Using the Lumen Device for Prediabetes Prevention
1 other identifier
interventional
40
1 country
1
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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2020
CompletedFirst Posted
Study publicly available on registry
September 18, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedSeptember 18, 2020
September 1, 2020
1 year
September 16, 2020
September 16, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Weight change
% weight change
from baseline to 12 weeks
Fat percentage
% change in fat percentage
from baseline to 12 weeks
Secondary Outcomes (3)
Blood tests changes - glycemic control
from baseline to 12 weeks
Blood tests changes- lipid panel change
from baseline to 12 weeks
Blood tests changes - glycemic control
from baseline to 12 weeks
Study Arms (1)
Lumen device usage and diet guidelines
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Medications:
- Insulin and medications for glycemic control
- Antipsychotics
- Diuretics
- Anti-retrovirals
- Corticosteroids
- 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)
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tel-Aviv Sourasky Medical Centerlead
- Metaflow Ltd.collaborator
Study Sites (1)
Institute of Endocrinology, Metabolism and Hypertension
Tel Aviv, 64239, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2020
First Posted
September 18, 2020
Study Start
October 1, 2020
Primary Completion
October 1, 2021
Study Completion
October 1, 2021
Last Updated
September 18, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share