Protocol Director: / Bruce Buckingham, M.D. eP 36142
Protocol Title: / Evaluation of Extended Insulin Infusion Set Wear Using the Medtronic Extended Wear Quick-set Infusion Set. Part 2: Extended Wear Safety and Efficacy Pilot Study
Are you participating in any other research studies? _____ Yes _____No
PURPOSE OF RESEARCH
You are invited to participate in a research study of an investigational device.This study will compare a modified infusion set (investigational device) that contains a small dose of a drug called Heparin with the commercially available Medtronic Quick-set (control). We hope to learn if Heparin can extend infusion set wear up to 7 days when compared to the control. This is a “blinded” study which means neither you nor the research team treating you will know which infusion set you are wearing. The modified infusion set will look the same as the Medtronic Quick-set. The infusion sets will be labelled “A” or “B”. During the study you will alternate between wearing Set A and Set B every week. You will wear each set for up to 7 days or until an infusion set failure is detected.
In this study we will refer to the infusion sets as “study devices” or “investigational devices”. The term “investigational” means that they have not yet been approved by the FDA (Food and Drug Administration) and can only be used in this study. Heparin is a drug that has been approved by the FDA to use as an anticoagulant (blood thinner) and to treat patients with a high risk of developing blood clots. However, in this study, the way we use Heparin is considered to be a new and different use of the drug since it has not been approved for use in infusion sets.
This research study is looking for 20 subjects with Type 1 Diabetes. The study will only be conducted at Stanford University.
You were selected as a possible participant in this study because you are between 18 and 55 years old, have been diagnosed with Type 1 Diabetes, and have been using an insulin pump for at least 12 months.
VOLUNTARY PARTICIPATION
Yourparticipation in this study is entirely voluntary. Your decision not to participate will not have any negative effect on you or your medical care. You can decide to participate now, but withdraw your consent later and stop being in the study without any loss of benefits or medical care to which you are entitled.
If you decide to terminate your participation in this study, you should notify Dr. Bruce Buckingham, MD at 650-725-6549.
DURATION OF STUDY INVOLVEMENT
This research study is expected to take approximately 5 weeks and will include 6 visits that will be scheduled about 1 week apart. Each visit will take about 2 hours.
PROCEDURES
If you choose to participate, the Protocol Director and his research study staff will have you sign this consent form prior to performing any of the study procedures described below. All visits should be considered part of the research and not part of your clinical care.
Visit 1: Consent, lab tests and exam
Informed consent process: First the study will be explained to you, and you will be given time to read this informed consent and ask any questions about the study.
If you agree and sign this form, we will perform some laboratory tests and do a brief physical exam to see if you qualify for the study.
Laboratory tests: You will have blood drawn (approximately 4tablespoons per visit). If you are a woman of childbearing age, a urine test to check for pregnancy will also be administered. The blood used for this study will be consumed in the testing and will not be used for future tests or stored for future research.
History and physical exam: including vital signs, height, weight, and examination of skin where infusion sets and sensors will be inserted.
If you choose to participate, the Protocol Director and his research study staff will have you sign this consent form prior to performing any of the study procedures described below. All visits should be considered part of the research and not part of your clinical care. The protocol director will review the information collected at this visit and the results of your laboratory tests to determine if you qualify for the study. If you qualify for the study, you will be scheduled to return for Visit 2.
Visit 2: Week 1 of in-home infusion set wear
You will return for to the research clinic to begin use of the investigational device. At the beginning of the visit we will collect a blood sample for clinical laboratory testing.
The research staff will give you a Contour Next Link glucose meter, Precision Ketone meter, and Medtronic Enlite Sensor. You will be instructed to use the provided meters to test your blood glucose at least 4 times a day (before meals and bedtime) and to test for ketones if your glucose is greater than 250 mg/dL.
Your current insulin pump will be downloaded and the pump settings will be transferred to a 530G insulin pump with the threshold suspend feature disabled. If you are currently using a 530G insulin pump, you will continue using your personal pump for this study however the threshold suspend feature will be disabled. If you are not using a Medtronic insulin pump the research staff will train you to use the pump and make sure that you feel comfortable using it before you go home.
A Medtronic Enlite glucose sensor will be inserted under your skin (similar to how you insert your infusion sets). The sensor measures glucose levels under your skin every few minutes and sends information to the insulin pump. If you have never used an Enlite sensor, the research staff will train you and provide you with instruction on proper use. You should always do a fingerstick blood test to check your glucose before making any treatment decisions.
You will be randomly assigned to wear either Set A or Set B for the first week of the study. You will then alternate between wearing Set A or Set B every week. If you are assigned Set A the first week, you will wear Set B the next week, then Set A again the following week, and so forth. Alternately, if you are assigned Set A the first week, you will wear Set B the next week. In this study we plan to have 10 participants start with Set A and 10 participants start with Set B. You have a 50% chance of being assigned to either group.
You will be instructed to insert the investigational device (infusion set) into an area without lipohypertrophy (fatty lumps on the surface of the skin that are a fairly common side effect of insulin injections). Your insulin reservoir will be filled with Novolog*insulin and you will start using the Medtronic 530G pump.
*All subjects are required to use Novolog insulin for the duration of the study. The research staff will provide you with Novolog at no cost to you.
The research staff will make sure that you understand all study procedures and feel comfortable using all of the devices before you leave the clinic.
At-home procedures:
Blood glucose monitoring and Ketone testing:use the Contour Next Link meter to check blood glucose meter at least 4 times each day (before meals and at bedtime). Check blood ketones with the Precision if the blood glucose meter reading is greater than 250 mg/dL.
Sensor Calibration: Calibrate the Enlite glucose sensor before breakfast and before dinner each day when there are no rate of change arrows. You should also calibrate if the Enlite glucose sensor if it is showing more than a 20% error when compared to your Contour Next blood glucose reading.
Replacement of Enlite Glucose Sensor: If the Enlite glucose sensor stops functioning during the study, you need to insert a new sensor which will be provided. You should be wearing an Enlite sensor all the time that you are using study infusion sets.
Infusion set failure: Replace your infusion set when any of the conditions listed below occur:
- Your ketone level is greater than 0.6 mmol/L,
- You see evidence of infection at the infusion site
- The blood glucose (meter) does not decrease by at least 50 mg/dL within 1 hour of a correction bolus to treat an unexplained elevation of your blood glucose greater than 250 mg/dL (i.e. you know the elevated glucose was not due to a meal or missed insulin dose).
- There is an occlusion alarm on your pump
Bruising, redness, swelling or pain:
- You should contact the research staff if you see any changes were the investigational device (infusion set) is inserted or if you see any unusual unexplained bruising in other areas of your skin.
- You take a picture of any changes you see and send it to the research staff.
- You should immediately remove the infusion set if you experience any pain or discomfort at the infusion site.
You will wear the investigational device (infusion set) for up to 7 days or until an infusion set failure is detected.
Study log at home: At home we will ask you to examine the infusion set site and Enlite glucose sensor site on a daily basis. You should inspect the sites in an area with sufficient lighting. We will email you a daily questionnaire to complete to help you assess both sites and record required information. You willmeasure and record any redness, swelling, and bruising in mm with a ruler that will be provided to you. You should call one of the research staff if you note any unusual redness, swelling or bruising. Please take a picture of any unusual changes. Never hesitate to contact the research staff if you are uncertain and need any guidance.
Remember to record the data, time and reason for removing the infusion set.
Once you remove the investigation infusion set, you will wear a commercially available Medtronic infusion set until your next visit.
Visit 3: week 2 of in-home infusion set wear
You will return 7 days after your previous visit. The infusion set and sensor insertion sites will be examined. Photographs of the sites will be taken if there are any significant changes. Your insulin pump, blood glucose meter, and ketone meter data will be downloaded. You will then get a new infusion set inserted. We will collect a blood sample for clinical laboratory tests.
Set B will be inserted if you wore Set A the first week.
Set A will be inserted if you wore Set B the first week.
Visit 4: week 3 of in-home infusion set wear
You will return 7 days after your previous visit. The infusion set and sensor insertion sites will be examined. Photographs of the sites will be taken if there are any significant changes. Your insulin pump, blood glucose meter, and ketone meter data will be downloaded. You will then get a new infusion set inserted. We will collect a blood sample for clinical laboratory tests.
Set A will be inserted if you wore Set B the previous week.
Set B will be inserted if you wore Set A the previous week.
Visit 5: week 4 of in-home infusion set wear
You will return 7 days after your previous visit. The infusion set and sensor insertion sites will be examined. Photographs of the sites will be taken if there are any significant changes. Your insulin pump, blood glucose meter, and ketone meter data will be downloaded. You will then get a new infusion set inserted. We will collect a blood sample for clinical laboratory tests.
Set B will be inserted for the final week if you wore Set A the previous week.
Set A will be inserted for the final week if you wore Set B the previous week.
Visit 6:Clinic return and final visit
Seven days after the fourth infusion set was inserted, you will have your final study visit at a clinic. The infusion set and sensor insertion sites will be examined. Photographs of the sites will be taken if there are any significant changes. We will collect a blood sample for clinical laboratory tests.
This sixth visit will conclude your participation in the study. All devices provided by the study will be returned which includes: infusion sets, glucose sensors, glucose meter, ketone meter, study provided insulin pump, and study provided transmitters.
Women of Childbearing Potential
If you are a woman who is able to become pregnant, it is expected that you will use an effective method of birth control to prevent exposing a fetus to a potentially dangerous agent with unknown risk. If you are pregnant or currently breast feeding, you may not participate in this study. You understand that if you are pregnant, if you become pregnant, or if you are breast-feeding during this study, you or your child may be exposed to an unknown risk
To confirm to the extent medically possible that you are not pregnant, you agreeto have a urine pregnancy test done before beginning this research study orto begin the study after the onset of your next menstrual period.
You must agree to avoid sexual intercourse or use a birth control method judged to be effective by the investigator and which will not interfere with the proposed investigation. You must accept the risk that pregnancy could still result despite the responsible use of reliable method of birth control. You agree to notify the investigator as soon as possible of any failure of proper use of your birth control method, or if you become pregnant, either of which may result in your being withdrawn from the study.
The results of the study of your samples from this project will be used for research purposes only, and you will not be told the results of the tests. Some of your samples will be sent outside of Stanford for analysis.
PARTICIPANTRESPONSIBILITIES
As a participant, your responsibilities include:
- Follow the instructions of the Protocol Director andstudy staff.
- Use the devices and record the information we request.
- Keep your study appointments. If it is necessary to miss an appointment, please contact the Protocol Director or research study staff to reschedule as soon as you know you will miss the appointment.
- Tell the Protocol Director or research study staff about any side effects, doctor visits, or hospitalizations that you may have.
- Tell the Protocol Director or research staff if you believe you might be pregnant or gotten your partner pregnant.
- Keep the study device in a safe place, away from children and for your use only.
- Keep your diaries and logs as instructed.
- Ask questions as you think of them.
- Tell the Protocol Director or research staff if you change your mind about staying in the study.
WITHDRAWAL FROM STUDY
If you first agree to participate and then you change your mind, you are free to withdraw your consent and discontinue your participation at any time. Your decision will not affect your ability to receive medical care for your disease and you will not lose any benefits to which you would otherwise be entitled.
If you decide to withdraw your consent to participate in this study, you should notify Dr. Bruce Buckingham at 650-725-6549.
If you withdraw from the study, or the use of the study device is stopped for any reason, you must return all study-related supplies, including the study device and components.
The Protocol Director may also withdraw you from the studywithout your consent for one or more of the following reasons:
- Failure to follow the instructions of the Protocol Director and study staff.
- The Protocol Director decides that continuing your participation could be harmful to you.
- Pregnancy
- You need treatment not allowed in the study.
- The study is cancelled.
- Other administrative reasons.
- Unanticipated circumstances.
POSSIBLE RISKS,DISCOMFORTS, AND INCONVENIENCES
There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. You should talk with the Protocol Director if you have any questions.
Risk of Heparin Use
Heparin is FDA-approved medication and is derived from porcine intestinal mucosa, standardized for anticoagulant activity. In this study very small doses will be given over multiple days.
The doses used in this study will have a local effect and could result in local bruising. In our previous study of one Heparin dose level in infusion sets, some subjects noted significant bruising at the insertion site. This study has been modified to use a dose of Heparin that was tolerated well by subjects in our dose finding study. You should contact the research staff if you see any unusual bruising.