Overweight and ObesitySWEETNCT06214221

Using Signos mHealth Platform in Adults for Weight Management

A study testing Signos System and Standard Lifestyle Education in people with Overweight and Obesity and Metabolic Syndrome, run by Signos Inc at 5 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for: Overweight and Obesity, Metabolic Syndrome, Weight Loss
What is being tested?: Signos System and Standard Lifestyle Education
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 380 participants
Where: 5 sitesUnited States
Study dates: 2 Jan 2024to 30 Apr 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 9Show fewer

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Helios Clinical Research
Houston, Texas, 77008
Segal Trials
North Miami, Florida, 33161
Helios Clinical Research (Phoenix)
Phoenix, Arizona, 85028
Seattle Clinical Research
Seattle, Washington, 98105
Diablo Clinical Research
Walnut Creek, California, 94598

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions: Overweight and Obesity, Metabolic Syndrome, Weight Loss
Being tested: Signos System, Standard Lifestyle Education
Medical subject headings: Overweight, Obesity, Metabolic Syndrome, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06214221
Study group	Role	What they receive
Signos System	Experimental	For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness. Receives: Device: Signos System
Standard Lifestyle Education	Active comparator	The "Active Comparator: Standard Lifestyle Education" arm in the clinical trial refers to a control group that receives conventional lifestyle modification advice instead of the experimental Signos System. Receives: Other: Standard Lifestyle Education

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 Months
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.
Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 202430 Apr 2026

First posted19 Jan 2024
Study start2 Jan 2024
Primary completion31 Dec 2024 (estimated)
Study completion30 Apr 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Overweight and ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: In an open-label randomization model, participants and researchers both know the treatment each participant is receiving. This model involves randomly assigning participants to different treatment groups, ensuring unbiased distribution across interventions, but without concealing the nature of the treatment from either the participants or the study team.
Masking: None (open label)
Enrolment: 380 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06214221
Sponsor's protocol ID: SIGNOS-CGM-SWEET-301-2023
Acronym: SWEET
Status last verified: Oct 2024
First submitted: 9 Jan 2024
Last updated: 8 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 30040822
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.
PubMed 23467903
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.
PubMed 26590418
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.
PubMed 11576521
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.
PubMed 34323335
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.
PubMed 27819345
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.
PubMed 34582545
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.
PubMed 30066574
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.
PubMed 33676599
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.
PubMed 30236381
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.
PubMed 31346341
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.
PubMed 22238401
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.
PubMed 31489455
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.
PubMed 31217353

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06214221
Acronym / sponsor ID: SWEET / SIGNOS-CGM-SWEET-301-2023
Conditions: Overweight and Obesity, Metabolic Syndrome, Weight Loss
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 380 participants (actual)
Lead sponsor: Signos IncIndustry (pharma, biotech, devices)
Collaborators: Lindus Health, Inc.
Study start: 2 Jan 2024 (actual)
Primary completion: 31 Dec 2024 (estimated)
Study completion: 30 Apr 2026 (estimated)
First posted: 19 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: In an open-label randomization model, participants and researchers both know the treatment each participant is receiving. This model involves randomly assigning participants to different treatment groups, ensuring unbiased distribution across interventions, but without concealing the nature of the treatment from either the participants or the study team.

Arm	Type	Receives
Signos System	Experimental	Device: Signos SystemFor all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness.
Standard Lifestyle Education	Active comparator	Other: Standard Lifestyle EducationThe "Active Comparator: Standard Lifestyle Education" arm in the clinical trial refers to a control group that receives conventional lifestyle modification advice instead of the experimental Signos System.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Signos SystemThe 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.	Device	Signos System
Standard Lifestyle EducationIn the "Standard Lifestyle Education" arm, participants receive conventional advice on diet and exercise, focusing on general healthy lifestyle habits to manage weight.	Other	Standard Lifestyle Education

Primary outcome

Responder Rate
Time frame: 6 Months
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.
Average Total Body Weight Loss (TBWL%)
Time frame: 6 Months
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.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Background: PubMed 30040822Hall 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.
Background: PubMed 23467903Adams 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.
Background: PubMed 26590418Zeevi 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.
Background: PubMed 11576521Baron 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.
Background: PubMed 34323335Brown 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.
Background: PubMed 27819345Chin 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.
Background: PubMed 34582545Ebbeling 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.
Background: PubMed 30066574Ehrhardt 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.
Background: PubMed 33676599The 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.
Background: PubMed 30236381Galderisi 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.
Background: PubMed 31346341Gonzalez-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.
Background: PubMed 22238401Guyenet 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephanie Kim, MD study chair

Signos Inc

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Signos System and Standard Lifestyle Education in people with Overweight and Obesity and Metabolic Syndrome, run by Signos Inc at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder Rate (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06214221, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.