Using the Lumen Device for Prediabetes Prevention

Status Not yet recruiting

Clinical Trial 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..

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04555421
Study type	Interventional
Source	Tel-Aviv Sourasky Medical Center
Contact	Roy Eldor, MD; PhD
Phone	+972-527360680
Email	roye@tlvmc.gov.il
Status	Not yet recruiting
Phase	N/A
Start date	October 2020
Completion date	October 2021

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT03994419` - PErioperAtive CHildhood ObesitY
Recruiting	`NCT05354245` - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)	N/A
Completed	`NCT03602001` - Attentive Eating for Weight Loss	N/A
Recruiting	`NCT06269159` - The Power of 24-hour: Co-designing Intervention Components
Completed	`NCT03377244` - Healthy Body Healthy Souls in the Marshallese Population	N/A
Completed	`NCT02996864` - Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II	N/A
Terminated	`NCT03914066` - A Group-based Treatment of Overweight and Obesity in Primary Care	N/A
Completed	`NCT04647149` - Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity	N/A
Completed	`NCT03685656` - Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers	N/A
Completed	`NCT05051579` - A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities	Phase 2
Completed	`NCT04611477` - Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals	N/A
Active, not recruiting	`NCT05330247` - Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study	N/A
Completed	`NCT03599115` - Effects of Inhibitory Control Training in Eating Behaviors	N/A
Recruiting	`NCT05938894` - Train Your Brain - Executive Function	N/A
Recruiting	`NCT06094231` - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study	N/A
Recruiting	`NCT05987306` - A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss	N/A
Completed	`NCT03792685` - Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention	N/A
Completed	`NCT05055362` - Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study	N/A
Completed	`NCT04520256` - Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy	Phase 2/Phase 3
Completed	`NCT04979234` - A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome	N/A