Clinical trial NCT04555421: Using the Lumen Device for Prediabetes Prevention
Official title: Using the Lumen Device for Prediabetes Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PreDiabetes
Overweight and Obesity
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Metaflow Ltd.
First posted: 2020-09-18
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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..

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight change
timeFrame: from baseline to 12 weeks
measure: Fat percentage
timeFrame: from baseline to 12 weeks
Secondary outcomes:
measure: Blood tests changes - glycemic control
timeFrame: from baseline to 12 weeks
measure: Blood tests changes- lipid panel change
timeFrame: from baseline to 12 weeks
measure: Blood tests changes - glycemic control
timeFrame: from baseline to 12 weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Institute of Endocrinology, Metabolism and Hypertension
Study officials:
References: