March 09, 2023
TITLE: Use of Signos mHealth Platform in Participants with Non-Insulin Dependent Type 2 Diabetes: Weight and Blood Glucose Level Optimization Program
SHORT TITLE: The Signos DM2 Empowerment Study
PROTOCOL NO.: SIGNOS-CGM-EMPOWER-201-2022
WCG IRB Protocol #20226944
SPONSOR: Signos Inc.
INVESTIGATOR: Stephanie Kim, M.D., MPH
2625 Middlefield Road #720
Palo Alto, CA 94306
STUDY-RELATED PHONE NUMBER(S): (650) 263-4502 (24 Hours)
Taking part in this research is voluntary. You may decide not to participate, or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled.
If you have any questions, concerns, or complaints or think this research has hurt you, talk to the research team at the phone number(s) listed in this document.
Taking part in this study is voluntary.
Your participation in this study is voluntary. You do not have to be in this study if you do not want to, and you can leave the study at any time. If you are an employee of Signos Inc., your decision to participate or not will not affect your employment. This study is being conducted by Stephanie Kim, M.D. and her team. Please read all sections of the informed consent document.
We ask that you read this document carefully and ask any questions you may have before agreeing to be in the study. After reading the consent form, if you would like to participate, you will be asked to sign this form. You will be given a signed copy of the consent form for your records.
What is the purpose of this study? The purpose of the study is to use continuous glucose data for weight optimization and general wellness for participating non-insulin dependent type II diabetic Signos members. Signos utilizes small changes in diet, exercise, eating, and lifestyle habits to help improve general health. The Signos app will integrate the data to recommend customized solutions to alter lifestyles to optimize weight management. The Signos smartphone app (iOS/Android) uses an algorithm to incentivize subjects to incorporate healthy habits. The Signos smartphone app will use CGM (continuous glucose monitoring) data for prolonged retention of healthy habits.
Signos app utilizes a fee-based subscription plan for the duration of choice for general wellness and weight optimization. As one of the Signos subscribed members, you are being asked to take part in this study. Members who have a history of non-insulin dependent type 2 diabetes (NID-T2D) that are part of Signos fee-based subscription app via smartphone are asked to participate in this study for assessing effect of continuous glucose monitoring for general wellness and weight optimization.
How many people are we expecting to take part in this study? If you agree to participate, you will be one of about 20,000 subjects who will be participating in this study. Your participation will last up to 6 years. The Signos app will collect CGM data for up to 5 years and one year of additional follow-up after the cessation of period of use of CGM.
Will you benefit from taking part in this study? You may or may not personally benefit from being in this research study. Some of the potential benefits of study participation may include weight management (e.g. fat loss), development of healthy eating habits including portion control, elimination of frequent snacking, reduced portion sizes and identification of irregular blood glucose levels, etc., but this cannot be guaranteed. We hope that the CGM information integration will provide you with recommendations to help you manage your weight and blood glucose effectively.
Who can participate in the study? To take part in this study, you must be or have the following:
There are some exclusion criteria that may prevent you from being part of the study. You will not be able to participate in the study if you have certain medical conditions. The study staff will explain these to you. In addition, you cannot participate if you are pregnant (if you become pregnant during the study, you may withdraw and re-join when you are not pregnant anymore).
What does this study involve? Once you are interested, information about study procedures and requirements will be provided for your review. If you decide to participate, the study team will review inclusion and exclusion criteria and an informed consent process will be completed in the Signos platform. A telemedicine physician will review your eligibility and prescribe a CGM via a designated pharmacy. The pharmacy will ship the CGM with instructions to the participant. The study will assess how well CGM data works in customizing your weight management program using an integrated algorithm of the Signos mHealth smartphone app. The CGM will measure your glucose level in the fluid under the skin. It consists of a sensor that is inserted into the skin, a transmitter attached to the sensor, and a display device. Approximately every 5 minutes the transmitter sends glucose readings to the display device. The Signos app stores the readings in a “real-time” mode where the numbers from the transmitter are shown on the Signos app display continuously.
Your documentation will be reviewed by an independent physician. A prescription for CGM is written by the physician to a designated pharmacy. You will receive a study kit along with the CGM from the study sponsor with video instructions on how to use the CGM. The kit will include education and training on the CGM system that will provide your glucose data. The CGM system to be used in the study is made by Dexcom, Inc. The CGM kit has a transmitter and appropriate number of sensors corresponding to your subscription plan. The sensor has a plastic body and contains a thin, small needle and sensor wire the size of a human hair. Once inserted, the needle is removed, and the sensor wire remains. The transmitter snaps on top of the sensor, and an athletic patch is provided that can be optionally applied to further affix the sensor in place. The sensor wire measures the glucose level in the fluid beneath the skin approximately every 5 minutes.
This information is sent by the transmitter to the display device. The sensor will alert you when it needs to be replaced. The first insertion will be detected by the study team via the Signos app. The removal and next insertions will also be recorded in the app. The Dexcom sensor at times may cause false high sensor readings (glucose is not affected) if higher than the maximum dose (e.g., greater than 1 gram or 1000 mg. every 6 hours) of acetaminophen (the ingredient in Tylenol) is used. Therefore, you should not use a higher than the maximum dose (e.g., greater than 1 gram every 6 hours) of acetaminophen and medications containing acetaminophen for at least 24 hours before sensor insertion and while the sensor is being used. You can take the standard or maximum dose of acetaminophen of 1 gram (1,000 mg) every 6 hours and still use the Dexcom CGM. Please update your information in the mHealth app if you are taking acetaminophen-containing medicine for a short interval.
During the course of the study, study team will integrate CGM data to other information (e.g. basic demographics, activities, identification and withdrawal of food using a variety of techniques such as gross pictures, motivational tools, coping skills to avoid comfort eating and white noise etc.) that are standard features of the Signos app. Amount of food, snacking panel, and some of the other features on the app are integrated to provide customized recommendations that motivate your engagement in a healthier lifestyle. Thus, your participation in this study requires the use of Dexcom CGM (glucose data) integration with diet, exercise, eating habits, water, food intake, sleep habits, etc. in the Signos adaptive algorithm. The app will provide you personalized recommendations for lifestyle changes.
You will be encouraged to implement changes in your daily habits for weight optimization using various rewards and incentives. You will have the option to use this weight optimization program with your friends and family as fostering camaraderie, encouraging fitness activities, and promoting healthier habits encourage retentive performance. You will also have the option to invite your friends and create competitive requests to work together in achieving goals toward weight optimization. Program participants will have the option to work out together, swap healthy recipes, and talk about their goals. Consider creating long-term initiatives, such as activity groups, healthy cooking classes, or yoga, bets, clubs, that will help participants extend their health success long after the challenge ends.
You will be asked to provide your clinical history of diabetes diagnosis (hemoglobin A1c test). The Signos clinical study team cannot provide individual diabetes counseling and it will be your responsibility to follow-up with your physician for your diabetes care. If you wish, the study team may assist you in locating diabetes care. At any time during the study, if your hemoglobin A1c test reaches greater than 10% over a continuous period of up to three (3) months, we will refer you to your physician for evaluation and further treatment and you will no longer be part of this study. You will be asked to visit your primary care provider (PCP) for diabetes education, interventional pharmacological treatment, care, and follow-up.
Study will not collect any physical specimen (e.g., blood, urine, sputum, etc.) during the course of your participation. You will be asked to answer questionnaires during the course of your participation.
What are the options if you do not want to take part in this study? Your participation in this study is voluntary. You do not have to be in this study if you do not want to, and you can leave the study at any time. You will not be subject to any penalties or lose any services, benefits, or rights to which you would be otherwise entitled if you chose not to be in the study or if you leave the study early. Your alternative to being in this study includes participate in structured medical or activity weight optimization programs. You can continue using the Signos app without being in the study.
What are the risks involved with being enrolled in this study?
This study involves an investigational device Dexcom CGM and Signos App because the US Food and Drug Administration (FDA) has not approved this device and app for weight optimization in the non-insulin dependent type 2 diabetes population.
During the study, your CGM data may show out-of-range data indicating hyper or hypo-glycemia. You will be notified in the real-time about your glucose and/or alerted to contact your primary care physician for further evaluation. Participants or their insurance will be responsible for any co-pays resulting from such medical visits and follow-up care to manage diabetes.
You will also require a smartphone with a data plan to be enrolled in the study. You will be responsible for all data charges you incur using the Signos App. The research team will not accept responsibility for data overage fees from your smartphone carrier.
You may feel uncomfortable answering some of the questions. You can choose to skip or stop answering questions at any time. Data will be utilized to update the algorithms and after the end of the study, all identifiable data about you will be de-identified, meaning we may retain and share certain elements of the study records for future research, but we will replace your identifying information with a code that does not directly identify you.
This research involves the potential risk of accidental release of confidential information. We are careful to ensure that the information you voluntarily provide to us is as secure as possible; however, you must be aware that transmissions over the Internet cannot be guaranteed to be completely secure. Although reasonable efforts have been taken, privacy and anonymity during Internet interactions cannot be guaranteed. It is possible that additional information beyond that collected for research purposes may be captured and used by others not associated with this study. The web includes elements that are not always evident, including online tracking mechanisms. As you move from one site to another, third parties not involved in this research, may “watch” your online activity, including your visit to our research site. That third party may employ security and privacy policies different than ours, over which we have no control.
The research may involve risks to the subject which are currently unforeseeable.
Your private information and your medical record will be shared with individuals and organizations that conduct or watch over this research, including:
Risk of Dexcom CGM
Can I be part of the study if I am not interested in weight management? Yes, if you are not interested in weight management, we are still interested in your participation. The app will provide lifestyle recommendations for general wellness.
Other important items you should know:
Leaving the study: You may choose to stop taking part in this study at any time for any reason. If you decide to stop taking part, it will have no effect on the quality of medical care. The investigator reserves the right to stop the study participant from continuing without participant consent.
New Information: New information related to this research will be made known to you when it becomes available. This may affect your decision to stay in this study.
Funding: The study is funded and managed by Signos Inc., where multi-disciplinary experts are dedicated to utilizing CGM data and optimizing the weight management program by providing customized recommendations to individual participants.
What about the costs of this study? You will not be paid to participate in this study. You or your health insurance plan may have to pay for medical costs including CGM that are part of this study. If you have insurance, your insurance company may or may not pay for these costs. If you do not have insurance, or if your insurance company refuses to pay, you will have to pay. You should discuss any questions you have about costs with the study doctor or study team.
If you are diagnosed with any health conditions (e.g., diabetes related complications etc.) during the course of participation, all medical referrals will be covered through your regular healthcare insurance. You or your insurance plan will be expected to pay for the costs of such referral medical care.
What if I am injured because of taking part in this study? If you are injured or get sick because of being in this research, seek medical treatment as you would if you were not in the research (if it is an emergency) or call the study doctor. The study doctor will refer you to medical treatment. Your insurance may be billed for this treatment. No other payment is routinely available from the study doctor or sponsor.
Financial interest disclosure: Members of the study team, Dr. Sharam Fouladgar-Mercer, Dr. William Dixon, and Dr. Khemraj Hirani have disclosed that they have a personal interest related to this study, they own private equity stock in, and/or have received consulting fees from, the sponsor. Please ask any questions you have about this. If you require further information, please contact the study doctor or WCG IRB to ask questions or discuss concerns. There is also a study independent ombudsman who is available for any further information.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Whom should you call with questions about this study? If you have any questions, concerns, or complaints about this study, or feel you may have had a reaction to the investigational product or you may have experienced a research-related injury, contact: Dr. Stephanie Kim, M.D. at email@example.com or (650) 263-4502 24 hours. If you have questions, concerns, or complaints, or think this research has hurt you, talk to the research team at the phone number listed above.
This research is being overseen by WCG IRB. WCG IRB is a group of people who perform an independent review of research studies. You may talk to them at 855-818-2289, firstname.lastname@example.org if:
I have read the above information about Signos DM2 Empowerment Study and have been given time to ask questions. I agree to take part in this study, and I have been given a copy of this signed consent form.
Electronic signature of participant Date electronically signed
Name of person obtaining consent Date
Who may use or see your health information?
By signing this form, you allow the research team to use your health information (such as the information in your medical record, glucose measurements from the Dexcom CGM, and data you input into the app) and give it to others involved in the research. The sponsor’s research team includes the study investigator and others working on this study at Signos Inc., its affiliates, and collaborators. It may also be given to the FDA and IRB, as mentioned in the consent form. The information collected for this study may be used by researchers and sponsor of the study to carry out the study and check that it is being done properly. Some of the information used in this study, called Protected Health Information ("PHI"), is protected by federal privacy laws. By signing this consent form, you give your permission to have your PHI collected, used, and disclosed for the purposes of this study.
After the study staff or study doctor discloses your PHI to others, it could be re-disclosed and no longer protected by federal privacy laws.
Your permission to use your health information for this study will be good until December 31, 2070. During this study, you and others who take part in the study may not have access to the study data. You may ask for study data once the study is over. You have a right to receive a copy of the information in your medical record at any time. It is possible for a court or government official to order the release of study data including information about you.
What if you decide not to give permission to use and share your personal health information?
If you do not allow the use of your CGM and health information for this study, you may not take part in this study. If you choose to stop taking part in this study, you may cancel permission for the use of your health information. You should let the researcher know if you want to cancel your permission. The Signos team will assist you in putting your wishes in writing. Information collected for the study before your permission is canceled will continue to be used in the research.
Electronic signature of participant Date electronically signed