NEW ORLEANS — A program that combines in-person and online training significantly reduced impaired hypoglycemia awareness and also decreased hypoglycemia-related stress and episodes of severe hypoglycemia, researchers announced at the American Diabetes Association (ADA) 2016 Scientific Sessions on June 12.
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"HypoAware" was designed by researchers at VU University Medical Center, the University of Amsterdam, the Netherlands. It is a "retooling" of Blood Glucose Awareness Training (BGAT), traditionally delivered in six to eight weekly in-person workshops. The Dutch researchers shortened the program to three workshop-type group sessions of 2.5 hours each and created two online modules, for a program that lasts 4 weeks.
"We aimed to make it brief, light, and attractive," said Frank J Snoek, PhD, chair of the department of medical psychology at VU University Medical Center.
The program delivered promising results in a pilot study, so the researchers conducted a cluster-randomized controlled trial at eight outpatient centers. Patients with both type 1 and type 2 diabetes were randomized to either care as usual or usual care plus HypoAware.
At 6 months after the training, HbA1c was unchanged, but episodes of severe hypoglycemia had been reduced by 35% to 37% in the intervention group. Impaired hypoglycemia awareness was decreased by 62%, and hypoglycemia-related stress was reduced by 20% to 30%, said Dr Snoek, who presented his data here.
"I think we can be really pleased with the outcomes of this very brief intervention," he told attendees. Dr Snoek said that while it was not completely straightforward to contrast HypoAware with results seen with BGAT, HypoAware "compares reasonably well."
The educational pathway — and psychological components of disease management — identified by BGAT were confirmed with HypoAware, he noted.
"It's very much about understanding your body, it's about awareness, it's about understanding your own risky behaviors, as well as communicating with your environment."
Asked to comment, Danielle M Hessler, MD, assistant professor of family community medicine, at the University of California, San Francisco School of Medicine, called the reduction in hypoglycemia and increased awareness of symptoms "very powerful."
It "was a very nice intervention that shows this hybrid of leveraging some technology but also interfacing with the patient at the same time," Dr Hessler told
She said it would be useful to find out more about the revisions the Dutch researchers made to BGAT and how it might be integrated with training in the United States.
Number Needed to Treat Is Less Than One
In the trial, patients at four clinics were randomized to receive HypoAware, and those at four other clinics received usual care. The mean age of patients was 52, and two-thirds were female.
Of the patients, 121 had type 1 diabetes and 14 had type 2. The mean disease duration was 28 years, and 104 patients had experienced episodes of impaired hypoglycemia awareness.
Forty-seven patients (34%) said they were very worried about hypoglycemia.
The researchers followed up with patients at 2, 4, and 6 months after the study began and estimated rate ratios (RR) and odds ratios (OR) with 95% confidence intervals (CI).
Intention-to-treat analyses were corrected for baseline outcomes, diabetes duration, treatment, HbA1c, and episodes of severe hypoglycemia in the preceding 2 years.
The relative risk of episodes of severe hypoglycemia (defined as requiring help from others) without medical intervention for those getting HypoAware was 0.65 (95% CI, 0.37–1.15; P = .139).
For episodes that required medical interference, the RR was 0.63 (95% CI, 0.19–2.15; P = .462). For impaired hypoglycemia awareness, the RR was 0.38 (95% CI, 0.15–0.95; P = .038).
"If you were to translate into numbers needed to treat, to prevent one episode you'd need to expose 0.7 patients to our intervention," said Dr Snoek.
The study did have some limitations, he said, including that the fact that it had relatively mild inclusion criteria and a short duration of follow-up. The researchers will soon be examining 12-month data to see whether the findings hold for that longer duration, he noted..
American Diabetes Association 2016 Scientific Sessions; June 12, 2016; New Orleans, Louisiana. Abstract 285-OR/285