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..

Study Overview

• Status: Unknown
• Conditions: PreDiabetes; Overweight and Obesity
• Intervention / Treatment: Device: Lumen

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roy Eldor, MD; PhD; Phone Number: +972-527360680; Email: roye@tlvmc.gov.il
• Study Contact Backup: Name: Assaf Buch, PhD; Phone Number: +972-549931033; Email: asafbu@tlvmc.gov.il

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Institute of Endocrinology, metabolism and hypertension

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Lumen device usage and diet guidelines

Device: Lumen; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change	% weight change	from baseline to 12 weeks
Fat percentage	% change in fat percentage	from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood tests changes - glycemic control	Fasting glucose (mg/dl)	from baseline to 12 weeks
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	from baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Metaflow Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (ACTUAL): September 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Hyperglycemia; Prediabetic State; Glucose Intolerance; Overweight
• Other Study ID Numbers: 0523-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No