PreDiabetesNCT04555421
Using the Lumen Device for Prediabetes Prevention
A study testing Lumen in people with PreDiabetes and Overweight and Obesity, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
To examine the effect of using Lumen on metabolic parameters and anthropometric variables. This will be done from baseline to the end of a 12 weeks intervention in adults with prediabetes.. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- PreDiabetes, Overweight and Obesity
- What is being tested?
- Lumen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2020to Oct 2021
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥ 27 to ≤ 40 HbA1c ≥ 5.7% to ≤6.4% Fasting glucose ≥ 100 mg/dl to ≤ 125 mg/dl Not treated with diabetes-related medications
Who cannot join
- Medications:
- Insulin and medications for glycemic control
- Antipsychotics
- Diuretics
- Anti-retrovirals
- Corticosteroids
Show all 27Show fewer
- Oncologic treatment
- Thyroid hormones (if endocrinological control is good, can be included).
- Conditions:
- Previous diagnosis of diabetes
- G6PD deficiency
- Renal disease
- Hepatic disease
- Pregnancy
- Hematological (anemia)
- Suffered heart attack, stroke, or transient ischemic attack in the past 6 months
- Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 105 mm Hg)
- Treatment of cancer (excluding surgery alone) within the past 2 years (excluding skin cancer)
- Reported chest pain, shortness of breath with minimal activity or at rest, or unexplained dizziness or fainting with physical activity
- Chronic lung disease (chronic obstructive pulmonary disease or asthma requiring oxygen therapy)
- Personal requirements:
- Inability to read and understand English
- Inability to use a smartphone
- Any issues arise with using the Lumen device and application
- Aerobic exercise > 3 times per week
- Active participation in diet counseling or active weight loss (> 3 kg in the past one month)
- Change of diet or physical activity in the last 3 months
Trial locations and contacts
1 site in 1 country.
Israel1 site
Institute of Endocrinology, Metabolism and Hypertension
Tel Aviv, 64239
About this study
To examine the effect of using Lumen on metabolic parameters and anthropometric variables. This will be done from baseline to the end of a 12 weeks intervention in adults with prediabetes..
Read the detailed description
A single arm intervention evaluation for 12 weeks (pre-post analysis) was designed for the study. After initial screening of the subjects, they will be familiarized with Lumen and will learn on how to take a measure. After 2 days of using Lumen device at home for acquaintance and calibration, subjects will arrive to the clinic and several baseline measurements will be taken, including blood samples and anthropometric variables. Then, subjects will use Lumen at home and will take a Lumen measurement each day for a period of 12 weeks. Subjects will take a Lumen measurement each morning at fasted state and will get a nutritional plan according to their result. In addition, subjects will be guided to log in the last time they consumed a meal (how long they fasted for), the duration of their sleep, and if they managed to follow the previous day recommendations. Moreover, the Lumen application will encourage the subjects to take more measurement throughout the day, in particular in response to food intake as well as before and after workouts. Lumen coach will remotely support the subjects via Lumen's mobile phone application and will provide clarifications and guidelines if needed based on the Lumen metric. Finally, subjects will return to the clinic for their final assessment which would include taking blood samples and anthropometric variables again.
The study will include 40 subjects the most with a minimal target of 30 subjects. The number of subjects was determined based on power analysis made according to a study evaluating HbA1c levels in prediabetic subjects who received low-carb diet for 12 weeks.
- Conditions
- PreDiabetes, Overweight and Obesity
- Being tested
- Lumen
- Medical subject headings
- Prediabetic State, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumenDevice
Subjects will use the Lumen device and mobile phone application, which will guide their diet, sleep, and routines according to their Lumen measurements. In addition, a Lumen coach will be assigned to the subjects, and they will have a 30 minutes video call with the coach during the familiarization stage, in order to acquaint them with Lumen and explain them about the application and the nutritional guidance.
| Study group | Role | What they receive |
|---|---|---|
| Lumen device usage and diet guidelines | Experimental | Not described Receives: Device: Lumen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
% weight change
Measured: from baseline to 12 weeks
Fat percentage
% change in fat percentage
Measured: from baseline to 12 weeks
Secondary outcomes (3)
Blood tests changes - glycemic control
HbA1C (%)
Measured: from baseline to 12 weeks
Blood tests changes- lipid panel change
Triglycerides, HDL and LDL cholesterol, total cholesterol) - change in mg/dl
Measured: from baseline to 12 weeks
Blood tests changes - glycemic control
Fasting glucose (mg/dl)
Measured: from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Metaflow Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555421
- Sponsor's protocol ID
- 0523-20
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Lumen Device for Prediabetes Prevention
- ClinicalTrials.gov ID
- NCT04555421
- Acronym / sponsor ID
- 0523-20
- Conditions
- PreDiabetes, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Metaflow Ltd.
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 18 Sep 2020 (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.
To examine the effect of using Lumen on metabolic parameters and anthropometric variables. This will be done from baseline to the end of a 12 weeks intervention in adults with prediabetes..
Detailed description
A single arm intervention evaluation for 12 weeks (pre-post analysis) was designed for the study. After initial screening of the subjects, they will be familiarized with Lumen and will learn on how to take a measure. After 2 days of using Lumen device at home for acquaintance and calibration, subjects will arrive to the clinic and several baseline measurements will be taken, including blood samples and anthropometric variables. Then, subjects will use Lumen at home and will take a Lumen measurement each day for a period of 12 weeks. Subjects will take a Lumen measurement each morning at fasted state and will get a nutritional plan according to their result. In addition, subjects will be guided to log in the last time they consumed a meal (how long they fasted for), the duration of their sleep, and if they managed to follow the previous day recommendations. Moreover, the Lumen application will encourage the subjects to take more measurement throughout the day, in particular in response to food intake as well as before and after workouts. Lumen coach will remotely support the subjects via Lumen's mobile phone application and will provide clarifications and guidelines if needed based on the Lumen metric. Finally, subjects will return to the clinic for their final assessment which would include taking blood samples and anthropometric variables again.
The study will include 40 subjects the most with a minimal target of 30 subjects. The number of subjects was determined based on power analysis made according to a study evaluating HbA1c levels in prediabetic subjects who received low-carb diet for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumen device usage and diet guidelines | Experimental | Device: Lumen |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI ≥ 27 to ≤ 40 HbA1c ≥ 5.7% to ≤6.4% Fasting glucose ≥ 100 mg/dl to ≤ 125 mg/dl Not treated with diabetes-related medications
Key exclusion criteria (27 listed)
- Insulin and medications for glycemic control
- Antipsychotics
- Diuretics
- Anti-retrovirals
- Corticosteroids
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 |
|---|---|---|
| LumenSubjects will use the Lumen device and mobile phone application, which will guide their diet, sleep, and routines according to their Lumen measurements. In addition, a Lumen coach will be assigned to the subjects, and they will have a 30 minutes video call with the coach during the familiarization stage, in order to acquaint them with Lumen and explain them about the application and the nutritional guidance. | Device | Lumen device usage and diet guidelines |
Primary outcome
Weight change
Time frame: from baseline to 12 weeks
% weight change
Fat percentage
Time frame: from baseline to 12 weeks
% change in fat percentage
3 secondary outcomes
Blood tests changes - glycemic control
Time frame: from baseline to 12 weeks
Blood tests changes- lipid panel change
Time frame: from baseline to 12 weeks
Blood tests changes - glycemic control
Time frame: from baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumen in people with PreDiabetes and Overweight and Obesity, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 inclusion and 27 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 18 Sep 2020. 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 Israel. 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 Roy Eldor, MD; PhD (+972-527360680, roye@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: from baseline to 12 weeks). The study lists 2 primary outcomes in all. 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 18 Sep 2020; AzTrials last refreshed its copy on 2 Nov 2026.