Outpatient Pump Shutoff Pilot Feasibility and Efficacy Study
Outpatient Pump Shutoff Pilot Feasibility and Efficacy Study
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.
Patients who are eligible for the clinical trial initially will use a Medtronic Continuous
 Glucose Monitor (CGM) at home to verify that the subject is able to use the CGM and insert
 sensors. Subjects already using a Medtronic CGM will skip this phase, provided that the
 eligibility criteria for CGM use and the study are met.

 Patients who meet criteria for sensor use and the study will then use the closed-loop system
 at home for 5 days to demonstrate their ability to use the system and submit study data to
 the Coordinating Center.

 Patients who successfully demonstrate their ability to use the system at home as described
 above will be eligible for the randomized trial phase. This phase consists of use of the full
 system as an outpatient for approximately 42 nights:

 -  Each night the blood glucose level will be checked with the study home blood glucose
 (BG) meter and used to perform a calibration of the CGM. This calibration must occur no
 more than 90 minutes prior to activation of the system. NOTE: Patients will be
 instructed to calibrate the CGM per manufacturer guidelines.

 -  Then the system will be activated, linking the CGM and insulin pump to the computer at
 the bedside.

 -  A randomization schedule on the laptop will be used to determine whether the 'pump shut
 off' application will be active that night or not.

 -  Patients will be blinded as to whether the pump shut off is active when a session is
 initiated each night.

 -  There will not be an alarm if the pump shuts off. The CGM alarm will be set to 60 mg/dL
 (3.3 mmol/L). When a CGM alarm occurs, the patient will be asked to measure the blood
 glucose with a BG meter, if he/she is aware of the alarm.

 -  The time period for outcome assessment each night will be from the time the system is
 activated until it is turned off in the morning

 -  Pump shut off, when it occurs, will be for up to 2 hours. Multiple instances of pump
 suspension can occur if there are recurrent predictions of hypoglycemia during the
 night.

 -  Patients will be asked to check blood glucose with the study BG meter, blood ketones
 with the study ketone meter, and urine ketones with a ketone strip each morning prior to
 breakfast and enter the results on the study laptop. The patient will be instructed to
 contact the study physician if the blood glucose or ketone readings are out of an
 expected range. Patients will be contacted if these morning safety values are not
 reported as required or are out of range.

 -  Patients will be asked to record all overnight carbohydrate intake on the study laptop.

 -  Patients will be asked to perform periodic data uploads using the study laptop.
 Monitoring processes will ensure that the patient is contacted if these uploads do not
 occur as required, or if review of an upload reveals any extreme, prolonged episodes of
 low or high blood glucose readings, or elevated morning blood glucose, blood ketone, or
 urine ketone values.

 Upon completion of the study, patients as well as study clinicians will be asked to complete
 a questionnaire regarding use of the study system.

 There will be one follow-up visit after 21 days in the clinical trial and a second follow-up
 visit after the completion of 42 nights of successful study system use. A successful night of
 study system use is defined as use of the system for at least four hours. Phone contacts with
 the patients will be made once a week.
Inclusion Criteria:

 -  Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one
 year and an insulin infusion pump for at least 6 months

 -  Age >/= 15.0 - 45 years

 -  HbA1c </= 8.0%

 -  Availability of internet access for periodic upload of study data

 Exclusion Criteria:

 -  Diabetic ketoacidosis in the past 3 months

 -  Hypoglycemic seizure or loss of consciousness in the past 6 months

 -  History of seizure disorder (except for hypoglycemic seizure)

 -  History of any heart disease including coronary artery disease, heart failure, or
 arrhythmiasCoronary artery disease or heart failure

 -  Cystic fibrosis

 -  Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which
 in the judgment of the investigator would be a contraindication to participation in
 the study.

 -  History of ongoing renal disease (other than microalbuminuria), or liver disease
 (Creatinine > 1.5 mg/dL (0.08 mmol/L))

 -  Medical or psychiatric condition that in the judgment of the investigator might
 interfere with the completion of the protocol such as:

 -  Inpatient psychiatric treatment in the past 6 months

 -  Uncontrolled adrenal disorder

 -  Abuse of alcohol

 -  Pregnancy

 -  Liver disease as defined by an ALT greater than 3 times the upper limit of normal