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| Name | Class |
|---|---|
| Metaflow Ltd. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumen device usage and diet guidelines | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumen | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change | % weight change | from baseline to 12 weeks |
| Fat percentage | % change in fat percentage | from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood tests changes - glycemic control | HbA1C (%) | from baseline to 12 weeks |
| Blood tests changes- lipid panel change | Triglycerides, HDL and LDL cholesterol, total cholesterol) - change in mg/dl |
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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:
Conditions:
Personal requirements:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roy Eldor, MD; PhD | Contact | +972-527360680 | roye@tlvmc.gov.il | |
| Assaf Buch, PhD | Contact | +972-549931033 | asafbu@tlvmc.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Endocrinology, Metabolism and Hypertension | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| from baseline to 12 weeks |
| Blood tests changes - glycemic control | Fasting glucose (mg/dl) | from baseline to 12 weeks |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |