Signos DM2 Empowerment Study (SIGNOS-CGM-EMPOWER-201-2022)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Use of Signos mHealth Platform in Participants With Non-Insulin Dependent Type 2 Diabetes: Weight and Blood Glucose

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874635
• Other study ID #: 201-2022
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2023
• Est. completion date: May 10, 2029

Study information

• Verified date: January 2024
• Source: Signos Inc
• Contact: Study Administration
• Phone: 6502634502
• Email: clinicaltrials[@]signos.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: May 10, 2029
• Est. primary completion date: May 10, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Obesity
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Glucose Metabolism Disorders
• Insulin Resistance
• Metabolic Glucose Disorders
• Metabolic Syndrome
• Obesity, Abdominal
• Weight Loss

Intervention

Device:
• Continuous Glucose Monitor Device
Continuous glucose monitoring automatically tracks blood glucose levels, also called blood sugar, throughout the day and night. You can see your glucose level anytime at a glance. You can also review how your glucose changes over a few hours or days to see trends. Seeing glucose levels in real time can help you make more informed decisions throughout the day about how to balance your food and physical activity.

Locations

Country	Name	City	State
United States	Signos	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Signos 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 — 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/n — 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 — 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 Me — 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 — 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 — 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, Elina — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Metrics via Continuous Glucose Measurement (CGM)	Glucose measured in mg/dl	During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.
Primary	Change in weight in pounds	Change in number of pounds	During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.
Primary	App engagement	Meals logged, Exercises logged, Activities completed	During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.