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303 active trials for Diabetes

Improve Timely Referral Flow and Compliance of Diabetic Retinopathy Patients

An effective referral system helps to ensure a close relationship between all levels of the health system and ensures clients receive optimum care at the appropriate level and at affordable cost, and hospital facilities are used optimally and cost-effectively. A referral system requires consideration of all its important components that can be then adjusted to the local situation. Being a system, the important components of a referral system are Health system issues (Service providers, Referral protocols, Communication & transportation provide), Referring facility& Referral practicalities (Client & their condition, Protocols of care, Care provider & documents, Referral decision, Outward referral form, Communicate with referral facility, Client information, Referral register), Referral facility& Referral practicalities (Client with referral form, Treat the client with the document, Rehabilitation plan, Back referral form, Feedback to referring facility, Referral register) and Supervision and capacity building (Referral monitoring, Ensure back referral, Feedback and training to facility staff and Feedback to central level) ((USAID), 2012). There are mainly two limitations on referring Diabetic Retinopathy patients. Patient-related reasons: lack of awareness, belief, cost, distance from screening/ treatment centers, discomfort from dilating drops, efforts to attend yet another center, fear of laser treatment, fear of its impact on quality of life and jobs, lack of family support and guilt surrounding the failure to control blood sugar. Provider-related reasons are poor counseling and advisory services about ocular complications for patients with diabetes, inefficient call and recall system, long waiting times for screening or treatment, and complicated referral mechanism. Lumbini eye institute is a comprehensive tertiary eye care center in western Nepal. In spite of 19 peripheral referral centers under it, there is a poor inflow of Diabetic retinopathy patients as against the estimated disease burden in the catchment area. The objective of our study is to improve timely referral flow from referring centers and compliance with referral cases after the intervention. In order to meet our objective, the investigators tend to implement patient counseling at referral centers, a referral tracking system, and a fast-track mechanism for patients at base hospitals.

Start: March 2021
The Measurement of VItal SIgns by Lifelight® Software in comparisON to the Standard of Care - Multi-site Development

AIM: To advance the development and accuracy of the Lifelight® app for the measurement of vital signs, therefore developing a non-invasive and easy-to-perform means of measuring vital signs which can be implemented across a wide range of settings, both within hospitals and out in the community. METHOD: Lifelight® is a computer program ("app") for measuring vital signs which can be used on smart devices that contain a camera. It is able to measure all of the vital signs by measuring very small changes in skin colour that occur each time the heart beats. This means that it does not need to touch the patient. The investigators believe this could be an effective way of measuring vital signs, especially during the COVID-19 pandemic when prevention of cross-contamination between patients is essential. Patients are also likely to be reassured by a contactless approach. The app uses data from looking at a person's face to calculate the vital signs. This is possible because there are tiny changes in facial skin that occur each time the heart beats. The investigators believe Lifelight® could be an effective way of measuring vital signs. The app is still under development, which means that it is still "learning" the best match between the information it collects from the face and the values of vital signs measured using the standard equipment. The app should become more accurate in calculating the vital signs as it sees more and more information from patients. So far, the app has seen data from inpatients, outpatients, patients attending GP surgeries and healthy people. This has improved its accuracy in measuring vital signs. However, the app needs to see more information so that it can be sufficiently accurate for specific clinical applications such as long-term monitoring of hypertension. To do this, it particularly needs to see information from people with abnormal blood pressures and blood oxygen levels. In order to capture the full range of observations, the app will need to be trialled with some of the most critically ill patients - some of these will not have capacity to consent to participation in the study. It also needs to see more data from people with different skin tones so the investigators can be sure it is accurate for all patients. To do this, the investigators will recruit people who are attending one of two hospitals, either as an inpatient, an outpatient, a friend/relative of a patient, or a member of hospital staff. The exact number will depend on how quickly the app "learns" and how many of the vital signs are outside of the normal range. The investigators will take the participant's vital signs using standard clinical equipment whilst recording a video of their face. The investigators will use most of these measurements and video to teach the app how to become more accurate at measuring vital signs. The investigators will keep the remaining data separate and use it to test how accurate the app is. All of the data will be kept securely. The investigators will also collect feedback from participants and healthcare staff on their experiences using the app and information that allows us to assess whether there are any savings to the healthcare economy through use of this technology.

Start: April 2021
Prebiotics and Metformin Improve Gut and Hormones in Type 2 Diabetes in Youth (MIGHTY-fiber)

Background: Metformin is a pill youth with type 2 diabetes take. It can cause side effects like diarrhea and upset stomach. Researchers want to see if a fiber supplement can help decrease these side effects. Objective: To see if a prebiotic fiber supplement helps improve the gastrointestinal side effects of people taking metformin and helps with their blood sugars. Eligibility: People ages 10-25 with type 2 diabetes who are taking or will take metformin Design: Participants will be screened with: Physical exam Medical history Blood and urine tests Meeting with a nutritionist Participants will stop taking all diabetes medication for 1 week. They will then take metformin by mouth for 1 week. They will be randomly assigned to take either a fiber supplement or a placebo by mouth during the same week. They will then stop all study treatments for 2-3 weeks. Then they will restart metformin for 1 week. The groups that received the fiber versus the placebo will be reversed. All participants will then continue taking metformin and take the fiber for 1 month. Participants will have 6 visits over about 2 months. These will include: Blood and urine tests Meal tests: A plastic tube will be inserted in the participant s arm vein for blood draws. They will drink a special meal. DXA scan: Participants will lie on their back while the scan measures their body fat and muscle. While they are home, participants will: Fill out daily surveys online Wear daily activity and blood sugar monitors Collect their stool Eat only certain foods for two 1-week periods...

Start: March 2020
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy

Background: - Generalized lipodystrophy can cause high blood fat levels and resistance to insulin. This can lead to health problems including diabetes. Researchers have found that the drug metreleptin improves health in people with this disease. Objective: - To test the safety and effectiveness of metreleptin. Eligibility: People ages 6 months and older with generalized lipodystrophy who: have received metreleptin through NIH studies AND cannot get it through approved or compassionate use mechanisms in their home country. Design: Participants will come to NIH approximately every 6 months during year one, then every 1 2 years. Financial assistance may be available for travel within the U.S. At visits, participants will get a supply of metreleptin to take home for daily injections. They will have: plastic catheter placed in an arm vein. blood tests, urine collection, and physical exam. oral glucose tolerance test, drinking a sweet liquid. ultrasound of the heart, liver, uterus, and ovaries. A gel and a probe are placed on the skin and pictures are taken of the organs. echocardiogram, which takes pictures of the heart with sound waves. Resting Metabolic Rate taken. A plastic hood is worn over the head while the oxygen they breathe is measured. Participants will have up to 3 DEXA scan x-rays per year. Participants may have: annual bone x-rays. liver biopsies every few years. A needle will be inserted into the liver to obtain a small piece. Participants will sign a separate consent for this. Participants must be seen regularly by their local doctors and have blood tests at least every 3 6 months at home.

Start: October 2014