As you know, November is diabetes awareness month. I was inspired by all the experiences that other people with type 1 were sharing so I looked up research studies (https://www.jdrf.org/impact/research/clinical-trials/). I found several studies happening close to me and reached out to the contacts that were listed. I sent an email to Study 1 and they replied that they have completed enrollment for that study but asked if they could pass my info to another study. I said yes! So I get an email from Study 2 that they are working with sensors for Dexcom but the dates didn't line up with my schedule. I had also emailed Study 3 which was doing a study with other Medtronic sensors. The dates matched up with my schedule so I said why not! Two days before I was scheduled to start the study I got a call that they were having supply chain issues (I mean….who isn’t) and the sensors weren't there yet so they needed to postpone till the beginning of the year.
On the 6th they reached out to me about Study 4. They had a person drop out last minute and wanted to know if I could or was interested in participating in a study with Libre sensors. The first appointment would be on the 10th and a clinic day on the 13th. I said yes! So I went into the office on the 8th for an initial screening to make sure that I fit the criteria.
This study is being sponsored by Abbott and the primary purpose is to see the “Effect of Ascorbic Acid on Accuracy of the FreeStyle Libre Flash Glucose Monitoring System”. Ascorbic Acid is Vitamin C. I did ask ‘Why Vitamin C?’ because I know there are some drugs that can affect readings of CGM’s and they told me ‘well that is why we are studying it, to see if it does affect the readings’. I have used the Libre system before and had a great experience with it. The only downside was that it wasn’t continuous and wouldn’t alert me until I physically scanned the sensor. I also upgraded my pump and wanted the Control IQ from Tandem/Dexcom.
The study is made up of 3 visits.
- Screening visit - They took my demographics, medical history, explained the study, answered questions, and tested my hemoglobin level.
*Something they told me (and I didn’t know) was that if you are wanting to participate in sensor/device studies you can not give blood regularly or within 30 days (for this study). She explained that she has seen some studies say that you can’t give blood in the last 120 days.
**This then led to a conversation about giving blood. I was always told that as a T1D I can’t give blood or shouldn’t but she said that the recommendations changed. Now, as long as your numbers are controlled and stable and you have not used pig or cow insulin you can give blood! (As always, check with your doctor first)
- Sensor Application - 1-2 hours. Because I am a female I did have to do a pregnancy test when I got there. Once that came back negative we got down to business. They asked a few questions to make sure that nothing changed from the screening visit. They gave instructions to not put any adhesives on the sensors, to keep the readers charged, and to scan at least 1 time every 8 hours (I shot for every 6 hours to make sure I didn't miss one). They also said that if I have any medical changes while I am wearing them (ie new medication) to document it and let them know at the next appointment. During the time wearing them I should probably not get any x-rays or MRIs if I can safely avoid needing them. If I have any concerns or bad reactions I am to call them, day or night. And to also not take any Vitamin C. They then gave me two Libre Sensors and two Libre Readers. They had me insert one on my left arm and one on my right. We started the sensors and because this system is an ‘investigational device’ so I don’t see the numbers on the readers when they are scanned. This is to ensure that they are not being used to make decisions for treatment. I waited until the warm-up period had ended, 1 hour, they verified that the settings were correct on the reader and sent me home. Now I just wear them until the clinic day.
- Clinic - 13 hours (AHHH!!!!!!) They check the sensors and verify that the readers are receiving a reading. They place an IV in my arm which will have a heating pad over it. For the first hour, they will be taking blood from the IV every 10 minutes. For the last 12 hours, they will be taking blood every 15 minutes. Each time they take blood, the sensors are scanned. This way they can compare the lab value with the reading value. At the start of the 2nd hour, they will give a 1,000mg dose of Vitamin C. A second dose at hour 5 and a third dose at hour 9. At the end of hour 13 the sensors are removed and I go home.
*On a side note, a huge perk to participating in the study is the….compensation! For 4 days of wearing the sensors, 13 scans at home, and a 13-hour clinic, I am getting reimbursed just under $800!
In preparation for this day, they let me know that they would be providing meals, snacks and drinks. They have a TV with streaming services, wifi, and comfy chairs. They kept saying it was a long day…...and to be prepared and bring whatever I needed. So I made my list. Book, Charger, computer (so I can work), computer cord…… I just hope that is all that I need.
On the day I got there and they placed my IV. There were 5 of us in the room. I got to pick the first movie. They staggered our blood draws so we weren't at the same time. When they drew the blood we scanned both sensors. Our arms with the IV had a warming blanket over them. (Which I got to take home) They fed us sausage and egg McMuffins for breakfast, chicken wraps and a side salad for lunch, and salmon, green beans and Mashed potatoes for dinner. At each meal we took 100mg of Vitamin C. Usually we take turns picking movies but the guy next to me "lets his grandkids run that thing". So we put on a series. There were type 1 and 2's there. Anytime we shot a correction or bonuses for a meal they documented it.
At the end of the day, they removed the iv and sensors. We returned the receivers and left. I had my check a week later.
Would I do it again? YES! I have a medical condition that doesn't have a lot of positives to it. If I can use it to help other diabetics have better care or more options, I am all for it. For some, it isn't something they want to do but I liked it. Now that I have completed one study they have my name, contact info, and medical history and will invite me for more.
If that is something you are interested in I'd highly suggest seeing if there are any studies near you. Near me, there are a few sensor studies, pump/sensor studies (I am starting a one in about a month) and medicine studies. There are several to choose from, so you don't have to do one that you are uncomfortable with.
-Kami (Diagnosed in 2009)