Using Signos mHealth Platform in Adults for Weight Management

Metabolic Syndrome Clinical Trial

— SWEET  

Official title:

A Randomized Controlled Trial Evaluating the Safety and Effectiveness of the Intelligently-Driven Signos System for Personalized Weight Management in Overweight and Obese Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06214221
• Other study ID #: SIGNOS-CGM-SWEET-301-2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Signos Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Metabolic syndrome and resulting downstream health effects remains a growing health concern. In published trials, the use of continuous glucose monitoring (CGM) assists behavioral changes efforts, leading to improved adherence and results from diet and exercise changes in individuals with obesity. Mobile health (mHealth) platforms provide satisfactory, easy-to-use tools that help participants in the pursuit of weight change goals. The investigators hypothesize that the use of CGM data and targeted coaching and nutrition education will assist with weight optimization goals in the general (non-diabetic) population using the Signos mHealth platform, with associated health benefits.

Description:

The scope of this study is to enroll participants into a study that utilizes a continuous glucose monitor (CGM) and mobile health application [Signos] to optimize general wellness and body weight and composition. The Signos users will be compared against a control arm.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 380
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

To join our study, participant need to:

• Be at least 22 years old.

• Be overweight or obese, which we define as having a Body Mass Index (BMI) between 25 and 40.

• HbA1c test result should be below 6.5% at the start of the study.

• Have and know how to use a smartphone that's compatible with the Signos app.

• Be able to understand, speak, and read English well enough to participate fully in the study.

Exclusion Criteria:

Participant can't join our study if participant has:

• Have Type 1 or Type 2 diabetes.

• Are already using a device to monitor glucose level.

• Have severe allergies to the sticky part of glucose monitors.

• Suffer from an eating disorder like anorexia or bulimia.

• Are currently taking certain medications for diabetes or weight loss.

• Have had or are planning to have weight loss surgery.

• Have major health issues like severe kidney disease, untreated thyroid problems, or skin conditions where the glucose monitor would be placed.

• Have been part of another clinical trial recently.

Related Conditions & MeSH terms

• Body Weight
• Metabolic Syndrome
• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Device:
• Signos System
The intervention involves the use of the Signos System, a combination of a proprietary software application with a continuous glucose monitor (CGM), to manage weight in overweight and obese adults.

Other:
• Standard Lifestyle Education
In the "Standard Lifestyle Education" arm, participants receive conventional advice on diet and exercise, focusing on general healthy lifestyle habits to manage weight.

Locations

Country	Name	City	State
United States	Helios Clinical Research	Houston	Texas
United States	Segal Trials	North Miami	Florida
United States	Helios Clinical Research (Phoenix)	Phoenix	Arizona
United States	Seattle Clinical Research	Seattle	Washington
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
Signos Inc	Lindus Health, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (14)

Adams OP. The impact of brief high-intensity exercise on blood glucose levels. Diabetes Metab Syndr Obes. 2013;6:113-22. doi: 10.2147/DMSO.S29222. Epub 2013 Feb 27. — View Citation

Baron AD. Impaired glucose tolerance as a disease. Am J Cardiol. 2001 Sep 20;88(6A):16H-9H. doi: 10.1016/s0002-9149(01)01832-x. — View Citation

Brown A, McArdle P, Taplin J, Unwin D, Unwin J, Deakin T, Wheatley S, Murdoch C, Malhotra A, Mellor D. Dietary strategies for remission of type 2 diabetes: A narrative review. J Hum Nutr Diet. 2022 Feb;35(1):165-178. doi: 10.1111/jhn.12938. Epub 2021 Sep 1. — View Citation

Chin SO, Keum C, Woo J, Park J, Choi HJ, Woo JT, Rhee SY. Successful weight reduction and maintenance by using a smartphone application in those with overweight and obesity. Sci Rep. 2016 Nov 7;6:34563. doi: 10.1038/srep34563. — View Citation

Ebbeling CB, Knapp A, Johnson A, Wong JMW, Greco KF, Ma C, Mora S, Ludwig DS. Effects of a low-carbohydrate diet on insulin-resistant dyslipoproteinemia-a randomized controlled feeding trial. Am J Clin Nutr. 2022 Jan 11;115(1):154-162. doi: 10.1093/ajcn/nqab287. Erratum In: Am J Clin Nutr. 2022 Jan 11;115(1):310. — View Citation

Ehrhardt N, Al Zaghal E. Behavior Modification in Prediabetes and Diabetes: Potential Use of Real-Time Continuous Glucose Monitoring. J Diabetes Sci Technol. 2019 Mar;13(2):271-275. doi: 10.1177/1932296818790994. Epub 2018 Aug 1. — View Citation

Galderisi A, Giannini C, Weiss R, Kim G, Shabanova V, Santoro N, Pierpont B, Savoye M, Caprio S. Trajectories of changes in glucose tolerance in a multiethnic cohort of obese youths: an observational prospective analysis. Lancet Child Adolesc Health. 2018 Oct;2(10):726-735. doi: 10.1016/S2352-4642(18)30235-9. Epub 2018 Aug 24. — View Citation

Gonzalez-Rodriguez M, Pazos-Couselo M, Garcia-Lopez JM, Rodriguez-Segade S, Rodriguez-Garcia J, Tunez-Bastida C, Gude F. Postprandial glycemic response in a non-diabetic adult population: the effect of nutrients is different between men and women. Nutr Metab (Lond). 2019 Jul 17;16:46. doi: 10.1186/s12986-019-0368-1. eCollection 2019. — View Citation

Guyenet SJ, Schwartz MW. Clinical review: Regulation of food intake, energy balance, and body fat mass: implications for the pathogenesis and treatment of obesity. J Clin Endocrinol Metab. 2012 Mar;97(3):745-55. doi: 10.1210/jc.2011-2525. Epub 2012 Jan 11. — View Citation

Hall H, Perelman D, Breschi A, Limcaoco P, Kellogg R, McLaughlin T, Snyder M. Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol. 2018 Jul 24;16(7):e2005143. doi: 10.1371/journal.pbio.2005143. eCollection 2018 Jul. — View Citation

Hamley S, Kloosterman D, Duthie T, Dalla Man C, Visentin R, Mason SA, Ang T, Selathurai A, Kaur G, Morales-Scholz MG, Howlett KF, Kowalski GM, Shaw CS, Bruce CR. Mechanisms of hyperinsulinaemia in apparently healthy non-obese young adults: role of insulin secretion, clearance and action and associations with plasma amino acids. Diabetologia. 2019 Dec;62(12):2310-2324. doi: 10.1007/s00125-019-04990-y. Epub 2019 Sep 6. — View Citation

Hyde PN, Sapper TN, Crabtree CD, LaFountain RA, Bowling ML, Buga A, Fell B, McSwiney FT, Dickerson RM, Miller VJ, Scandling D, Simonetti OP, Phinney SD, Kraemer WJ, King SA, Krauss RM, Volek JS. Dietary carbohydrate restriction improves metabolic syndrome independent of weight loss. JCI Insight. 2019 Jun 20;4(12):e128308. doi: 10.1172/jci.insight.128308. eCollection 2019 Jun 20. — View Citation

The Lancet Diabetes Endocrinology. Metabolic health: a priority for the post-pandemic era. Lancet Diabetes Endocrinol. 2021 Apr;9(4):189. doi: 10.1016/S2213-8587(21)00058-9. Epub 2021 Mar 4. No abstract available. — View Citation

Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder Rate	Investigators will measure how many participants successfully reached their weight management goals by the end of 6 months. This 'Responder Rate' tells us the percentage of people in our study who effectively managed their weight using the methods we provided, whether it's through the Signos System or standard lifestyle education.	6 Months
Primary	Average Total Body Weight Loss (TBWL%)	Investigators will measure how much weight, on average, participants have lost after 6 months in the study. This will be calculated as a percentage of their initial weight. This measure helps us understand the effectiveness of the Signos System in helping participants reduce their body weight over a 6-month period.	6 Months