Welldoc, which offers personalized health coaching on multiple conditions, namely prediabetes, diabetes, hypertension and heart failure
ECLIPSE will gather glycemic measures, medication adherence, a variety of patient reported outcomes and partner app usage and app engagement analytics over one year. Health economic data (HECON) from PWDs from the year of participation in ECLIPSE will be analysed from a purchased dataset and a comparison will be made to HECON data from the same PWDs for the year prior to taking part in the study. In addition, a matched control group of PwT2D from the same purchased dataset will be compared to the data from all four study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cecelia Health | Experimental | Device: Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile appAccess to live Cecelia health coach on the telephone for 1 year plus access to Cecelia health coach by text messaging (via the OneTouch Reveal mobile diabetes app). Subjects will be provided with the OneTouch Verio Reflect glucose meter and the OneTouch Reveal (OTR) diabetes app. |
| Fitbit | Experimental | Device: Fitbit plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile appFitbit Inspire 2 wearable plus 1 year subscription to premium Fitbit application. Subjects will also be provided with the OneTouch Verio Reflect glucose meter and the OneTouch Reveal (OTR) mobile diabetes app. |
| Noom | Experimental | Device: Noom plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile appNoom behavioural weight loss program subscription for 1 year. Subjects will also be provided with the OneTouch Verio Reflect glucose meter and the OneTouch Reveal (OTR) mobile diabetes app. |
| Welldoc | Experimental | Device: Welldoc plus OneTouch Verio Reflect® BGM and Welldoc appMulti-condition support program from Welldoc subscription for 1 year. Subjects will also be provided with the OneTouch Verio Reflect glucose meter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self reports a diagnosis of type 2 diabetes
- HbA1c ≥7.5% but ≤12% at screening
- Currently instructed by a health care provider (HCP) to use a blood glucose meter to test blood sugar
- Has a compatible smartphone and willing to redownload apps if they change phones during the study
- Has a stable and consistent home and/or office internet connection
Key exclusion criteria (5 listed)
- Currently pregnant or planning to be pregnant in the next 12 months
- Body Mass Index < 27
- Currently using a CGM (Continuous glucose monitor) or have used a personal CGM in the past 3 months
- Currently using a OneTouch Verio Reflect meter
- For FitBit arm only: Currently uses related fitness applications (e.g., MyFitnessPal, JEFIT, Fitness Coach, Yoga-Go, etc.) or wearable device (e.g., Fitbit, Apple Watch, Garmin, Withings, etc.) in the past 6 months
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 |
|---|---|---|
| Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile appExpert guidance via coaching | Device | Cecelia Health |
| Fitbit plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile appFitness and wellness guidance | Device | Fitbit |
| Noom plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile appBehavioral weight loss program | Device | Noom |
| Welldoc plus OneTouch Verio Reflect® BGM and Welldoc appMulti condition support | Device | Welldoc |
Primary outcome
Changes in A1c from screening to 3 and 6 months in each of the OneTouch Solutions programs
Time frame: 3 and 6 months
5 secondary outcomes
Change in mean blood glucose derived from blood glucose testing throughout the study in each of the OneTouch Solutions programs
Time frame: 3 and 6 months
Change from baseline in diabetes distress as assessed by the diabetes distress scale (DDS) after 3 and 6 months
Time frame: 3 and 6 months
Change from baseline in well-being as assessed by the WHO-5 survey after 3 and 6 months
Time frame: 3 and 6 months
Change from baseline in patient activation measures as assessed by PAM-13 survey after 3 and 6 months
Time frame: 3 and 6 months
Change from baseline in medication adherence as assessed by a medication adherence survey after 3 and 6 months
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Wei-Nchih Lee, PhD principal investigator
Evidation Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app, Fitbit plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app and Noom plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app in people with Diabetes Mellitus, Type 2, run by LifeScan at 1 site in United States.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mike Grady, PhD (07775704444, mgrady@lifescan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in A1c from screening to 3 and 6 months in each of the OneTouch Solutions programs (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2022.