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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension: An Outpatient Pilot Feasibility and Efficacy Study|
- Comparison of intervention nights to control nights in which hypoglycemia occurred [ Time Frame: 42 nights ] [ Designated as safety issue: No ]Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤70 mg/dL. The percentage of hypoglycemic nights will be tabulated separately with versus without the closed-loop control system in use. A repeated measures logistic regression model will be used to compare intervention versus control nights accounting for correlated data from the same subject and adjusting for the baseline (bedtime) sensor glucose.
- Percentage of sensor glucose values 71 to 180 mg/dL [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
- Proportion of nights with a sensor glucose value </= 60 mg/dL [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
- Proportion of nights with a sensor glucose value </= 50 mg/dL [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
- For nights when sensor glucose </= 70 mg/dL, tabulation whether blood glucose measured with study blood glucose meter [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
- Mean home glucose meter morning glucose [ Time Frame: 42 nights ] [ Designated as safety issue: Yes ]
- Morning glucose measured with home glucose meter >250 mg/dL [ Time Frame: 42 nights ] [ Designated as safety issue: Yes ]
- Morning blood ketones >1.0 mmol/L [ Time Frame: 42 nights ] [ Designated as safety issue: Yes ]
- Morning urine ketones >/= small amount [ Time Frame: 42 nights ] [ Designated as safety issue: Yes ]
- Mean sensor glucose [ Time Frame: 42 nights ] [ Designated as safety issue: No ]Mean sensor glucose will be assessed over 24 hours and for 4 hours post system deactivation
- Area under the curve for sensor glucose <70mg/dL, 60 mg/dL, and 50 mg/dL [ Time Frame: 42 nights ] [ Designated as safety issue: No ]Area under the curve will be assessed over 24 hours and over the first 4 hours following system deactivation
- Area under the curve sensor glucose >180 mg/dL and 240 mg/dL [ Time Frame: 42 nights ] [ Designated as safety issue: No ]Area under the curve will be assessed over 24 hours and over the first 4 hours following system deactivation
- Percent of nights with sensor glucose >250 mg/dL [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
- Morning ketones >0.6 mmol/L [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
- Episodes of DKA [ Time Frame: 42 nights ] [ Designated as safety issue: Yes ]
- Episodes of severe hypoglycemia [ Time Frame: 42 nights ] [ Designated as safety issue: Yes ]
- Change in Hemoglobin A1c [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Pump suspension algorithm
The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Device: Pump suspension
The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.
No Intervention: Standard of Care
The control algorithm will run passively and not recommend control the patient's pump.
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.
|United States, California|
|Stanford, California, United States, 94305|
|United States, Colorado|
|Barbara Davis Center for Childhood Diabetes|
|Aurora, Colorado, United States, 80045|
|St. Joseph's Health Care|
|London, Ontario, Canada, N6A4V2|
|Principal Investigator:||Roy Beck, MD, Ph.D.||Jaeb Center for Health Research|
|Study Chair:||Bruce Buckingham, MD||Stanford University|
|Study Director:||John Lum, MS||Jaeb Center for Health Research|