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Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
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The primary objective of this project is to examine the impact of a continuous glucose monitoring (CGM) intervention on health and psychological outcomes in young children with type 1 diabetes (T1D).
Stanford is currently not accepting patients for this trial.
For more information, please contact Regan C Barley, 650-736-1517.
Lead Sponsor
Stanford Investigators
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Prepivotal Omnipod Horizon™ Automated Glucose Control System
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Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and outpatient setting.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Stanford Investigators
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The International Diabetes Closed Loop (iDCL) Trial: Protocol 4
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The investigators aim to compare the efficacy and safety of an AID system using an adaptive MPC algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) in people with type 1 diabetes.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Stanford Investigators
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Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial
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A 6-week crossover study will compare PLGS to SAP outcomes in adults and youth \> 6 years old with type 1 diabetes (T1D).
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Stanford Investigators
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Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes
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Randomized trial of youth aged 7-\<18 years with newly diagnosed stage 3 type 1 diabetes (T1D) to assess the effect of both (1) near-normalization of glucose concentrations achieved through use of a hybrid closed loop (HCL) system and (2) verapamil on preservation of β-cell function 12 months after diagnosis. Participants with body weight ≥30 kg (Cohort A) will be randomly assigned in a factorial design to (1) HCL plus intensive diabetes management or usual care with no HCL and (2) verapamil or placebo. Participants with body weight \<30 kg (Cohort B) will be randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes management or to usual care with no HCL.
Stanford is currently not accepting patients for this trial.
For more information, please contact Eliana Frank, 650-721-8782.
Stanford Investigators
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The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes
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The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for young children (2 yo to less than 6 yo) with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ryan Kingman, 650-736-4417.
Stanford Investigators
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Omnipod Horizon™ Automated Glucose Control System Preschool Cohort
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Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting, and an optional 12-month extension phase.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ryan Kingman, .
Stanford Investigators
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Pivotal Omnipod Horizon™ Automated Glucose Control System
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Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting and an optional 12-month extension phase.
Stanford is currently not accepting patients for this trial.
For more information, please contact Bruce Buckingham, MD, .
Stanford Investigators
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The Insulin-Only Bionic Pancreas Pivotal Trial
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This multi-center randomized control trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas (BP) System versus Usual Care (UC) during a 13-week study period. Participants may be enrolled initially into a screening protocol and then transfer into the RCT protocol, or they may enter directly into the RCT protocol. The RCT will be followed by an Extension Phase in which the RCT Usual Care (UC) Group will use the insulin-only configuration of the iLet Bionic Pancreas (BP) System for 3 months. At the completion of use of the BP system in the RCT only, participants will enter a 2-4 day Transition Phase and be randomly assigned to either transition back to their usual mode of therapy (MDI or pump therapy) based on therapeutic guidance from the iLet BP System or transition back to their usual mode of therapy based on what their own insulin regimens were prior to enrolling in the RCT.
There is an optional ancillary study to assess the safety of utilizing self-monitored blood glucose (SMBG) measurements instead of continuous glucose monitor (CGM) measurements as input into the iLet for \~48-60 hours. The Study is intended to mirror a real-world situation where CGM may not be available for an extended period of time (eg, user runs out of sensors and is awaiting new shipment).
Stanford is currently not accepting patients for this trial.
For more information, please contact Liana Hsu, BS, 650-725-3939.
Stanford Investigators
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Real-time Reminders To Decrease Late or Missed Meal Boluses
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This study is examining whether the Klue app is effective in detecting missed or late meal boluses in patients with Type 1 diabetes. The app is programmed onto an Apple Watch and will detect potential missed boluses from hand motion. It will send text alerts to the user asking if they have bolused. This is a pilot study and will assess whether there is a change in the number of missed meal boluses in the two weeks prior to each visit. If the findings are significant, this software can be integrated in future closed-loop algorithms for automatic insulin delivery.
Stanford is currently not accepting patients for this trial.
For more information, please contact Liana Hsu, BA, 650-725-3939.
Lead Sponsor
Stanford Investigators
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Longevity of Multi-Slitted Catheter With Lantern Technology
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To determine time to set failure when the Convatec Inset II with Lantern technology (Convatec Lantern) infusion set with multi-slitted catheter is worn for up to 10 days
Stanford is currently not accepting patients for this trial.
For more information, please contact Liana Hsu, BS, 650-725-3939.
Lead Sponsor
Stanford Investigators
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Full Day and Night Closed-Loop With DiAs Platform
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The overall aim of this proposed research is to determine the safety, feasibility and efficacy of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in children and adolescents with type 1 diabetes over multiple days in a diabetes camp setting. This will be addressed in two parts: 1) An in residence, outpatient study to determine safety and feasibility of the DiAs during 72 continuous hours of day and night glucose control; and 2) Camp studies planned for the summer of 2014 with randomization to either full closed-loop or sensor-augmented pump therapy over the duration of 6-7 day diabetes camps.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Stanford Investigators
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Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study
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The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp setting will allow us to obtain pilot efficacy data.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Stanford Investigators
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Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children
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The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. The study system includes a continuous glucose monitor (CGM) and an insulin pump. The CGM and pump work with a regular laptop computer. A The system works by (1) measuring the glucose levels under the skin with the CGM, (2) using a computer program on the laptop to predict whether a low blood sugar is likely to occur, and (3) turning off the insulin pump when the computer program predicts that a low blood sugar will occur.
We have tested the system in the home environment in individuals with type 1 diabetes age 15 years and older. We have found an indication that the system can decrease the frequency of hypoglycemia. We have not had any serious cases of high blood sugars or other problems. We are now ready to further test the system in the home environment in a younger age group to learn more about its ability to reduce overnight low blood sugar risk.
This study has several phases and will take about 3 months for a patient to complete.
* First, the patient will use the CGM and pump at home for up to 15 days with the help of a parent/guardian. This is done to determine if the patient meets our study criteria to proceed with the next phase of the study.
* If the patient is eligible to continue in the study, the patient will need to use the full study system for at least 5 nights at home with the help of a parent/guardian. This is done to make sure the patient and parent/guardian are able to use the system correctly. The patient may participate in starting and stopping the system at home, but the parent/guardian is responsible for making sure it is used as instructed.
* After that, the patient will be asked to use the study system each night for an additional 6 to 8 weeks. The parent/guardian will remain responsible for making sure the system is used as instructed.
The study will include about 90 individuals with type 1 diabetes at 3 clinical centers in the United States and Canada. First a study of children 8 to less than 15 years old will be done. Then, a study of children 3 to less than 8 years old will be conducted.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Stanford Investigators
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Duration of Infusion Set Function: Quick-Set Teflon Catheter Versus Sure-T Steel Infusion Set Catheter
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This is an open-label cross over study looking to compare the length of infusion set wear between a teflon catheter (Quick-Set) or a steel (Sure-T) catheter.
Stanford is currently not accepting patients for this trial.
For more information, please contact Parul Patel, 6507235791.
Lead Sponsor
Stanford Investigators
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Testing State of the Art Remote Glucose Monitoring at Diabetes Camp
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The incidence of low blood sugar and hypoglycemic seizures at diabetes camp has been reduced thanks to overnight blood glucose level testing. The timing of the overnight blood test is often arbitrary and it is unclear when the highest frequency of nocturnal hypoglycemic events at camp are occurring. It is also unclear what the most appropriate treatment for nocturnal hypoglycemia is: simple carbohydrates, or mini-glucagon.
In this study, we will use Continuous Glucose Monitors (CGMs) that will send subject data securely to a remote computer located in the medical cottage at camp throughout the night. Study staff will monitor the computer and will intervene on low blood sugar as it occurs in real time. On half of the nights, campers will receive mini-glucagon for low blood sugar, and on the rest, they will receive standard carbohydrate treatment.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Lead Sponsor
Stanford Investigators
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Outpatient Pump Shutoff Pilot Feasibility and Efficacy Study
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The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous glucose monitor, (2) using a computer program on a laptop to predict what will happen to the glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program predicts that low blood sugar will occur.
This study has several phases and will take about 3 months for a patient to complete. Patients will use the Medtronic CGM with the Enlite sensor at home for 10-15 days to be sure that they are able and willing to use this system and to determine if they meet the investigators study criteria to proceed with the next phase of the study. Patients will be provided teaching on how to use CGM data in real time. If a patient is not using a Medtronic CGM already, the patient will first use one at home for 10-15 days to be sure that he/she is able and willing to use it. If a patient is already using a Medtronic CGM, then his/her most recent 10-15 days of data will be used to find out if he/she is eligible. Those who need to complete the CGM run-in phase will have an extra office visit for training.
If eligible to continue in the study, patients will need to use the study system for 5 nights at home so that the investigators can make sure they are able to use it correctly. After that, patients will be asked to use the study system each night for an additional 6 to 8 weeks. If the system is active and predicts that a patient's blood sugar will become low, the insulin pump will shut off for up to 2 hours.
The study will include about 45 individuals at 3 clinical centers in the United States and Canada.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Stanford Investigators
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Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring
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The purpose of doing this study is to see if continuous glucose monitoring can help people with type 1 diabetes who are sometimes unable to feel if they have a low blood glucose reading. For this study we will be using the Navigator Continuous Glucose Monitor. We think that your body may not have enough of a certain hormone that usually helps people know when they are going low. If you can keep from going low, we think there will be enough of that hormone to help you recognize the symptoms of a low before it happens.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Lead Sponsor
Stanford Investigators
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Medtronic Minimed Overnight Closed-Loop System
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To test the function and safety of the Medtronic Overnight Closed Loop (OCL) System in a closely monitored 12 hour overnight inpatient study. Once the safety of the device has been validated we will move the study to an outpatient diabetes camp setting. The camp setting will allow us to obtain pilot efficacy and safety data in a "real-life" environment.
We plan to compare the subject control nights to the subject nights on the OCL system to assess the percent of sensor glucose readings in the target range of 70-150 mg/dl. Based on previous research, we anticipate that the use of the OCL system will contribute to a greater percentage of sensor glucose readings in the target range.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Stanford Investigators
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Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes
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The purpose of this study is to learn about the impact of continuous glucose monitoring (CGM) on families with newly diagnosed children with type 1 diabetes (T1D). The investigators hope to learn about how continuous glucose monitoring affects glycemic variables and diabetes-related distress.
Stanford is currently not accepting patients for this trial.
For more information, please contact Sarah Hanes, 650-736-6661.
Stanford Investigators
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Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing in Children and Young Adolescents
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Objective: to gain experience in children and younger adolescents with in-home use of an algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data
Study Design: randomized controlled trial, with randomization on a night level within subject Patient Population: Youth 6.0 - \<15 years old with type 1 diabetes treated with daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months who have HbA1c \< 10.0%.
Sample Size: 30 subjects
Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at enrollment, following CGM and system assessment run-in phases, at start of clinical trial phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use
Major Efficacy Outcomes:
* Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight.
* Secondary: time spent in hypoglycemia (\<70 mg/dl, 3.9 mmol/L) and time spent in hyperglycemia (\>180 mg/dl, 10.0 mmol/L) overnight.
Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and diabetic ketoacidosis
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Stanford Investigators
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Medtronic Treat to Range (TTR) Closed-Loop Control
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The purpose of this study is to evaluate a treat-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes.
Stanford is currently not accepting patients for this trial.
For more information, please contact Kari Benassi, RN, FNP, 650-736-8948.
Lead Sponsor
Stanford Investigators
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A Randomized Control Trial Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Blood Sugars.
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The purpose of this study is to determine if the use of Linjeta(tm) insulin when compared to Humalog will result in significantly lower episodes of hyperglycemia and hypoglycemia after a breakfast meal.
Stanford is currently not accepting patients for this trial.
For more information, please contact Parul Patel, 6507235791.
Lead Sponsor
Stanford Investigators
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Pilot Study to Evaluate a Method of Controlling High Blood Sugar in the Pediatric Intensive Care Unit
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Recent studies of adult intensive care unit (ICU) patients have shown significantly decreased morbidity and mortality when blood sugar concentrations are closely controlled. The safety and efficacy of this type of blood sugar management has not been studied in the pediatric ICU population. Based on the current pediatric literature data as well as our extensive retrospective study, blood sugar concentrations have a potentially profound role to play among PICU patients. In preparation for a multi-center randomized control trial, we propose a prospective feasibility study to evaluate the safety and effectiveness of using an insulin delivery algorithm to manage blood sugar in the PICU. Our hypothesis for this feasibility trial is that uniformly monitoring and controlling blood glucose with a Discrete-Closed-Loop(DCL) insulin delivery algorithm will be an effective, safe, and consistent means of delivering insulin to manage glucose in the pediatric intensive care unit.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Lead Sponsor
Stanford Investigators
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A Study to Evaluate a Multiple Model Probabilistic Predictive Controller (MMPPC) for Closed Loop Insulin Delivery
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You are invited to participate in a research study for the development of an artificial pancreas. An artificial pancreas uses a program which takes information from a continuous blood glucose monitor and uses that information to tell an insulin infusion pump how much insulin to deliver. The primary purpose of this study is to gain experience with insulin delivery algorithms or programs program (algorithm) provides the best regulation of glucose levels so that there are no severe low blood glucose reactions and blood glucose levels are generally between 70 to 180 mg/dl.
Stanford is currently not accepting patients for this trial.
For more information, please contact Paula Clinton, 6507362313.
Lead Sponsor
Stanford Investigators
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Evaluation of Extended Infusion Set Wear Using Medtronic Extended Wear Sof-set Infusion Set
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This is a blinded cross-over study to see if extended wear insulin infusion sets can prolong insulin infusion set wear up to 7 days in adults with Type 1 Diabetes.
Stanford is currently not accepting patients for this trial.
For more information, please contact Bertha deLanda, BA, 650-721-6357.
Lead Sponsor
Stanford Investigators
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USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D
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This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type 1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia.
Stanford is currently not accepting patients for this trial.
For more information, please contact Bruce Buckingham, MD, 650-723-5791.
Stanford Investigators
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Fault Detection, Zone MPC and DiAs System in T1D
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This is a randomized crossover study testing the efficacy of the Fault Detection algorithms using the Zone MPC algorithm and DiAs artificial pancreas platform in adult patients with type 1 diabetes. The trial will last for 6 weeks for each individual subject, with three weeks using the AP algorithm and three weeks using sensor augmented pump in a randomized order
Stanford is currently not accepting patients for this trial.
For more information, please contact Trang Ly, MBBS PhD, 650.215.0732.
Stanford Investigators
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An Outpatient Pump Shutoff Pilot Feasibility and Safety Study
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The purpose of this study is to evaluate an overnight system that will turn off the insulin pump automatically if the system predicts that a low blood sugar is likely. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous glucose monitor, (2) using a computer program on a laptop to predict what will happen to the glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program predicts that low blood sugar will occur. We have tested this system overnight in the hospital and are ready to test the system in the home environment to learn more about how well it will work and to make sure that the blood sugar does not go too high when the pump shuts off.
This study has several phases and will take about a month or a little more for a patient to complete. Patients will use the study system for about 5 days at home to show that the patient is able to use it correctly. After that, the patient will be asked to use the study system each night for an additional 3-4 weeks. During this time, the system will be active for two-thirds of the nights and not active for one-third of the nights. When the system is active and predicts that your blood sugar will become low, the insulin pump will shut off for up to 2 hours.
The study will include 2 clinical centers in the United States.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Stanford Investigators
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International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol
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The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.
Stanford is currently not accepting patients for this trial.
For more information, please contact Bruce Buckingham, MD, 650-723-5791.
Stanford Investigators
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Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes
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This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate that the closed loop algorithm is safe as part of the overall system, and to assess the PLGM feature in 7-13 years old subjects.
Stanford is currently not accepting patients for this trial.
For more information, please contact Suzette Reuschel-Virgilio, 650-725-3950.
Stanford Investigators
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An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas
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This is an open-label, non-randomized, pilot study to determine the safety and feasibility of the insulin-only bionic pancreas.
Stanford is currently not accepting patients for this trial.
For more information, please contact Paula Clinton, RD, CDE, 650-736-2313.
Stanford Investigators
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Hyaluronidase Effect on Infusion Set Life
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This research study examines the effect of hyaluronidase on the length of time of insulin infusion set wear. The aim of the study is to improve the length of time that an infusion set can be worn by infusing hyaluronidase directly into the insulin infusion site.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Lead Sponsor
Stanford Investigators
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Insulet Artificial Pancreas Early Feasibility Study
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The purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.
Stanford is currently not accepting patients for this trial.
For more information, please contact Bruce Buckingham, MD, .
Stanford Investigators
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Fault Detection, Zone MPC and DiAs System in T1D
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This is a randomized crossover study testing the efficacy of the Fault Detection algorithms using the Zone MPC algorithm and DiAs artificial pancreas platform in adult patients with type 1 diabetes. The trial will last for 6 weeks for each individual subject, with three weeks using the AP algorithm and three weeks using sensor augmented pump in a randomized order
Stanford is currently not accepting patients for this trial.
For more information, please contact Trang Ly, MBBS PHD, 650.215.0732.
Stanford Investigators
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Development of Algorithms for a Hypoglycemic Prevention Alarm: Closed Loop Study
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This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being conducted at Stanford University Medical Center and the University of Colorado Barbara Davis Center. It is paid for by the Juvenile Diabetes Research Foundation.
The purpose of doing this research study is to understand the best way to stop an insulin infusion pump from delivering insulin to prevent a subject from having hypoglycemia. Nocturnal hypoglycemia is a common problem with type 1 diabetes. This is a pilot study to evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor communicating wirelessly with a bedside computer running an algorithm that temporarily suspends insulin delivery when hypoglycemia is predicted in a home setting.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Lead Sponsor
Stanford Investigators
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Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller
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The primary objective of this study is to evaluate the safety and efficacy of the Medtronic hybrid closed-loop (HCL) system utilizing the proportional-integral-derivative algorithm with insulin feedback (PID-IFB) optimized to function in a hybrid mode with closed-loop control operating during the day and night.
Stanford is currently not accepting patients for this trial.
For more information, please contact Bruce Buckingham, MD, (650) 723-5791.
Lead Sponsor
Stanford Investigators
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Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms
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Objective: to gain experience with in-home use of a modified algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data.
Study Design: randomized controlled trial, with randomization on a night level within subject.
Major Eligibility Criteria: clinical diagnosis of type 1 diabetes, daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months; 15.0 to \<46.0 years of age; HbA1c \< 10.0%; no DKA in last 6 months; no hypoglycemic seizure or loss of consciousness in last 6 months; Living with a significant other or family member ("companion") committed to participating in all study activities, and being present and available to provide assistance when the system is being used at night.
Sample Size: 30 subjects.
Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at enrollment, following CGM and system assessment run-in phases, at start of clinical trial phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use.
Major Efficacy Outcomes:
* Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight.
* Secondary: time spent in hypoglycemia (≤70 mg/dl, 3.9 mmol/L) and time spent in hyperglycemia (\>180 mg/dl, 10.0 mmol/L) overnight.
Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and diabetic ketoacidosis.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Stanford Investigators
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Assessment of an Automatic Closed-loop Insulin Delivery System
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The overall aim of this research proposal is to determine the safety, feasibility and efficacy of an automatic closed-loop insulin delivery system.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Lead Sponsor
Stanford Investigators
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Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy
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This is a pilot outpatient study conducted at Stanford to obtain preliminary data on how Fiasp® works in a closed-loop system and to determine if any changes need to be made to the 670G pump to optimize the use of Fiasp®.
Stanford is currently not accepting patients for this trial.
For more information, please contact Liana Hsu, BS, 650-725-3939.
Lead Sponsor
Stanford Investigators
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