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

Launched by SIGNOS INC · May 16, 2023

Keywords

ClinConnect Summary

The Signos DM2 Empowerment Study is looking at how continuous glucose monitoring (CGM) and a mobile health app can help people with type 2 diabetes manage their weight and improve their overall health. The study aims to see if tracking glucose levels can lead to better eating habits and more adherence to exercise plans for individuals not using insulin. This research is currently recruiting participants aged 18 and older who have a medical diagnosis of type 2 diabetes and are under the care of a healthcare provider.

To participate, you’ll need to own a smartphone and be comfortable using the Signos app to track your weight and respond to surveys. Participants will use a CGM device to monitor their glucose levels and will have the opportunity to share their experiences through questionnaires. It's important to note that individuals with type 1 diabetes, those currently on insulin, or those with certain medical conditions are not eligible for this study. If you’re looking to make lifestyle changes and manage your diabetes, this study could be an excellent opportunity to receive support and resources tailored to your needs.

Gender

ALL

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.