Medtronic Minimed Overnight Closed-Loop System
|First Received Date ICMJE||June 16, 2013|
|Last Updated Date||March 5, 2015|
|Start Date ICMJE||June 2013|
|Primary Completion Date||July 2013 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Target sensor glucose 70-150 mg/dl [ Time Frame: Approximately 12 hours ] [ Designated as safety issue: Yes ]
Compared to control nights, the percent of sensor glucose readings in the target range of 70-150 mg/dl.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01881009 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Percentage of time CGM glucose readings are <70 mg/dl and > 180 mg/dl [ Time Frame: Approximately 12 hours ] [ Designated as safety issue: Yes ]
Secondary measures of glucose efficacy comparing treatment to control nights:
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Medtronic Minimed Overnight Closed-Loop System|
|Official Title ICMJE||Nocturnal Closed-Loop Control Using An ePID (Enhanced Proportional Integral Derivative) Algorithm On An Android Platform With Remote Monitoring In A Closely Monitored Camp Setting: The OCL Camp Study|
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.
The steps are the same for the inpatient and camp studies, except that during the inpatient study subjects will have an IV inserted and blood samples will be obtained every 1/2 hour overnight. They will also have 20-30 minutes of activity in the afternoon and evening. After 16 subjects have entered the inpatient study, their data will be sent to the DSMB (Data Safety Monitoring Board) for review. If the studies show that these studies have met our predefined safety criteria, and the DSMB approves, we will then conduct our outpatient studies.
Subjects who are eligible for the study (camp or inpatient hospital) will be contacted by phone and email, the study will be explained to them, and after written consent is obtained, they will be enrolled in the study. They will be mailed a Bayer Next meter, control solutions, and glucose test strips.
Step 2: The will perform quality control test on the meter using the control solutions, and email these results to the study coordinator. For the week prior to the research center admission or camp they will be asked to use the Bayer meter to obtain two fasting glucose levels 20 minutes apart. They will be called by the study coordinator 3-5 days prior to admission to review these blood glucose testing requirements with the family. Subjects who have at least 3 days of data will be eligible for study participation.
Step 3: On arrival to the hospital, camp or bus stop subjects will bring an original informed consent signed by both parents and/or guardians if less than 18 years old. This generally occurs between 10 AM and noon at the camps, and we will have them arrive before lunch to the research center.
Step 4: The will have lunch, and within the first 3 hours after lunch (or within 3 hours of arrival to camp or the research center) they will have a history, limited physical exam and an A1c level and pregnancy test if female.
They will be assigned a unique 5 digit identifier: The first digit is for the camp session; the next two digits are for their cabin number; and the last two digits are for their subject ID (identification). Subject 30804 would be in camp session 3, assigned to cabin 8, and subject 4. All subjects enrolled will be assigned a subject ID which progressively increases across all camp sessions, i.e. during the summer there will be only one subject #4.
Step 5: Their Medtronic pump (from home) and Bayer meter will be uploaded. Two Enlite sensor will be used during the inpatient study. Only one Enlite sensor will be used during the camp phase of the study. All sensors will be inserted before 3pm and subjects will be given a study pump, and all their pump settings will be transferred to the study Revel 2.0 Medtronic Insulin Pump. They will receive training on the study pump and Enlite sensors. The CGM training will be done as a group session and will consist of the standard teaching which we developed for the JDRF (Juvenile Diabetes Research Foundation) randomized clinical trial. Insulin doses are only given by camp medical staff (including all correction doses), we will not use predictive alarms. Alarm thresholds will be set for 70 and 250 mg/dl during the day and on control nights. When the CLP is active at night, the local alarms on the Revel 2.0 pump will be turned off. There will be no rate of change alarms. There active insulin time will be set to 6 hours. This will probably be different from their usual setting, and this will be explained to that this setting is for safety purposes during this study. The bolus wizard feature of the pump will be turned on and used for all insulin doses. They may use the type of meal boluses they would routinely use for meals at home (standard and/or dual wave or square wave boluses).
Step 6: Data from their pump and meter download will be used to initialize the CLP. These initialization parameters will be entered into the Android phone assigned to them (which will remain with study staff). Their name will taped onto the phone, their study pump, home pump and meter using a labeler. The date and time will be entered into each device so they are all times are synchronized to the nearest minute.
Step 7: At camp they will be randomized by cabins, so that an equal number of campers will be assigned to have active closed-loop control on the first night or be in the control arm on the first night. Thereafter they will be assigned to the alternate arm of the study every other night.
Step 8: The Enlite sensor(s) will be calibrated 2 hours after insertion, before dinner and at 9 PM if there are no rate of change arrows at these times on the first day. Thereafter calibration values will be entered before meals and before the 9 PM snack if there are no rate of change arrows. These finger sticks are done under supervision of a counselor who makes sure that their hands are either washed or the finger is cleaned with alcohol and allowed to dry before the finger prick.
Step 9: At camp there will be evening activities after dinner, which can range from "capture-the-flag", scavenger hunts, dances, campfires, and other activities. During the inpatient hospital stay we will have some activity after dinner between 7-8 PM where subjects will wear a heart rate monitor with the goal of achieving an elevated heart rate which varies between 100 to 140 bpm for 20 - 30 minutes. This may be accomplished using an exercise treadmill or bicycle, or other aerobic activities (jumping jacks, stair climbing, brief sprints, etc.). The goal is to have some evening activities that mimic some of the variable activities that occur at camp, so that they are not sedentary after dinner.
Step 11: On arrival to their cabins after evening activities those assigned to closed-loop control will have their CLP systems activated. In the hospital this will begin at 9 PM.
Step 12: The CLP (Closed Loop Platform, Android phone) will establish communication with the intranet at camp and remote monitoring will be confirmed by viewing data on a iPAD connected to the camp intranet. In the hospital CLP will establish communication with the hospital intranet service, and remote monitoring will be confirmed on a computer outside the patients room and on an iPAD.
Step 14: Patient management decisions based on meter glucose readings (and possible ketone readings during the study).
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Device: ePID Algorithm on an Android Platform with Remote Monitoring
Medtronic Overnight Closed-Loop System: Revel insulin pump, Enlite sensor, Minimed transmitter, ePID algorithm on an Android platform with remote monitoring.
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||July 2013|
|Primary Completion Date||July 2013 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
To be eligible for the study, a subject must meet the following criteria:
The presence of any of the following is an exclusion for the study:
|Ages||10 Years to 35 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01881009|
|Other Study ID Numbers ICMJE||G130115|
|Has Data Monitoring Committee||Yes|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Bruce A. Buckingham, Stanford University|
|Study Sponsor ICMJE||Bruce A. Buckingham|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Stanford University|
|Verification Date||March 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP