A Landmark IDEA Aims to Change the Course of Diabetes Care

By Mary Green
IDEA article header

The American Association of Clinical Endocrinologists Spearheading Breakthrough Program

In the 19 years since the Food and Drug Administration first approved continuous glucose monitors (CGM) for use in the U.S., the still-evolving technology has become a potential game changer in diabetes care.

The small, wearable device consists of a sensor placed under the skin that relays information to an attached external transmitter that tracks blood glucose (BG) levels in the cellular fluid at regular intervals, 24 hours a day, without the need for a finger stick. The resulting contextual data, sent to a separate receiver, allows patients and – by extension – their caregivers and their diabetes healthcare team, to proactively manage glucose highs and lows while providing added, real-time insights about the impact that food intake, exercise, illness and even everyday stressors have on an individual’s BG levels, thereby reducing the guesswork that often goes into glycemic control decisions.

Despite CGM’s capacity to provide “actionable” BG information to guide daily diabetes management (and thereby decrease the potential for devasting disease complications), widespread acceptance of CGM has been slow-going, some would suggest. There are a number of reasons for this.

First, each CGM device manufacturer has its own proprietary software and, thus, produces a different report. The resulting lack of uniformity and standardization in CGM reporting has created significant challenges for healthcare professionals and their patients in how to best use CGM-generated information to improve everyday diabetes care.

"The project is now taking shape and has the potential to change how doctors help their patients and how people with diabetes can better manage their blood glucose safely and feel better as a result…"

“Additionally, physicians don’t fully understand CGM use or think it may require too much effort, plus many people living with diabetes and their caregivers are not aware of the CGM technology, how it works and the many benefits it may provide them,” says Nancy J. D’Hondt, a clinical pharmacist and immediate past president of the American Association of Diabetes Educators (AADE).

That’s all about to change.

A collaborative of powerhouse organizations in the diabetes health care space is intent on taking CGM use to the next level, joining forces in an unprecedented effort to ensure all diabetes health care professionals and patients have the information and tools they need to make the most informed clinical decisions possible about CGM use.

Known simply as IDEA (Innovating Decisions and Empowering Action in Diabetes), the focus of the multi-year initiative is to create and deliver comprehensive, easy-to-understand educational/awareness materials and learning aids to stakeholders across the diabetes care spectrum, with materials designed for patients, diabetes specialists, primary care physicians, nurse practitioners and physician assistants, and educators such as registered nurses, pharmacists and certified diabetes educators. The materials will provide the uniformity necessary for CGM use to reach its full potential, notes D’Hondt, a member of the IDEA steering committee.

“More widespread use and understanding of CGM can have benefits for all,” she says. “For physicians, it can help guide medication change therapies or insulin dosing and determine what’s working and, possibly, what’s not. For people living with diabetes, it will improve understanding of what and how food, activity, stress, medications and life in general affect blood glucose, mood, sleep and health. And family members will be able to monitor glucose values remotely and ensure safety for their loved ones.”

At present, A1c – a measure of a person’s average blood glucose levels over a two-to-three-month period – is widely used and generally considered to be the gold standard in assessing blood sugar control to mitigate long-term risks of complications from high blood sugar levels. However, A1c can’t capture other critical data that matter to a patient on a daily basis, for example, low blood sugar (hypoglycemia) episodes that can be potentially fatal.

“This effort will shift the focus of diabetes management from A1c-centric to time-in-range-centric blood sugar goals and thereby improve overall outcomes and improve the lives of people living with diabetes,” says J. Hyun (C.J.) Chun, president of the American Society of Endocrine Physician Assistants (ASEPA), also a member of the IDEA steering committee. (Time in range is the percentage of time that a person with diabetes spends in the ideal blood glucose range.)

Although the IDEA program team began its activities in early 2018, the groundwork for the initiative was actually laid several years ago when the American Association of Clinical Endocrinologists (AACE) held a CGM Consensus Conference to examine the growing body of evidence supporting CGM benefits and develop strategies for overcoming barriers to CGM use and access.

“We asked ourselves, ‘How do we have a call to action to develop a unified approach to interpretation of CGM data that we could use to manage a patient’s diabetes, realizing, of course, that patients are being managed by a variety of healthcare professionals, and who is going to teach the patients and those providing the care how to capture the real-time data to enhance understanding and use of the technology?’” recalls endocrinologist Dr. George Grunberger, an AACE member and IDEA project steering committee chair.

“From there, the idea was to first get buy-in and agreement from each CGM device manufacturer to develop a unified report that could be used for educational purposes by everybody, from endocrinologists to primary care physicians to diabetes educators and so forth, so that the patient could be properly educated and caregivers could define what comes next in that patient’s treatment routine,” he adds.

Despite the highly proprietary nature of CGM manufacturers’ technology, all of the companies in the arena agreed to the proposition.

Another key development was the involvement of the International Diabetes Center, which owns the copyright to the Ambulatory Glucose Profile, the report forming the backbone for the IDEA unified CGM report.

The AACE team then identified key organizations that had a stake in the issue and solicited their participation in the program.

“Buy-in was quick,” Dr. Grunberger says. “It was impressive and exciting to see how many organizations enthusiastically joined almost immediately.”

Program participants include AACE, AADE, American College of Clinical Pharmacy (ACCP), American Diabetes Association (ADA), ASEPA, College Diabetes Network (CDN), Diabetes Patient Advocacy Coalition, Endocrine Society, JDRF, The Leona M. and Harry B. Helmsley Charitable Trust, International Diabetes Center (IDC), T1D Exchange and The diaTribe Foundation/Close Concerns.

“Right now there’s a lot of work to be done,” Dr. Grunberger notes. “We are finally organizing all these pieces and gathering content for the learning program launch, which is planned in late 2018.”

“The project is now taking shape and has the potential to change how doctors help their patients and how people with diabetes can better manage their blood glucose safely and feel better as a result,” D’Hondt adds. “This technology can be a game changer when it comes to a better understanding of living and thriving with diabetes. We just need to make it a part of the care plan for all.”

To learn more about the benefits CGM has provided patients, read on for some first-hand CGM user stories.

Carol Logan

My CGM Story: Carol Logan

Minneapolis, Minnesota

To the casual observer, Carol Logan might seem an unlikely fit for a person at risk for diabetes.

An accomplished linguistics teacher who has lived, worked and traveled across the globe, from France, Yugoslavia and Finland to England, Greece, Russia and Israel, Logan has led an active, productive life and is fit, trim and exceedingly health conscious.

So nobody was more surprised than Logan herself when she was diagnosed with type 2 diabetes in July 2001, at the age of 58.

“I had none of the telltale signs of uncontrolled diabetes at the time of my diagnosis,” she notes. “I wasn’t thirsty, I wasn’t urinating excessively, I hadn’t lost weight, I wasn’t hungry. In fact, I found out about it from a random blood sugar test.”

Logan had been proactively having her blood tested every six months at her local pharmacy due to an extensive history of heart disease on her father’s side of the family. “They did a routine fasting blood sugar in addition to testing my cholesterol levels, which were excellent, as they usually are,” she says. “But they advised me at the time that my blood sugar was a little high.”

An A1c test done shortly thereafter – a measure of a person’s average blood glucose levels over a two-to-three-month period – was also slightly high, but still within a normal range, Logan says.

Her doctor subsequently advised her to buy a glucometer, a medical device used to determine the approximate concentration of glucose in the blood, and to test herself randomly four times a day.

“To my horror, I found that every time I tested myself after a meal, it was 170 or 180,” she recalls. For most people, a normal fasting (no food for 8 hours) blood sugar is between 70 and 130; a normal blood sugar level two hours after eating is less than 140.

“So, they put me on all different kinds of oral medications for type 2 diabetes to try to get my blood sugar back to normal, because they thought I had type 2 diabetes,” she says. “The medications never worked. I was constantly testing myself, and my results were always abnormal.”

In January of the following year, frustrated with the lack of results, Logan told her doctor she was willing to consider insulin therapy. Ultimately, Logan was correctly diagnosed with type 1 diabetes through a C-peptide test that indicated her body was producing no insulin. “And that’s when I started taking shots,” she says.

“In my case, I knew all about diabetes therapy because we had had a baby with the disease who was on insulin shots, so I wasn’t afraid of them,” Logan says. (Her son David now in his 40s, was diagnosed with type 1 diabetes at the age of 20 months, although nobody on either her side or her husband’s side of the family had ever been diagnosed with the disease.)

She continued conventional insulin therapy and tested her blood sugar frequently to stay on track in the ensuing years. “I’ve always been an advocate of tight control to avoid the horrible side effects of type 2 diabetes and know exactly what all of my blood sugars are at any moment,” she advises.

It was through an Adults with Type 1 support group that she first learned about continuous glucose monitoring (CGM). “Word-of-mouth from the many people with diabetes I knew who had a CGM and who raved about how fantastic it was and how much it helped their control was what piqued my interest,” she says.

The technology had particular appeal due to a potentially dangerous condition Logan suffers from called hypoglycemia (low blood sugar) unawareness, a complication of diabetes in which the patient is unaware of – or doesn’t experience – the hallmark symptoms that accompany a deep drop in blood glucose levels. Hypoglycemia unawareness can lead to seizure, loss of consciousness, even brain damage. It also makes intensified blood glucose control more difficult and puts the patient at risk for severe hypoglycemia-related complications.

Carol and Richard Logan in Jerusalem
Carol Logan with her husband Richard (left) and together visiting the famous Western Wall in the Old City of Jerusalem (above).

When she mentioned conversations about CGM with her fellow support group members to her endocrinologist, Logan’s caregiver agreed that it could be a valuable tool in her diabetes regimen. “Her concern was that with my having this unawareness problem, I could become unconscious while driving, for example,” Logan says. “But with the CGM, it starts beeping to warn you that your blood sugar is getting low.”

She began using the technology in 2008.

“The hardest thing about having diabetes is not taking your shots or testing your blood, it’s that you can never forget about it,” Logan concludes. “But still, it’s so much better now than when my son was diagnosed, when there was only urine testing available. I mean, it’s like a miracle when you compare the two time periods in history.

“To be honest, I can’t even remember what it was like in those days before I started using the CGM,” Logan says. “Because I’ve had diabetes for so long, it’s comforting to be able to look at the CGM at any time, day or night, and see what my blood sugar is approximately. And then if I have any doubts, I can always check my blood sugar with a finger prick. I still test myself about 6 to 8 times a day, and I don’t mind doing it.

“I’ve come to depend on it so much, if I ever happen to forget it and go somewhere without having it with me, it’s a horrible feeling,” she continues. “I feel like I’m naked. And I’m sure everyone who has a CGM feels that way.”

Stacey and Benny Simms

My CGM Story: Stacey Simms

Charlotte, North Carolina

Day-to-day life changes instantly for people when diagnosed with a chronic medical condition like diabetes. It often means big changes for their loved ones as well.

And so it was with Stacey Simms and her family – daughter Lea and husband Slade – when her youngest child, son Benny, was diagnosed with type 1 diabetes in December 2006, just before he turned two.

“I was slightly familiar with diabetes, and Benny had all the classic symptoms,” says the award-winning broadcast journalist. “Through the radio station I worked for, I had been involved in several local JDRF (formerly the Juvenile Diabetes Research Foundation) events, so I was familiar enough with the signs that I called my pediatrician and suggested our son needed to be tested.”

At the time of his diagnosis, the toddler’s A1c (a measure of average blood sugar levels over a two-to-three-month period) was 11.5. A level below 5.7 percent is considered normal. His blood sugar was over 800; less than 140 is considered normal.

“It was straight to the pediatric hospital, but he responded to treatment really well, so they only kept us for three days,” Stacey recalls. “He felt pretty good and was running up and down the hallways. The nurses were so happy, because a lot of kids with the same diagnosis don’t feel well enough to do that.”

Once the family brought Benny home, it was another matter entirely.

“Type 1 diabetes in a toddler is a very, very different thing,” Stacey notes. “The first two weeks were horrendous. He would run away from us, he would cry, he didn’t want the shots, he didn’t want the finger sticks, but after two weeks he began to adjust beautifully. Kids that age get used to things very quickly if you just get on with it.

“Our care at the time was to give fast-acting insulin when he ate, but our endocrinologist didn’t supply us with a strict eating plan, so whatever he ate, we gave him a shot to cover for that,” she continues. “He was up to six or seven shots a day, but he didn’t care how many shots a day he got, as long as he didn’t have to stop playing or interrupt his ‘fun’ time.”

Still, challenges remained.

The family had a big scare only a month after Benny’s diagnosis during an outing to visit relatives. “We were all at an indoor play area and I thought he was taking a nap, but I decided to check his blood sugar just in case,” Stacey says. “I don’t recall the exact number, but it was definitely under 50.

“We were terrified because it was so soon after we found out he had diabetes, and we were running to grab juice and gummies, but he was too tired to eat the gummies, so we went back to the juice to increase his blood sugar,” she continues. “After the episode was over, I remember thinking at the time how amazing it was that he bounced back from the low sugar so quickly.”

“Still, the most difficult thing was that we never knew if he was falling asleep or if he was experiencing a low, because most children that age can’t articulate how they’re feeling. No two-year-old says, ‘I have an ear infection,’” Stacey recalls.

“You’re checking blood sugars through your child’s crib’s slats at night, and finger-sticking before, during and after any activity, even if it was only half an hour, because his blood sugar levels could go down very quickly from 120 to 40,” she adds. “After all, he only weighed 35 pounds! It’s a combination of heartbreaking and funny in an odd way.”

Over time, Benny’s care became easier and the family settled into a routine, even though there were still ups and downs. And Benny eventually transitioned from shots to an insulin pump.

The Simms family
Stacey Simms with her son Benny (left) and family (above) – Benny, Lea and husband, Slade.

Meanwhile, Stacey had become a passionate advocate for her son and others with diabetes (a so-called “D-mom”), joining the local JDRF board in Charlotte six months after Benny’s diagnosis and blogging as an outlet for the emotions and challenges the family was experiencing. “It lifted the burden just to share it, to realize that we were not alone,” she says. That yearning for a sense of community ultimately led Stacey to launch her own podcast, Diabetes Connections (https://www.diabetes-connections.com/). The popular weekly talk show includes a mix of interviews with prominent diabetes advocates, authors and speakers, researchers, and people with diabetes, their friends and family members.

Stacey’s involvement with the diabetes community, as well as Benny’s participation in camps for children with diabetes, initially made the family aware of CGM technology, “We saw people using the gear, but Benny didn’t want something else on his body, and we didn’t want to push it,” Stacey notes. “And then he came home from camp in 2013 after seeing another child using CGM, and said, ‘I want to try this.’”

Her son began using CGM Christmas day 2013, “and it was just INCREDIBLE,” Stacey says. “We all could see his blood sugar number on the receiver and that was such an eye-opener. It was so interesting to see and absorb, I remember we just stopped in our tracks and stared at it for the longest time.

“It took a while for us to learn how to use it, because when you finger stick, even six to eight times a day, or 10 times a day, as we often did with him, you’re not getting the full picture,” she adds, “but you’re also not overreacting. It took me a little while to learn how to not overreact because with CGM you get so much information that you didn’t have before, it’s an art form to find balance.”

With the advent of CGM remote monitoring, in which CGM data from a receiver can be stored on a web-based server instead of specific devices, allowing multiple caregivers to remotely view a person’s glucose data in real time, there were more lessons to be learned…and gains to be had.

Although acknowledging her instincts after Benny’s diabetes diagnosis were to “put my child in bubble wrap and never leave his side,” Stacey and Slade had agreed that teaching their children independence and confidence were priorities. “So, our remote monitoring of Benny was, and continues to be, a whole other bag of beans. We’ve got his blood sugar numbers on our phones, we know our child can handle it, but at the same time he’s showing as having a high and you want to tell him, ‘knock that down.’ However, you can’t text your child 400 times a day. It’s taken some really honest conversations to work out a system that works for everyone in our family.”

The good news? Benny is now an active, strapping 13-year-old living the life of a typical teenager, thanks, in part, to CGM technology.

“CGM has taught us so much about how insulin works for Benny, when to dose and how certain foods affect him,” Stacey says. “My husband is one-half Italian and owned an Italian restaurant for many years, so food really plays a big part in our family’s life. If we’re going to eat a high-carb or high-fat meal, CGM helps tell us how his body reacts so we can time his insulin a lot better, and he doesn’t have to give up his favorite foods. It’s also helping us ride the swings of puberty.

“CGM has become integral, almost essential, to our care.”

Mike Ratrie

My CGM Story: Mike Ratrie

Mount Dora, Florida

Mike Ratrie’s pathway to continuous glucose monitoring (CGM) use was a long time coming.

Forty years, to be exact.

Diagnosed with type 1 diabetes (T1D) in 1973 at the age of 19, the active, outdoor enthusiast was being cared for by an internist who prescribed intermediate-acting NPH insulin once a day and was enduring “dozens of daily finger sticks” to assess his blood sugar levels. “Keep in mind, this was back in the day of peeing on test tape or measuring urine sugar level in test tubes,” Ratrie says, “long before there were meters for measuring blood sugar.”

Remarkably, Ratrie’s diabetes regimen remained consistent for more than two decades. Over time, however, his insulin dosage had increased from 35 to 40 to 55 units per day, “and I still wasn’t feeling that great,” he recalls.

Following his internist’s retirement, and after hearing from a male acquaintance about his state-of-the-art T1D care, “that got the wheels turning,” Ratrie says. “I did some research and discovered endocrinologists who specialize in treating patients with diabetes. I didn’t even know such an animal existed.”

Shortly thereafter, he made his first visit to a diabetes specialist. “She opened up a whole new world for me. She was truly, in diabetes care terms, really a world-class endocrinologist,” he says.

“She started me out doing finger sticks,” Ratrie recalls. “I came back after a month, and she took a look at my blood glucose numbers, which were mostly up in the 180 to 250 range, and she told me I really needed to be down below 120. And I was like, ‘Oh, no.’ At 120, I’m eating everything in sight because that’s too low a blood sugar for me,” he continues. “So she suggested we try to get the blood glucose down gradually.”

Ratrie’s endocrinologist also educated him about the complications that happen internally to a person with diabetes when their blood sugar isn’t under control. “Those were some really eye-opening times for me,” he says. “She wasn’t dogmatic, she talked about goals we could achieve together, as partners in my care.”

Mike Ratrie on a recumbent tricycle
Mike visiting Oregon's coast during his cross-country cycle journey.

Despite their productive partnership, Ratrie metaphorically “moved on from her” for five years while he lived on a sailboat, traveling from Maine to Chesapeake Bay to the Bahamas and down to the tiny southern Caribbean island of Aruba. “But she was my endocrinologist from afar, as I was coming back to the U.S. once a year to see her and get prescription renewals, test strips and so forth,” he says. “I actually had an area on the boat that was dedicated to these huge containers where I had my test strips to check my blood sugar levels.”

After his return to the U.S. in 2011, he noticed people were starting to talk about CGM. “I was doing a lot of reading on the technology and was involved in a lot of online forums, but I was resistant to it initially because I was reviewing literature that talked about how you calibrated CGM with a blood stick device, which had about 20 percent plus or minus accuracy, and the logic wasn’t really striking me as being very compelling,” he says.

“I finally got to the point where I wanted to get more data, because even doing finger sticks 12 or 15 times a day, which is what I was doing, you’re only getting a snapshot,” he adds. “Imagine trying to tell a story with 15 pictures, or with a movie that is a series of hundreds of pictures. That’s the difference.”

Ratrie began using a continuous glucose monitor in 2015…and has never looked back.

“I don’t recall if I was necessarily taking advantage of all of the information I was collecting, but I really picked up on the fact that this technology was going to help me immensely, because you can tell what’s going on with the blood glucose trending, which allows me to take corrective steps sooner,” he notes.

"The CGM helps me take advantage of the information and take steps sooner before I get in trouble from extreme blood sugar highs or lows. That’s really key."

“What was eye-opening was seeing things I had been missing,” he continues. “For example, I would do a finger stick and have a picture of a post-meal number of 180, and then I’d see on the CGM that that’s not my peak. My blood sugar was still going up. And it really helped me understand I needed to be a little more aggressive if I hadn’t counted my carbs correctly, or if there was something going on with my metabolism that would tell me that I was going to be out of range, either high or low. The CGM helps me take advantage of the information and take steps sooner before I get in trouble from extreme blood sugar highs or lows. That’s really key.

“I’ve realized how much better my level of care is with CGM than it is with finger sticks,” Ratrie adds. “I can’t tell you before I started using a CGM what percentage of time I was spending over 180, but just as an example, in the past six months I’m spending maybe 3 or 4 percent of the time above 180.”

Ratrie’s CGM use was crucial to his most recent adventure, a 2016 cross-country bicycle trip with his wife, Lucia. He says the four-month, 5,885-mile journey in which they rode their ICE (Inspired Cycle Engineering) recumbent tricycles from Seattle, Washington through 15 states and back to their Florida home would not have been possible without his CGM.

“Having that CGM with me so that I could understand where my blood sugars were was priceless,” Ratrie concludes. “CGM, for me, has just been so wonderful and so eye-opening, and it helps me not worry as much about my diabetes. Even though I have to spend time paying attention to it, it helps me live closer to a normal life.”