Diabetes data hold hidden clues, but time, costs complicate clinic downloads

As diabetes technologies continue to evolve and improve, so does patient uptake. According to 2013 data from the T1D Exchange annual State of Diabetes report, 58% of adults and 59% of children with type 1 diabetes reported using insulin pump therapy, and 13% of adults and 5% of children reported using continuous glucose monitors.

Data downloaded from these devices, as well as data from new “smart” blood glucose meters, can offer clinicians the missing clues needed to better understand why a patient has poor glycemic control; however, many clinicians are not actively reviewing these data due to time and cost concerns, experts told Endocrine Today.

“Downloading of the technology — from meters, pumps, continuous glucose monitors — needs to be part of the vital signs for every patient with diabetes,” Irl B. Hirsch, MD, professor of medicine at University of Washington School of Medicine, told Endocrine Today. “A download should be done on every patient.”

In patients with diabetes, reliance on an HbA1c value alone can be misleading, Hirsch said. Hematologic conditions, physiologic state, medications, comorbidities and medical therapies can all result in an altered HbA1c in patients.

“We have become too HbA1c-centric, and it’s time to become more glucose-centric, because we now have the glucose data,” Hirsch said during a presentation at the American Association of Clinical Endocrinologists annual meeting in Austin, Texas. “We’re not fighting the HbA1c. We’re fighting the glucose, both on the hyperglycemia side and the hypoglycemia side.”

For many providers, multiple hurdles make downloading data a difficult prospect to squeeze into an already brief clinic visit.

“In the pediatric diabetes clinic, we might have half an hour for a patient visit, but you might use 10 to 15 minutes just to download the data, and then you need time to actually review the data,” Jenise C. Wong, MD, PhD, assistant professor of pediatrics in the division of endocrinology at the University of California, San Francisco, told Endocrine Today. “Traditionally, that has been challenging when you have siloed information. You have the insulin pump data here, CGM data in another place and your blood glucose data from the meter in another place.”

Technical hiccups also complicate downloading time, Wong said.

“It takes time for the front desk staff — or, maybe it’s a certified diabetes educator or the clinicians themselves — to log in and download the data,” Wong said. “And, there are technical problems. Maybe a patient forgot their password, or you don’t have the right software, or devices are not compatible with the operating system. The technical part is standing in the way.”

Time is at an even greater premium for primary care physicians, who typically are not trained to interpret diabetes data, according to Satish K. Garg, MD, professor of medicine and pediatrics at the Barbara Davis Center for Diabetes, University of Colorado Denver.

“Many primary care physicians have no clue how to manage diabetes based on the sensor data,” Garg told Endocrine Today. “Even if they want to, the total time for a primary care visit — which is where 90% of diabetes cases are seen in the U.S. — is 15 or 20 minutes per patient. Right now, there are 20 different pages that are printed from every CGM download, and every company has a different way to download.”

Often, Hirsch said, there is no infrastructure to properly download data in the office, leading to poor efficiency and the perception that there is not enough time. Downloading data is also a relatively new trend, Hirsch said, and many endocrinologists were never taught how to do it.

“We [teach] this with the fellows every year, but I can tell you that 50% of the endocrine programs for fellows today don’t have a diabetes clinic that does this on a routine basis,” Hirsch said.

Exactly how many providers download diabetes device data during clinic visits is unknown, but surveys suggest numbers remain low. At the 2014 American Association of Diabetes Educators annual meeting, a poll revealed that just 5% of attendees worked with physician providers who routinely downloaded CGM and insulin pump data.

“We talk a lot about using devices,” Wong said. “What we don’t talk about is, what do we do with the information from them? That’s a critical part of the technology, and not using the data is really a missed opportunity for providers and patients.”

A fuller picture

Downloaded data, Hirsch said, will show clinicians the glucose variability — time spent in range, time above range and time below range — that is often hiding behind an HbA1c value. With an HbA1c of 8%, for example, the mean glucose range is between 120 mg/dL and 210 mg/dL, Hirsch said, and downloaded data will show where a patient is from day to day.

“I want to know about the variability,” Hirsch said. “The greater the variability, the more I know that they’re not making their own insulin ... and the greater the risk of bad hypoglycemia.”

Patients generally make four common mistakes when managing their diabetes that data downloaded from a device can reveal to a clinician, Hirsch said. These include over-calibration or under-calibration; not looking at the sensor often enough; overreacting to alarms, resulting in “insulin stacking;” and not using self-monitored blood glucose values to make decisions.

“Sometimes the Dexcom CGM says you’re low ... and you’re not,” Hirsch said. “When there is a question, you should follow up with a finger stick.

“One needs to see both cumulative and detailed data to understand how to assist their patients,” Hirsch said. “What I do in my clinic may be different from what you want to do. There are a lot of different ways to do that.”

The data also offer a peek into patient behaviors that, with changes, may easily correct the course for a serious problem, such as the timing of insulin doses, too much basal insulin or missing prandial injections, Timothy S. Bailey, MD, FACE, CPI, director of the AMCR Institute and clinical associate professor at the University of California, San Diego, told Endocrine Today.

“Glucose is invisible,” Bailey said. “Unless glucose is super high or super low, there are no immediate consequences. The patient just thinks they’re having a bad day.”

To download data in the office, clinicians need an infrastructure that allows for downloading from various brands of meters, insulin pumps and sensors. The most common software, Bailey said, comes directly from device manufacturers.

“This is both a blessing and a curse,” Bailey said during a presentation at the AACE annual meeting. “The device manufacturer knows their device the best, so their software is the fastest software. But it can be a curse, if you don’t like the reports. It can also be a curse because every company has a different form of a different report, and it can be very confusing to your staff.”

Other options, such as Glooko and the nonprofit Tidepool, aim to be “device-agnostic,” Wong said, incorporating data from multiple devices into one interface. Tidepool, for example, has developed a cloud-based, open-source, HIPAA-compliant platform that allows aggregation of data across all diabetes devices. The software is free and provides unlimited storage.

“This helps in the long term, because the provider has one way of looking at data,” said Wong, who uses Tidepool in her practice. “The other advantage is for downloading the data — there is just one tool.”

Mobile apps can also serve as an option for monitoring data, Bailey said; some can provide tracking, motivation or insulin-dosing calculators. To cut down on time spent downloading in the office, Bailey recommends using devices with cloud-based technology. For example, the Dexcom and Medtronic CGMs have apps that allow cloud uploading automatically.

“Some CGM data can now be uploaded automatically, whether that is to the device manufacturer’s proprietary software or to Tidepool,” Wong said. “That removes barriers, because you, as the provider, don’t have to connect the CGM, wait and deal with technical problems in clinic, it’s already done. If something unusual is going on with a patient’s glucose levels at home, the patient can contact the office and say, ‘Hey, can you review the data?’ And it’s already there. That is making a big difference for us.”

Reimbursement navigation

In a report commissioned by the AADE in 2014 to outline current practices related to the collection and use of patients’ diabetes-related health data, the authors noted that reimbursement for time spent downloading and interpreting data remains a problem.

“The [U.S. CMS has] historically been reluctant to reimburse providers adequately for diabetes self-management education (DSME),” the report states. “Unless providers can use codes for SMBG meter data interpretation, behavior change, or telehealth provision, diabetes data interpretation is treated similarly to DSME overall.”

There are currently no codes for initiating insulin pump therapy or CGM, Bailey said, although there are options to code for reading CGM data and initiating professional CGM, which uses the office’s technology and where real-time data are not available.

“If data review is done in a clinic visit, you can bill using the code for CGM review, but there’s not an equivalent for meter data or pump data,” Wong said. “It would be nice to have that.”

Wong said her office sometimes schedules and bills for telemedicine encounters when reviewing data with patients between visits.

“We’re encouraging families to download between clinic visits. Especially if they live far from the clinic, we might schedule a telemedicine visit, review data together, and can then bill for the visit and CGM data review,” Wong said. “It’s indirectly addressing reimbursement. Getting ‘credit’ is a big challenge, and if you have a busy practice, data review may fall by the wayside.”

Bailey also said the use of a company representative to initiate CGM or pump therapy with a patient is an option for endocrinologists to save time and cut costs.

A ‘diabetes ECG’

In a consensus statement on glucose monitoring jointly released by AACE and the American College of Endocrinology in 2015, committee members highlighted a lack of standardized reporting across diabetes devices that complicates clinical care.

“Participants agreed that much future research is needed on effective and efficient ways to upload, analyze and visualize glucose data in a standard manner and then effectively use those data to make clinical decisions,” the committee wrote. “Thus, the availability of accurate glucose meters and established ways to effectively use the data to avoid wasting resources are both important factors.”

Bailey said diabetes data should be standardized similarly to an ECG report.

“An ECG is valued by patients, valued by physicians, valued by insurance companies; it has implications, and it is reimbursed,” Bailey said. “It’s standardized, it’s a skill that is taught in medical school and it is reinforced in residency. A ‘diabetes ECG’ would tell you if things were in trouble, but the opportunity that we have for a diabetes ECG is a patient-facing version.”

Garg also embraced the ECG metaphor.

“With every ECG, you never ask, which machine printed this?” Garg said. “The machine will interpret for you. Right now, there is hardly any interpretation with diabetes devices and data. It should be a one-page report summarizing key components.”

Garg said talk of standardization among the FDA, National Institute of Diabetes and Digestive and Kidney Diseases and academia is becoming more urgent, and device makers will soon need to come together to create a standardized reporting system.

“It will happen,” Garg said, “because the way it is right now with data, it’s garbage in, garbage out.”

“There are many ways you can criticize this,” Garg said. “To some extent, the companies are at fault. That’s why the physicians are not paying much attention to data and thus, they don’t advise their patients to go on the technology. But, as the technology is improving and as they are starting to standardize the reporting, I think it will get reasonably well used, just like the ECG is. I hope so.”

Bailey agreed.

“We’ve got the technology, we’ve got more sophisticated algorithms to standardize reporting,” Bailey said. “The problem is implementation.”

‘Conversations that aren’t happening’

In a study published in the January issue of the Journal of Diabetes Science and Technology, Molly L. Tanenbaum, PhD, an instructor in the division of endocrinology and diabetes at Stanford University School of Medicine, and colleagues surveyed 209 diabetes providers, including CDEs and dietitians (22%), CDE/registered nurses (21%) and endocrinologists (15%), recruited from the T1D Exchange Network and dQ&A, a diabetes market research company. Participating providers were asked to identify patient barriers to using both insulin pumps and CGM.

The researchers found that the providers endorsed barriers more frequently than patients across all categories. Nearly half of providers thought the barrier, “do not understand what to do with the information or features of the device,” was keeping patients from adopting the technology. In the related survey of 1,503 patients, however, just 4.5% of adults endorsed that reason. Nearly 40% of clinicians also responded that “nervousness to rely on the technology” was a barrier to CGM and pump use, compared with just 17% of the adult patients surveyed.

That disparity between provider and patient, Tanenbaum said, may influence uptake and adherence to diabetes devices.

“Hardly any patients said that they didn’t know what to do with their devices, or didn’t understand what to do with the information on their diabetes devices ... but we heard that a lot more frequently from the clinicians,” Tanenbaum told Endocrine Today. “They thought that that was a barrier for their patients. There might be some conversations that aren’t happening. We hope that if clinicians and patients can get on the same page about what the barriers really are — and they’re going to be different for each individual — they can do some troubleshooting together.”

‘Patient-driven’ care

As patient uptake increases for both pump therapy and CGM, Wong said, it is imperative that providers work with patients to become interpreters of their own data.

“The way for the provider not to be overwhelmed by data is to try, as hard as they can, to get patients able to understand their own data,” Wong said. “That’s my goal as a pediatric endocrinologist, and it’s also the role of the adult endocrinologist. We need to make this data more accessible and more actionable for the patient.”

Wong said pediatric providers should take opportunities to show parents and children, particularly preteens and teens, examples from their daily life where their data points to trouble areas. A volleyball tournament, for example, may require adjustments in insulin dosing, and data from a previous, similar event can show why.

“I can review the data all I want, but really, it’s the child who is going to grow up to be an adult with type 1 or type 2 diabetes who is going to need to know what to do with this data,” Wong said. “Our role is giving them the tools so that, hopefully, they can start doing this on their own.”

Garg agreed that educating patients on how to interpret their own data is key. Decision support systems, he said, should be in place to guide patients on the rate of change in glucose, based on overall time in range, and on how to adjust insulin dose.

“When the patients are initiated, the providers or educators can really educate the patients on how to interpret these data,” Garg said. “That’s the only way it is going to be used. I can tell you the majority of the physicians have zero time to interact with CGM data. It needs to be self-interpreted.

“This is a disease that, whether it’s type 1 or insulin-requiring type 2 diabetes, patients are living every second of the day,” Garg said. “Doctors are probably seeing them 1 hour a year. They shouldn’t be on the driver’s side at all. It should be all patient driven.” – by Regina Schaffer

• References:
• AADE. Principles and Recommendations Related to the Collection and Use of Patient Diabetes Management Data. Available at: www.diabeteseducator.org/docs/default-source/practice/practice-resources/white-papers_test/aade-health-information-technologies--final.pdf?sfvrsn=2. Accessed Aug. 15, 2017.
• T1D Exchange. 2013 annual State of Diabetes report. Available at: t1dexchange.org/pages/leading-type-1-diabetes-organizations-collaborate-to-improve-health-outcomes-and-access-to-therapies-and-technologies/. Accessed Aug. 15, 2017.
• Tanenbaum ML, et al. J Diabetes Sci Technol. 2017; doi:10.1177/1932296816688010.
• Tanenbaum ML, et al. Diabetes Care. 2017;doi:10.2337/dc16-1536.

• For more information:
• Timothy S. Bailey, MD, FACE, CPI, can be reached at the AMCR Institute, 625 W. Citracado Parkway, Suite 112, Escondido, CA 92025; email: tbailey@amcrinstitute.com.
• Satish K. Garg, MD, can be reached at the Barbara Davis Center for Diabetes, University of Colorado Denver, 1775 Aurora Court, Room M20-1323, Aurora, CO 80045; email: ssatish.garg@ucdenver.edu.
• Irl B. Hirsch, MD, can be reached at University of Washington Med Center – Roosevelt, 4245 Roosevelt Way NE, 3rd Floor, Box 354691, Seattle, WA 98105; email: ihirsch@u.washington.edu.
• Molly L. Tanenbaum, PhD, can be reached at Stanford University School of Medicine, Department of Pediatrics, 291 Campus Drive, Stanford, CA 94305; email: mollyt@stanford.edu.
• Jenise C. Wong, MD, PhD, can be reached at the University of California San Francisco Benioff Children’s Hospital, Pediatric Diabetes Clinic, 1500 Owens St., Suite 300, San Francisco, CA 94158; email: jenise.wong@ucsf.edu.

Disclosures: Bailey reports receiving consultant or speaking fees from Bayer AG, BD, Medtronic, Novo Nordisk and Sanofi, and receiving research support from Abbott, ACON Laboratories, Alere, Animas Corp., Bayer AG, BD, Bristol-Myers Squibb, Cebix, Dexcom, Eli Lilly and Company, GlaxoSmithKline, Halozyme Therapeutics, Insulet Corp., LifeScan, MannKind Corp., Medtronic, Merck, Orexigen Therapeutics, Sanofi and Tandem Diabetes Care. Garg reports serving on advisory boards for Dexcom, Eli Lilly, Lexicon, Mannkind, Medtronic, Merck, Roche and Sanofi, and receiving research grants through his institution from Animas, Dario, Dexcom, Eli Lilly, JDRF, Lexicon, Medtronic, Merck, NCI, NIDDK, Novo Nordisk, Sanofi and T1D Exchange. Hirsch reports receiving consultant fees from Abbott Diabetes Care, Intarcia and Roche Diagnostics. Wong reports serving on an advisory board for Tidepool. Tanenbaum reports no relevant financial disclosures.

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