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A Randomized Trial Evaluating the Efficacy and Safety of Control-IQ Technology in Adults with Type 2 Diabetes Using Basal-Bolus Insulin Therapy (2IQP) (2IQP)
Rochester, Minn.
The purpose of this study is to assess the safety, effectiveness, and quality of life of Control-IQ technology in adults with type 2 diabetes using basal-bolus insulin therapy.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Glycemic Variability Assessment in Complex Diabetes During Hospitalization
Rochester, Minn.
The purpose of this study is to assess the glycemic variability in patients with complex diabetes admitted in the hospital using a glycemic sensor.
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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.
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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)
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Open, Single Arm, Prospective, Multicenter Study of an Investigational Extended Wear Insulin Infusion Set During Home Use in People with Type 1 Diabetes
Rochester, Minn.
The purpose of this study is to assess the efffectiveness, safety, and tolerability of using the SteadiSet infusion set for insulin delivery when each set is used continuously for up to 7 days in adults with T1D, to provide data for regulatory submission.
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Performance Evaluation of an Advanced Algorithm with CGM in Adults, Adolescents, and Pediatrics (Zeus)
Rochester, Minn.
The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).
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Risk and Benefit Assessment of Pancreas Transplantation
Rochester, Minn.
The purpose of this study is to (i)assess glucose variability at pre specified time points after Pancreas Transplantation (ii) collect pre-specified serious adverse events after PT and in appropriate control groups (iii) assess mixed meal dynamics after pancreas transplantation.
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Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects Utilizing Lyumjev® insulin lispro-aabc
Rochester, Minn.
The purpose of this study is to evaluate the safety of utilizing insulin lispro-aabc in the MiniMed™ 780G System to support product and system labeling.
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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.
Closed for Enrollment
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A Pivotal Study of t:Slim X2 With Control-IQ Technology (DCLP3)
Rochester, Minn.
The objective of the study is to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial.
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A Randomized Clinical Trial to Assess the Efficacy and Safety of Continuous Glucose Monitoring in Individuals 60 Years Old or Older with Type 1 Diabetes - Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) (WISDM)
Rochester, Minn.
The primary objective of this study is to determine if continuous glucose monitoring (CGM) can reduce hypoglycemia and improve quality of life in older adults with type 1 diabetes (T1D).
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A Randomized Crossover Comparison of Model Predictive Control (MPC) Artificial Pancreas vs.Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) with Different Stress Assessments in the Outpatient Setting for Patients with Type 1 Diabetes
Rochester, Minn.
The purpose of this study is to compare the effectiveness and safety of an automated insulin delivery (AID) system using a model predictive control (MPC) algorithm versus Sensor-Augmented Pump/Predictive Low Glucose Suspend (SAP/PLGS) therapy with different stress assessments over a 4-week period.
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An Extension Study of t:Slim X2 With Control-IQ Technology
Rochester, Minn.
The purpose of this 3-month extension study (DCLP3 Extension) following a primary trial (DCLP3 or NCT03563313) to assess effectiveness and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial.
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Analysis of Biomarkers in Type 1 Diabetes Mellitus
Rochester, Minn.
The purpose of this study is to develop a better blood test to diagnose early kidney injury in type 1 diabetes.
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Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial Research Site Training Protocol
Rochester, Minn.
The purpose of this study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and then assess 24/7 in-home usability prior to initiating a large randomized controlled trial.
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Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial: A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor-Augmented Pump Therapy in the Management of Type 1 Diabetes (iDCL)
Rochester, Minn.
The objective of the study is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system.
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Diabetes Technology Clinic Patient Interviews
Rochester, Minn.
The study is designed to understand the confidence and competence level of patients with type 1 diabetes mellitus in their ability to make changes to their insulin pump.
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Evaluation of a Mixed Meal Test for Diagnosis and Characterization of Type 3c diabeTes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT) (DETECT)
Rochester, Minn.
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.
The goal of this study is to develop a test to distinguish these various causes of diabetes. To accomplish this goal, we will enroll a range of patients. Most of the patients enrolled for these groups will 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.
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Exploratory Study to Evaluate Bio-markers Associated with Improved Glucose Control in Type 1 Diabetes
Rochester, Minn.
The purpose of this study is to collect blood samples for biomarker assessment in type 1 diabetes prior to and at specific time points during closed loop control.
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Feasibility Study to Assess the Impact of Non-glucose Signals on Glycemic Control in Patients With Type 1 Diabetes on Sensor Augmented Insulin Pump
Rochester, Minn.
This clinical trial will identify exercise-related and emotional stress related effects on glycemic control in patients with type 1 diabetes using sensor-augmented pump (SAP) therapy.
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Feasibility Study with Personalized Closed Loop (PCL) (CIP326 PCL)
Rochester, Minn.
The purpose of this study is to collect device data to assist in the development of a Personalized Closed Loop (PCL) system.
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Hybrid Closed Loop Insulin Delivery System Data Collection (HYCLO) (HYCLO)
Rochester, Minn.
The purpose of this project is to collect data over the first year of clinical use of the FDA approved 670G closed loop insulin delivery system among patients with type 1 diabetes. The goal is to evaluate how this newly approved system impacts both clinical and patient-reported outcomes.
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Immune mediated diabetes due to PD 1 inhibitors
Rochester, Minn.
The purpose of this study is to identify immune mediated diabetes in patients treated with PD 1 inhibitors, and characterizing its clinical course, laboratory features and possible risk factors.
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Impact of Insulin Antibodies on Glucose Variability: An in vivo and in vitro Minimal Risk Study
Rochester, Minn.
The purpose of this study is to evaluate glucose variability in patients with type 1 diabetes (T1D) and insulin antibodies, to evaluate the clinical significance of insulin antibodies, and to establish an in vitro assay that would detect antibodies to insulin and insulin analogs.
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Impact of Physical Activity on Glucose Variability and Metabolomic Profiles in Children with Type 1 Diabetes
Rochester, Minn.
The purpose of this study is to use multiple devices to measure blood sugar changes and the reasons for these changes in healthy and diabetic children.
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INHALE-3: A 17-Week Randomized Trial and a 13-Week Extension, Evaluating the Efficacy and Safety of Inhaled Insulin (Afrezza®) Combined with Insulin Degludec (Tresiba ®) Versus Usual Care in Adults with Type 1 Diabetes
Rochester, Minn.
The purpose of this study is to compare the effectiveness and safety of an insulin regimen consisting of degludec plus inhaled insulin and CGM versus usual care consisting of MDI, AID, or a pump without automation, and CGM from baseline to week 17 in adults ≥ 18 years of age with T1D.
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Natural History of Diabetes after Total Pancreatectomy
Rochester, Minn.
The purpose of this study is to estimate the risk of diabetes related complications after total pancreatectomy. We will contact long term survivors after total pancreatectomy to obtain data regarding diabetes related end organ complications.
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Observational Study of Patient Important Outcomes in Pregnant Patients with Type 1 Diabetes Mellitus on Insulin Pump
Rochester, Minn.
The purpose of this study is to serve as a comparator group to a group of patients that will be managed with AP for varying periods of time during pregnancy.
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Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes.
Rochester, Minn.
Hypothesis: Increased contact with the diabetes care team throughout pregnancy will lead to improved glucose control during pregnancy.
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Risk prediction for immune checkpoint inhibitor associated diabetes mellitus and pituitary dysfunction
Rochester, Minn.
The purpose of this study is to identify risk factors for ICI associated diabetes mellitus and to assess the severity and natural course of this immune related adverse effect.
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Supervised Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated into the iAPS in Pregnant Patients with Type 1 Diabetes with Extension into Outpatient at Home
Rochester, Minn.
The purpose of this research is to test the safety and effectiveness of the interoperable Artificial Pancreas System Smartphone App (iAPS) in managing blood sugars in pregnant patients with type 1 diabetes.
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The International Diabetes Closed Loop (iDCL) Trial: A Randomized Crossover Comparison of Adaptive Model Predictive Control (MPC) Artificial Pancreas Versus Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) in the Outpatient Setting in Type 1 Diabetes (DCLP4)
Rochester, Minn.
The purpose of this study is to compare the effectiveness and safety of an automated insulin delivery (AID) study system using a Model Predictive Control (MPC) algorithm versus Sensor Augmented Pump (SAP) (which may or may not include PLGS; to be referred to as SAP) therapy in people with type 1 diabetes. A Pilot Phase involving up to 7 participants using the study system for 10-14 days will be conducted prior to the crossover trial.
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Unified Safety System (USS) Virginia Closed-Loop Versus Sensor Augmented Pump Therapy for Oversight Control in Type 1 Diabetes
Rochester, Minn.
The purpose of this study is to use the USS Virginia Closed-Loop system for overnight insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate the system's ability to significantly improve blood glucose levels. This protocol will test the feasibility of "bedside" closed-loop control - an approach comprised of standard sensor-augmented pump therapy during the day using off-the-shelf devices and overnight closed-loop control using experimental devices in an outpatient setting. The rationale for this study is as follows: we anticipate that closed-loop control may ultimately be adopted by patients with T1DM in a selective manner. Patient may choose to start using these systems for overnight control only, e.g. to alleviate the well documented fear of hypoglycemia while asleep. To test this paradigm of "bedside" closed-loop control, subjects will be studied with continuous glucose monitoring (CGM)-augmented usual pump therapy during the day followed by overnight use of USS Virginia Closed Loop Control.
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