NCT05874635Active, not recruiting
Signos DM2 Empowerment Study (SIGNOS-CGM-EMPOWER-201-2022)
Use of Signos mHealth Platform in Participants With Non-Insulin Dependent Type 2 Diabetes: Weight and Blood Glucose
Source: ClinicalTrials.gov · Last updated 29 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20000 (estimated)
- First submitted
- 16 May 2023
- Start date
- 11 May 2023
- Primary completion date
- 10 May 2028
- Lead sponsor
- Signos Inc
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT05874635
What you commit to
- Study type: Interventional
- Planned participants: 20000
- From 11 May 2023 to the primary completion date, 10 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Type 2 Diabetes currently using insulin or most recent A1c ≥10%
- Currently taking any of the following medications: Clozapine, Hydroxyurea, or any form of insulin.
Other illness
- Medical diagnosis of Type 1 Diabetes
- 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)
Lab values
- Severe hypoglycemia \<54 mg/dl resulting in seizure or unconsciousness, or requiring assistance/EMS/hospitalization - within 3 months prior to enrollment
Other
- Intolerable skin reaction from adhesive
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Signos Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.