medwireNews: The opening day of the 2017 American Diabetes Association 77th Scientific Sessions featured symposia on a broad range of topics including the stigma of diabetes, management of diabetic neuropathy, biomarkers of type 1 diabetes, and the role of the intestinal immune system in metabolic disease.
Technology brings clinic care closer to home
In one of the opening sessions, Laura Gandrud (Children’s Hospitals and Clinics of Minnesota, Minneapolis, USA) and Aylin Altan (Optum Labs, Eden Prairie, Minnesota, USA) discussed the results of a randomized pilot study of intensive remote glucose monitoring among children with type 1 diabetes. Gandrud explained the rationale behind the study, while Altan focused on the data.
Gandrud said that the current model for glucose monitoring is under pressure; her patients make an average of 3.6 clinic visits per year with 20% travelling long distances each time, which is difficult for families. And all clinical decisions are based on recall and retrospective review of what the patients tell them.
Gandrud believes that powerful data from Bluetooth-enabled devices, cloud-based data application platforms, and patient self-management applications, combined with data analytics and care processes, “could efficiently improve outcomes.” She said: “It was this belief that motivated the study that we are doing.”
The 60 patients randomly assigned to receive intensive remote therapy (IRT) had quarterly visits with their physician and uploaded data from their insulin pump and activity tracker on a weekly basis. The data were reviewed by providers, a therapy summary was emailed to the family, and there was regular contact between care providers and patients or their families, including text reminders to upload data.
The 57 patients in the usual care group also uploaded pump and activity tracker data but there was no clinician review or additional contact with these families outside of regular clinic visits.
Altan reported that glycated hemoglobin (HbA1c) fell by 0.34% in the IRT group after 6 months of the intervention, a finding she described as “not huge but not negligible”. By comparison, HbA1c fell by just 0.05% in the usual care group over the same period.
However, she noted that the greatest impact occurred among patients aged 13–17 years receiving IRT; in this group HbA1c fell by 0.5%.
The decrease in HbA1c was dependent on the number of weeks that the child uploaded the data, indicating that “engagement in the program was extremely important to produce the effect we were looking for,” Altan said. Specifically, HbA1c decreased by 0.7% in IRT patients with more than 24 weeks of uploaded data, compared with 0.08% in IRT patients with fewer than 20 weeks of data.
In addition, she reported that the benefits of the intervention were maintained for at least 3 months after it ended in children aged 8–12 years, but there was a gradual increase in HbA1c among those aged 13–17 years suggesting that these patients “may need support for continued successful self-management.”
Gandrud concluded: “With connected devices, data analytics will transform clinical processes and we will achieve better outcomes more efficiently and will be able to scale them more effectively.”
However, she stressed that “solutions must be individualized,” saying that “future clinicians will lead digital command centers.”
An overview of sulfonylureas
Moving away from insulin, Kamlesh Khunti from the University of Leicester, UK, delivered a comprehensive summary of sulfonylureas to a packed lecture hall. He talked about the history of the drugs; how they compare in randomized controlled trials and observational studies in terms of efficacy, durability, and weight gain; their impact on cardiovascular mortality; mechanism of action; and practical considerations.
He said there is extensive experience in the use of sulfonylureas – the first drugs were marketed in the 1950s – and the risks and benefits are therefore well understood. Indeed, meta analyses and trials such as ADOPT and ADVANCE have shown that sulfonylureas have good efficacy when used as monotherapy or as an add-on to metformin, and the response is durable, with no significant associated weight gain.
However, Khunti admitted that there is currently “huge controversy” surrounding sulfonylureas and the risk for cardiovascular disease and mortality.
One trial suggested that patients on first-line sulfonylurea therapy had a 32% higher risk for heart failure hospitalization or cardiovascular death than those on metformin. But Khunti pointed out that the trial design did not reflect clinical practice, as sulfonylureas are not generally used as a first-line therapy. Furthermore, the protective effect of metformin may also have impacted the results.
Many more studies showed no increased cardiovascular risk with sulfonylurea therapy or between the different types of sulfonylurea, although Khunti noted that the risk was lowest with glicazide, followed by glimepiride and glibenclamide.
In terms of practical considerations, he said that the drugs have got to be affordable, and sulfonylureas are the most cost-effective second-line treatment for diabetes.
However, he added: “We have great drugs but we are not using them in a timely manner […] we are waiting far too long to intensify patients.
“What we should be doing is getting these patients on whatever therapy we can afford, bringing and keeping HbA1c down for as long as possible with whatever therapy is available, which will lead to better outcomes for these patients in the longer term,” he concluded.
Diabetes care in older adults
There were four presentations in the session on diabetes care in older adults, and the take-home message was that hypoglycemia is more common in older patients with diabetes but cannot always be predicted using mean HbA1c level.
Graydon Meneilly (University of British Columbia, Vancouver, Canada) opened with a discussion on clinical care issues. He said that Hb1Ac targets in older patients with diabetes should be based on functional status and comorbidity to avoid overtreatment in frail patients whose life expectancy may be limited.
The Canadian Diabetes Association and American Diabetes Association guidelines recommend HbA1c levels below 7.0% or 7.5%, respectively, for healthy older patients and below 8.5% or 8.0% for frail older patients.
In spite of this, one study showed that 50–60% of patients over the age of 65 years with complex poor health had an HbA1c level below 7.0%, which Meneilly said was “too tight,” and highlights why “we are more worried about overtreatment [in this field] than undertreatment.”
Another important point he made was that many older patients with diabetes fail to recognize the symptoms of hypoglycemia. Therefore educating patients and their families is one way to prevent hypoglycemia in this group. Using agents, including newer insulins, that are associated with a lower frequency of hypoglycemia will also help.
Sue Kirkman (University of North Carolina School of Medicine, Chapel Hill, USA) presented data on behalf of Medha Munshi (Joslin Diabetes Center, Boston, Massachusetts, USA) about the harms of more aggressive treatment in older adults with diabetes. She agreed with Meneilly that it is important to “think about appropriate goal setting […] not just the glycemic goal but the glycemic strategy,” as data show that HbA1c alone does not give an accurate picture of the harms occurring due to repeated hypoglycemic episodes.
Indeed, a study among Munshi’s patients, who were over 70 years of age with an HbA1c level above 8.0%, revealed that 65% had multiple undetected hypoglycemias. One reason for this is that comorbidites commonly seen in older adults with diabetes, including dizziness, can mimic hypoglycemia symptoms, Kirkman said.
Munshi’s data also showed that simplifying insulin regimens or converting patients to oral agents decreased the number of hypoglycemic episodes while simultaneously reducing HbA1c.
Jeffrey Halter (University of Michigan, Ann Arbor, USA) talked about the impact of cardiovascular disease in older adults with diabetes and how it can be prevented.
He said that weight loss and exercise have “massive” benefits in reducing cardiovascular risk, but studies are hard to do in these patients. Similarly, it is known that statins effectively reduce cholesterol but again there are no specific studies in older patients with diabetes. Lowering blood pressure and having good glycemic control are also effective, along with stopping smoking. But Halter pointed out that despite the known benefits, “not every patient can deal with all of this.”
He therefore suggested another approach: Targeting ageing itself. A review of data showed that metformin has the potential to be used as a drug that enhances longevity and delays age-related disease, a theory that he hopes will be tested in the TEAM proof of concept clinical trial.
Finally, Ruth Weinstick (State University of New York Upstate Medical University, Syracuse, USA) focused on hypoglycemia in older patients with type 1 diabetes, for whom there is far less data than for those with type 2 diabetes.
She questioned whether raising HbA1c to prevent serious hypoglycemia is sufficient in these patients, and concluded that it is not. Data from the Type 1 Diabetes Exchange project showed that patients with a severe hypoglycemic episode in the previous 12 months had very similar HbA1c levels to those who had no hypoglycemia in the past 3 years, at 7.8% versus 7.7%, while mean glucose levels were identical, at 175 mg/dL in both groups.
However, more patients with severe hypoglycemia had glucose variability above 75%, at 38% versus 12% among those with no hypoglycemia and they were more likely to delay reporting hypoglycemic symptoms until their glucose level was below 50 mg/dL. The cases also had more cognitive impairment and a greater fear of hypoglycemia.
To address the glucose variability in these patients Weinstick believes that, despite a lack of randomized controlled trails in this population, “most if not all type 1 adults would benefit from professional CGM [continuous glucose monitoring].”
But she points out that there would need to be some usability modifications such as louder alarms and larger fonts to make them suitable for older patients.
By Laura Cowen
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