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Eine Studie entspricht den Filterkriterien
Kartenansicht
Using Signos mHealth Platform in Adults for Weight Management (SWEET)
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06214221 (SWEET) ist eine interventionsstudie zur Untersuchung von Übergewicht und Adipositas, Metabolisches Syndrom, Gewichtsverlust und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 2. Januar 2024 und soll 380 Teilnehmer aufnehmen. Durchgeführt von Signos Inc ist der Abschluss für 30. April 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 8. Oktober 2024 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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.
Offizieller Titel
A Randomized Controlled Trial Evaluating the Safety and Effectiveness of the Intelligently-Driven Signos System for Personalized Weight Management in Overweight and Obese Adults
Erkrankungen
Übergewicht und AdipositasMetabolisches SyndromGewichtsverlustPublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Weitere Studien-IDs
- SWEET
- SIGNOS-CGM-SWEET-301-2023
NCT-Nummer
Studienbeginn (tatsächlich)
2024-01-02
Zuletzt aktualisiert
2024-10-08
Studienende (vorauss.)
2026-04-30
Geplante Rekrutierung
380
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Aktiv, nicht rekrutierend
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellSignos System For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness. | 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. |
Aktives VergleichspräparatStandard Lifestyle Education 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. | 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. |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
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 |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
22 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
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.
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.
Signos IncLindus Health, Inc.Verantwortliche Partei
Stephanie Kim, M.D., MPH, Hauptprüfer, Clinical Trial Investigator, Signos Inc
Keine Kontaktdaten vorhanden
5 Studienstandorte in 1 Ländern
Arizona
Helios Clinical Research (Phoenix), Phoenix, Arizona, 85028, United States
California
Diablo Clinical Research, Walnut Creek, California, 94598, United States
Florida
Segal Trials, North Miami, Florida, 33161, United States
Texas
Helios Clinical Research, Houston, Texas, 77008, United States
Washington
Seattle Clinical Research, Seattle, Washington, 98105, United States