Clinical trial NCT05874635: Signos DM2 Empowerment Study (SIGNOS-CGM-EMPOWER-201-2022)
Official title: Use of Signos mHealth Platform in Participants With Non-Insulin Dependent Type 2 Diabetes: Weight and Blood Glucose
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Weight Loss
Metabolic Syndrome
Diabetes Mellitus, Type 2
Central Obesity
Insulin Resistance
Glucose Intolerance
Metabolic Glucose Disorders
Keywords: health and wellness
excess adiposity
Lead sponsor: Signos Inc
Sponsor class: INDUSTRY
First posted: 2023-05-25
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label single-arm study
Primary purpose: TREATMENT

Brief summary: The use of continuous glucose monitoring (CGM) in earlier data has inspired behavioral changes leading to improved adherence to an exercise plan in individuals and eating habits in people with diabetes. Mobile health (mHealth) platforms provide satisfactory, easy-to-use tools to help participants in the pursuit of weight change goals. We hypothesize that the use of CGM data and the Signos mHealth platform will assist with weight control in a population of people with type 2 diabetes mellitus who are not using insulin.

Detailed description: The scope of this study is to enroll existing and new Signos non-insulin dependent type 2 diabetes mellitus users in a volunteer study that utilizes a continuous glucose monitor (CGM) and mobile health application \[Signos\] to optimize general wellness and body weight and composition. This is a no more than minimal risk study.

Eligibility criteria: Inclusion Criteria:

* Medical diagnosis of Type 2 Diabetes; determined by review of subject-provided most recent Hg A1c.
* Subject is under current care of a primary care provider or specialist
* Clearance by medical provider to participate in diet, physical activity, and lifestyle changes
* 18 years and above
* Own a smartphone and be willing to install the Signos App to personally receive text messages or have access to a web-based survey to self-report their weight.
* Willingness to complete quality of life questionnaires or other in-app surveys.
* Willingness to use CGM device
* Able to speak and read English
* Be a Signos mHealth (mobile/web-based) user

Exclusion Criteria:

* Medical diagnosis of Type 1 Diabetes
* Type 2 Diabetes currently using insulin or most recent A1c ≥10%
* Severe hypoglycemia \<54 mg/dl resulting in seizure or unconsciousness, or requiring assistance/EMS/hospitalization - within 3 months prior to enrollment
* Current medical diagnosis of an eating disorder (such as anorexia nervosa or bulimia)
* Medical conditions (e.g., such as seizure disorder) requiring a specific medical diet.
* Inborn error of metabolism such as phenylketonuria (PKU), glycogen storage disease, fructose intolerance, Maple Sugar Urine Disease (MSUD).
* History of 10 or more soft tissue skin infections (such as cellulitis or abscesses)
* Intolerable skin reaction from adhesive
* Currently taking any of the following medications: Clozapine, Hydroxyurea, or any form of insulin.

Primary outcomes:
measure: Glucose Metrics via Continuous Glucose Measurement (CGM)
timeFrame: During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.
measure: Change in weight in pounds
timeFrame: During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.
measure: App engagement
timeFrame: During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Signos
state: California
Study officials:
affiliation: Signos Inc
name: Stephanie Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.