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iPro Trial - Medtronic

 

When my daughter was diagnosed with Type 1 diabetes more than five years ago, I wanted the latest and greatest diabetes management tool for her–an integrated insulin pump/continuous glucose monitoring system (CGM). But one issue weighed on heavily on us. Would insurance cover the CGM?

Through research, I learned about a trial with Medtronic’s iPro, a clinical version of a CGM, that’s inserted in the endocrinologist’s office, worn for three days, and then returned to the doctor. The data is then uploaded and analyzed to determine sufficient need for a CGM, warranting coverage by insurance. I decided to be proactive and arranged an iPro trial for Kate. The trial gave her an opportunity to learn what CGM insertion felt like and what it would be like to wear a CGM. After a few hours, she forgot the device was even there. The data showed significant swings in glucose level, including lows. She was quickly approved for the CGM and continues to wear it daily.

I had all but forgotten about the iPro trial until a recent meeting with Medtronic’s Hiten Chawla, Senior Director of Global Marketing for the Non-Intensive Diabetes Therapies, at the Medtronic Diabetes Advocacy Forum.

Chawla shared information about the new iPro2 and the benefits its evaluation provides for those with Type 1, Type 2, and gestational diabetes. “Patients who are not at their A1C target regardless of what therapy they are being treated with — diet and exercise, oral medications, GLP1 injectable or insulin,” are all good candidates for an iPro2 evaluation. Chawla added that those with diabetes who are changing their diabetes regimen, have nighttime hypoglycemia, dawn phenomenon, hypo unawareness, significant post meal high blood glucose, moderate to severe neuropathy, or are pregnant would benefit from an iPro2 trial.

The iPro2 is a “blind” trial, meaning that the patient does not see the data in real time and is expected to maintain a normal daily routine, which, according to Chawla “enables the physician to get a truer picture of what is going on. This creates a ‘teaching moment’ at the time of the office visit.” The doctor is able to use the iPro2 Pattern Snapshot report which gives results at a glance by focusing on the top three patterns observed during the evaluation.

iPro Many of us in the Type 1 community are aware of the value of CGM data. But Chawla added that Type 2s , even those not using insulin, can learn from the evaluation. He related a personal story about his own mother, who has Type 2 and is on Metformin twice a day. She rarely checks her blood sugar “despite the fact that her son is in this field for the last 8 years,” he added with a smile.

“She loves her food, and especially mangoes during the summer. That’s when it ‘s the hardest for her to watch her diet as she will often eat at least one or two mangoes with each meal. In addition she would deliberately avoid checking her blood glucose with a meter or time it at such (before breakfast) that things would seem ok.”

Chawla tried to convince her that she needed to be checking glucose levels more. But like many with Type 2 diabetes, she is not on insulin and doesn’t dose her medication off of glucose levels, so she doesn’t fully understand what to do with her blood sugar readings.

Last summer during a visit with his mother, Chawla decided to push the issue and insisted that she get an iPro2 evaluation. She didn’t feel the iPro2, and per Chawla’s instructions, kept to her normal diet and lifestyle — even eating her usual amount of mangoes.

Her follow-up visit with her doctor was an eye-opener. According to Chawla, “for the first time she was able to see what her choices on food and exercise (or lack of it) were having on her glucose levels.” Chawla said, “I have been saying this to her for the last five years. She responded by saying ‘a picture is worth a thousand words, son!'”

Mrs. Chawla also found that the doctor spent more time going over specifics and setting clear objectives. She even said she wished she had done the evaluation sooner as it was so simple. Chawla related that she said “Why didn’t you ask me to do it earlier?” She failed to recall that I had asked multiple times and it took me to be physically present and not taking no for an answer this time to get her to do it.”

If you are interested in an evaluation, your primary care physician may either conduct the evaluation or refer you to an endocrinologist. Insurance covers the evaluation as it is considered an out-patient diagnostic procedure. Typically, insurance covers the evaluation at least twice a year.

*Disclosure: Medtronic covered my expenses (food, travel, lodging) for the Diabetes Advocacy Forum in April 2016. Our personal experience with the iPro occurred in 2011.

 

Robin Cacopardo
Robin Cacopardo

Robin Cacopardo and her family split their time between the mountains of East Tennessee and the North Carolina coast. Her oldest child, Nick, has a severe food allergy. Her youngest, Kate, was diagnosed with Type 1 diabetes in 2010 at the age of 10. Kate took part in the University of Virginia Artificial Pancreas clinical trial. Robin’s years as a high school teacher are being put to good use as she navigates the world of parenting teens. She is also part of the team of amazing D moms behind www.projectbluenovember.com

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