Continuous Glucose Monitoring for Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Signos Inc
Must not be taking: Clozapine, Hydroxyurea, Insulin
Disqualifiers: Type 1 diabetes, Eating disorders, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that you do not take Clozapine, Hydroxyurea, or any form of insulin. If you are currently taking any of these, you would need to stop before participating.
What data supports the effectiveness of the treatment Continuous Glucose Monitor Device for Type 2 Diabetes?
Research shows that continuous glucose monitoring (CGM) helps people with diabetes, including type 2, by providing detailed information about their blood sugar levels. This helps them manage their condition better, leading to improved blood sugar control and reduced risk of low blood sugar episodes.
12345Is continuous glucose monitoring safe for humans?
Continuous glucose monitoring (CGM) systems are generally safe for humans, with a large study showing no serious related adverse events over multiple uses. Some minor issues like sensor site infections and skin irritation can occur, but they are relatively rare.
25678How is continuous glucose monitoring different from other treatments for type 2 diabetes?
Continuous glucose monitoring (CGM) is unique because it provides real-time, continuous tracking of glucose levels, allowing for better management of blood sugar without increasing the risk of low blood sugar episodes. Unlike traditional methods that require finger-prick blood tests, CGM uses a sensor to measure glucose in the fluid under the skin and can alert users to changes in glucose levels.
19101112Eligibility Criteria
This trial is for adults with Type 2 Diabetes who are not using insulin. Participants must be willing to use a Continuous Glucose Monitor (CGM) device, engage with the Signos mHealth platform on their smartphone, and have medical clearance to make diet and lifestyle changes. They should not have severe hypoglycemia history, certain metabolic disorders, an eating disorder, or be taking specific medications like Clozapine.Inclusion Criteria
Be a Signos mHealth (mobile/web-based) user
I have been diagnosed with Type 2 Diabetes based on my latest Hg A1c test results.
I am 18 years old or older.
+6 more
Exclusion Criteria
I have been diagnosed with Type 1 Diabetes.
I have been diagnosed with an eating disorder like anorexia or bulimia.
You have had a bad skin reaction to adhesive in the past.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants use the Signos app and CGM to receive personalized health and wellness recommendations
5 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 year
Participant Groups
The study tests if using a CGM device along with the Signos mobile health platform can help people with Type 2 Diabetes manage their weight better by promoting exercise and healthy eating habits. It's based on previous findings that suggest monitoring glucose levels can inspire beneficial behavioral changes.
1Treatment groups
Experimental Treatment
Group I: Signos digital health app and CGMExperimental Treatment1 Intervention
For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness.
Continuous Glucose Monitor Device is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Continuous Glucose Monitor Device for:
- Diabetes management
- Monitoring of glucose levels in individuals with diabetes
🇺🇸 Approved in United States as Continuous Glucose Monitor Device for:
- Diabetes management
- Monitoring of glucose levels in individuals with diabetes
- Adjunctive use in the management of type 1 and type 2 diabetes
🇨🇦 Approved in Canada as Continuous Glucose Monitor Device for:
- Diabetes management
- Monitoring of glucose levels in individuals with diabetes
🇯🇵 Approved in Japan as Continuous Glucose Monitor Device for:
- Diabetes management
- Monitoring of glucose levels in individuals with diabetes
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
SignosPalo Alto, CA
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Who Is Running the Clinical Trial?
Signos IncLead Sponsor
References
Continuous glucose monitoring: current use and future directions. [2022]Continuous glucose monitoring (CGM) is an emerging technology that provides a continuous measure of interstitial glucose levels. In addition to providing a more complete pattern of glucose excursions, CGMs utilize real-time alarms for thresholds and predictions of hypo- and hyperglycemia, as well as rate of change alarms for rapid glycemic excursions. CGM users have been able to improve glycemic control without increasing their risk of hypoglycemia. Sensor accuracy, reliability, and wearability are important challenges to CGM success and are critical to the development of an artificial pancreas (or closed-loop system).
Continuous glucose monitoring: A review of the technology and clinical use. [2022]Continuous glucose monitoring (CGM) is an increasingly adopted technology for insulin-requiring patients that provides insights into glycemic fluctuations. CGM can assist patients in managing their diabetes with lifestyle and medication adjustments. This article provides an overview of the technical and clinical features of CGM based on a review of articles in PubMed on CGM from 1999 through January 31, 2017. A detailed description is presented of three professional (retrospective), three personal (real-time) continuous glucose monitors, and three sensor integrated pumps (consisting of a sensor and pump that communicate with each other to determine an optimal insulin dose and adjust the delivery of insulin) that are currently available in United States. We have reviewed outpatient CGM outcomes, focusing on hemoglobin A1c (A1C), hypoglycemia, and quality of life. Issues affecting accuracy, detection of glycemic variability, strategies for optimal use, as well as cybersecurity and future directions for sensor design and use are discussed. In conclusion, CGM is an important tool for monitoring diabetes that has been shown to improve outcomes in patients with type 1 diabetes mellitus. Given currently available data and technological developments, we believe that with appropriate patient education, CGM can also be considered for other patient populations.
Continuous Glucose Monitoring for the Internist. [2022]Continuous glucose monitoring system is a convenient wearable device that provides glucose readings from the interstitial fluid every few minutes. Continuous glucose monitoring has revolutionized diabetes care. Patients with type 1 diabetes mellitus and type 2 diabetes mellitus, regardless of the type of treatment regimen, can benefit from continuous glucose monitoring. Continuous glucose monitoring systems provide patients with diabetes and their providers with an ambulatory glucose report that summarizes and also gives graphical representations of the glucose data. This wealth of information helps to better understand patients' glycemic patterns, and thereby reduces hemoglobin A1c and hypoglycemia.
Clinical Implications of Accuracy Measurements of Continuous Glucose Sensors. [2018]The accuracy of a continuous glucose monitor (CGM) now supports its use by persons with diabetes and clinicians caring for them. This article reviews measures of CGM accuracy, factors contributing to accuracy, comparative accuracy assessment, clinical implications of CGM sensor accuracy, and recent clinical trials that have demonstrated the utility of CGMs.
Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor. [2019]Users of continuous glucose monitoring (CGM) systems are concerned with the frequency of inserting and calibrating new sensors, with sensor accuracy and reliability throughout the sensor's functional life, and with the risks associated with inaccurate sensor readings.
Clinical overview of continuous glucose monitoring. [2021]Continuous glucose monitoring (CGM) is now available from several companies in the United States for purchase or research studies. This article provides an overview of these devices and reviews the use of sensors for managing diabetes in "real time," as well as the use of retrospective analysis of CGM results.
Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023]Adverse events for continuous glucose monitors (CGMs) represent a significant issue for people with diabetes with 281 963 CGM adverse events occurring in 2022. The process to obtain adverse events and the US Food and Drug Administration (FDA) database that contains them are reviewed.
Real-World Safety of an Implantable Continuous Glucose Sensor Over Multiple Cycles of Use: A Post-Market Registry Study. [2020]Previously, the safety and accuracy of the Eversense continuous glucose monitoring (CGM) system were characterized in three pivotal trials among individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) with a single 90- or 180-day sensor insertion-removal cycle. The Post-Market Clinical Follow-up (PMCF) registry is a prospective study evaluating the long-term safety and performance of the Eversense CGM system over multiple sensor insertion-removal cycles among adults with T1D and T2D. All patients who had a sensor subcutaneously implanted across 534 participating centers in Europe and South Africa from June 2016 to August 2018 were enrolled. Adverse events (AEs) were recorded at each visit and patients were instructed to inform their clinic if they experienced any AEs between visits. AEs were adjudicated for relatedness to the device, procedure, or drug (dexamethasone acetate). The primary safety endpoint was the rate of related serious adverse events (SAEs) through four sensor insertion-removal cycles. The registry enrolled 3023 patients. As of last follow-up, 5417 sensors had been inserted with a total of 1260 patient-years (PYs) of follow-up: 969 patients had used the system for at least 6 months and 173 patients had used the system for at least 1 year. No related SAEs were reported. The most frequently reported related AEs were sensor location site infection (0.96%; 2.46 events per 100 PYs), inability to remove the sensor upon first attempt (0.76%; 1.90 events per 100 PYs), and adhesive patch location site irritation (0.66%; 1.59 events per 100 PYs). One nonserious allergic reaction to lidocaine was reported, which resolved with administration of an antihistamine. The full intended sensor life was achieved by 91% of 90-day sensors and 75% of 180-day sensors. The PMCF registry provides real-world evidence that the Eversense CGM system is safe over multiple cycles of use.
An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. [2023]Continuous Glucose Monitoring (CGM) is a key tool for insulin-treated people with diabetes (PwD). CGM devices include both real-time CGM (rtCGM) and intermittently scanned CGM (isCGM), which are associated with an improvement of glucose control and less hypoglycemia in clinical trials of people with type 1 and type 2 diabetes.
Device profile of the eversense continuous glucose monitoring system for glycemic control in type-1 diabetes: overview of its safety and efficacy. [2022]Continuous glucose monitoring (CGM) systems offer real-time data to facilitate diabetes management. The novel Eversense CGM has been approved in Europe and the US. The unique characteristics are the fully implantable sensor and the sensor life up to 180 days.
Usability and Teachability of Continuous Glucose Monitoring Devices in Older Adults and Diabetes Educators: Task Analysis and Ease-of-Use Survey. [2023]Continuous glucose monitoring (CGM) devices continuously sense and relay glucose concentration data from the interstitial fluid to a mobile phone or receiver. Older adults benefit from this continuous monitoring of glucose levels. Proper deployment of the sensing wire is facilitated by a specialized applicator.
Test-retest reliability of a continuous glucose monitoring system in individuals with type 2 diabetes. [2022]This study determined the test-retest reliability of a continuous glucose monitoring system (CGMS) (iPro™2; Medtronic, Northridge, CA) under standardized conditions in individuals with type 2 diabetes (T2D).