Study Summary
This trial will explore how CGM and mHealth platforms can help people with diabetes better control their weight and improve eating and exercise habits.
Eligible Conditions
- Metabolic Syndrome
- Type 2 Diabetes
- Insulin Resistance
- Diabetes
- Weight Loss
- Abdominal Obesity
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
5 Primary · 0 Secondary · Reporting Duration: During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.
Year 6
App engagement
Change in weight
Change in weight in pounds
Glucose Metrics
Glucose Metrics via Continuous Glucose Measurement (CGM)
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
Signos digital health app and CGM
1 of 1
Experimental Treatment
20000 Total Participants · 1 Treatment Group
Primary Treatment: Signos digital health app and CGM · No Placebo Group · N/A
Signos digital health app and CGM
Device
Experimental Group · 1 Intervention: Continuous Glucose Monitor Device · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.
Who is running the clinical trial?
Signos IncLead Sponsor
1 Previous Clinical Trials
50,000 Total Patients Enrolled
1 Trials studying Metabolic Syndrome
50,000 Patients Enrolled for Metabolic Syndrome
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
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- 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.
- 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.
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- 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.
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- Stephanie Kim, M.D., MPH 2023. "Signos DM2 Empowerment Study (SIGNOS-CGM-EMPOWER-201-2022)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05874635.
Frequently Asked Questions
Are there any opportunities for individuals to become involved in this research endeavor?
"Clinicaltrials.gov lists this trial as actively seeking participants, with the first post date being dated back to May 11th 2023 and most recent update having taken place on May 16th of the same year." - Anonymous Online Contributor
Unverified Answer
How many participants are currently enrolled in this clinical trial?
"Affirmative. Clinicaltrials.gov reflects that this clinical trial is actively recruiting candidates since the initial post date of May 11th 2023, and its most current update on May 16th 2023. It requires approximately 20,000 patients to be recruited from one site." - Anonymous Online Contributor
Unverified Answer