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Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes
Not Recruiting
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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
Recruiting
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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 Investigators
View full details
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The International Diabetes Closed Loop (iDCL) Trial: Protocol 4
Not Recruiting
More
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
View full details
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Omnipod Horizon™ Automated Glucose Control System Preschool Cohort
Not Recruiting
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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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Prepivotal Omnipod Horizon™ Automated Glucose Control System
Not Recruiting
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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
View full details
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Pivotal Omnipod Horizon™ Automated Glucose Control System
Not Recruiting
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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
View full details
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Real-time Reminders To Decrease Late or Missed Meal Boluses
Not Recruiting
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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
View full details
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Longevity of Multi-Slitted Catheter With Lantern Technology
Not Recruiting
More
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
View full details
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Full Day and Night Closed-Loop With DiAs Platform
Not Recruiting
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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
View full details
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Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study
Not Recruiting
More
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
View full details
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Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children
Not Recruiting
More
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
Not Recruiting
More
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
View full details
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Testing State of the Art Remote Glucose Monitoring at Diabetes Camp
Not Recruiting
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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
View full details
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Outpatient Pump Shutoff Pilot Feasibility and Efficacy Study
Not Recruiting
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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
View full details
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Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring
Not Recruiting
More
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
View full details
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Medtronic Minimed Overnight Closed-Loop System
Not Recruiting
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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
View full details
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Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes
Recruiting
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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 Investigators
View full details
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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
Not Recruiting
More
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
View full details
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Medtronic Treat to Range (TTR) Closed-Loop Control
Not Recruiting
More
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
View full details
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A Randomized Control Trial Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Blood Sugars.
Not Recruiting
More
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
View full details
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Pilot Study to Evaluate a Method of Controlling High Blood Sugar in the Pediatric Intensive Care Unit
Not Recruiting
More
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
View full details
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A Study to Evaluate a Multiple Model Probabilistic Predictive Controller (MMPPC) for Closed Loop Insulin Delivery
Not Recruiting
More
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
View full details
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Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
Not Recruiting
More
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
View full details
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Evaluation of Extended Infusion Set Wear Using Medtronic Extended Wear Sof-set Infusion Set
Not Recruiting
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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
View full details
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USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D
Not Recruiting
More
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
View full details
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Fault Detection, Zone MPC and DiAs System in T1D
Not Recruiting
More
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
View full details
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An Outpatient Pump Shutoff Pilot Feasibility and Safety Study
Not Recruiting
More
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
View full details
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International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol
Not Recruiting
More
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
View full details
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Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes
Recruiting
More
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 Investigators
View full details
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An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas
Not Recruiting
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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
View full details
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Hyaluronidase Effect on Infusion Set Life
Not Recruiting
More
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
View full details
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Insulet Artificial Pancreas Early Feasibility Study
Not Recruiting
More
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
View full details
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Fault Detection, Zone MPC and DiAs System in T1D
Not Recruiting
More
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
View full details
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Development of Algorithms for a Hypoglycemic Prevention Alarm: Closed Loop Study
Not Recruiting
More
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
View full details
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Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller
Not Recruiting
More
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
View full details
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Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms
Not Recruiting
More
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
View full details
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Assessment of an Automatic Closed-loop Insulin Delivery System
Not Recruiting
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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
View full details
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Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy
Not Recruiting
More
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
View full details
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The Insulin-Only Bionic Pancreas Pivotal Trial
Not Recruiting
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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 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 blood glucose
measurements instead of 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
View full details
