Using the Lumen Device for Prediabetes Prevention
Using the Lumen Device for Prediabetes Prevention
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..
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.
Inclusion Criteria:

 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

 Exclusion Criteria:

 Medications:

 1. Insulin and medications for glycemic control

 2. Antipsychotics

 3. Diuretics

 4. Anti-retrovirals

 5. Corticosteroids

 6. Oncologic treatment

 7. Thyroid hormones (if endocrinological control is good, can be included).

 Conditions:

 1. Previous diagnosis of diabetes

 2. G6PD deficiency

 3. Renal disease

 4. Hepatic disease

 5. Pregnancy

 6. Hematological (anemia)

 7. Suffered heart attack, stroke, or transient ischemic attack in the past 6 months

 8. Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood
 pressure > 105 mm Hg)

 9. Treatment of cancer (excluding surgery alone) within the past 2 years (excluding skin
 cancer)

 10. Reported chest pain, shortness of breath with minimal activity or at rest, or
 unexplained dizziness or fainting with physical activity

 11. Chronic lung disease (chronic obstructive pulmonary disease or asthma requiring oxygen
 therapy)

 Personal requirements:

 1. Inability to read and understand English

 2. Inability to use a smartphone

 3. Any issues arise with using the Lumen device and application

 4. Aerobic exercise > 3 times per week

 5. Active participation in diet counseling or active weight loss (> 3 kg in the past one
 month)

 6. Change of diet or physical activity in the last 3 months