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  • An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes Rochester, Minn.

    The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.

  • Assessment of Maternal and Fetal Outcomes in Pregnancy with Type 1 Diabetes Mellitus and Controls Rochester, Minn.

    The purpose of this study is to retrospectively and prospectively compare maternal and fetal/newborn clinical outcomes in age-matched pregnant patients with T1D and healthy controls and to assess the relationship between glycemic variability and pregnancy outcomes in the current era.

  • Automated Insulin Delivery in Elderly with Type 1 Diabetes (AIDE T1D): A Randomized Cross-over Trial Evaluating Automated Insulin Delivery Technologies on Hypoglycemia and Quality of Life in Elderly Adults with Type 1 Diabetes (AIDE T1D in Elderly) Rochester, Minn.

    The study is being done to find out if low blood sugar (hypoglycemia) can be reduced in people with type 1 diabetes (T1D) 65 years and older with use of automated insulin delivery (AID) system.

    The device systems used in this study are approved by the Food and Drug Administration (FDA) for diabetes management. We will be collecting data about how they are used, how well they work, and how safe they are.

  • Control-IQ Technology in Individuals with Type 2 Diabetes (2IQ) (2IQ) Rochester, Minn.

    The purpose of this study is to evaluate 6 weeks of home use of the Control-IQ automated insulin delivery system in individuals with type 2 diabetes.

  • CPDPC16-04: Evaluation of a Mixed Meal Test to Diagnosis and Characterize Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT) Rochester, Minn.

    The purpose of this study is to develop a blood test to distinguish various causes of diabetes by evaluating patients who have developed diabetes within the last 3 years, but we will also enroll a small number of patients with long-term diabetes and normal blood sugars for comparison. 

    Diabetes mellitus is a common condition which is defined by persistently high blood sugar levels.  This is a frequent problem that is most commonly due to type 2 diabetes.  However, it is now recognized that a small portion of the population with diabetes have an underlying problem with their pancreas, such as chronic pancreatitis or pancreatic cancer, as the cause of their diabetes.  Currently, there is no test to identify the small number of patients who have diabetes caused by a primary problem with their pancreas.

     

  • Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease (FLOW) Rochester, Minn.

    The purpose of this study is to evaluate whether or not semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will receive semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.

  • Effectiveness and Safety of Dexcom Continuous Glucose Monitoring Systems in Non-Critically Ill Patients in the Inpatient Setting Rochester, Minn.

    The purpose of this study is to assess the effectiveness and safety of the Dexcom G6 Continuous Glucose Monitoring System when used in non-critically ill hospitalized patients on glucose control. Participants will wear up to three (3) Dexcom sensor configurations, on the arm and on the abdomen.

    Hospitalized patients with a stay for a minimum of 2 days in which they are on treatment to manage glucose will participate in the study. There will be no purposeful glucose manipulation since the CGM will be used in blinded mode. Data to determine the accuracy of the CGM in comparison with YSI will be collected through day 5 of CGM wear. Subjects will continue to wear the CGM until their discharge from the hospital up to 10 days of wear. The trial is designed to have at least two blood collection sessions to measure blood glucose on the YSI instrument per patient on different days and times of the day. Blood draws will be performed for periods of 6 hours each at 30-minute intervals on separate days for each participating patient. Day of YSI sessions should be on different sensor wear days. Every attempt will be made to obtain equal numbers of YSI sessions on each day (days 1-5). However, it is anticipated that fewer subjects will remain hospitalized for the full 5 days, so there will likely be more YSI sessions on days 1-3.

     

  • Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes (EWIS) Rochester, Minn.

    The objective of this study is to evaluate the EWIS in patients with type 1 diabetes on insulin pump therapy.

    This study is a multi-center, non-randomized, prospective single arm study with type 1 patients with diabetes on insulin pump therapy with Continuous Glucose Monitoring (CGM).

    A total of up to 300 subjects will be enrolled at up to 20 investigational centers in the US in order to have 240 subjects meeting eligibility criteria. Each subject will wear their own MiniMed™ 670G insulin system. Each subject will be given 12 infusion sets to wear (each infusion set for at least 174 hours, or until infusion set failure if this occurs before 174 hours). The infusion set with the longest length (43 in) will be used for this study. Subjects will change insulin reservoirs at least every 174 hours. The infusion set(s) or reservoir(s) can be replaced independent of each other as referenced in the subject instructions. The time of infusion set insertion will be taken from Daily Log.

  • Glycemic Variability and Fluctuations in Cognitive Status in Adults with Type 1 Diabetes (GluCog) (GluCog) Rochester, Minn.

    The objective for thisstudy is to characterize the impact of glycemic excursions on cognition in Type 1 Diabetes (T1D) and determine mediators and moderators of this relationship. This study will allow us to determine how glycemic excursions impact cognition, as well as to identify mediators and moderators of this relationship that could lead to novel interventions.

  • Individualized Medicine Approach for Pancreas and Pancreas/Kidney Transplantation in Type 1 Diabetes Mellitus Rochester, Minn.

    The purpose of this study is to measure and characterize specific immune cell abnormalities found in patients who have type 1 diabetes and may or may not be on the waiting list for either a pancreas alone or a pancreas and kidney transplant.

  • Multi-center, Randomized, Adaptive, Controlled Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System at Home Rochester, Minn.

    The purpose of this study is to demonstrate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A diverse population of patients with type 1 diabetes will be studied. The study population will have a large range for duration of diabetes and glycemic control, as measured by glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)

  • Randomized, parallel group, dose escalation trial of Pioglitazone versus Empagliflozin for Chronic Pancreatitis/recurrent acute pancreatitis associated Diabetes Mellitus: The PEP-DM Trial Rochester, Minn.

    The purpose of this study is to evaluate efficacy of PIO versus EMPA to improve glycemic control in people with CP or RAP associated with DM (CP-DM). To evaluate mixed meal response in PIO versus EMPA group to better understand physiology of both therapies in CP-DM.

  • Testing And Refinement Of PACTAID App In Patients With Type 1 Diabetes To Help Manage Exercise While On Automated Insulin Delivery System (PACTAID) Rochester, Minn. The purpose of this trial is to test and refine the PACTAID smart phone application in adults with type 1 diabetes mellitus to help manage exercise while on automated insulin delivery systems with the goal of improving glycemic control during and after exercise as well as improving multiple other cardiovascular risk factors.
  • Type 1 and Type 2 Diabetes registry Rochester, Minn., Mankato, Minn.

    The purpose of this research is to create a single registry for type 1 and type 2 diabetes at Mayo Rochester and affiliated Mayo sites.

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