CHICAGO – Patients with type 1 diabetes who had impaired awareness of hypoglycemia and were provided with education and support, had equal biochemical outcomes whether they were on insulin pump therapy or daily injections.
Researchers also found that the outcomes were equal for patients whether they were on conventional or real-time glucose monitoring.
Impaired awareness of hypoglycemia, or IAH, affects roughly 20% of adults with type 1 diabetes. Also, severe hypoglycemia is six times more likely in these adults, said Dr. Stuart A. Little of Newcastle upon Tyne, England, who presented the results of Hypo COMPaSS, a 24-week, randomized controlled trial of 96 participants, at the annual scientific sessions of the American Diabetes Association.
"Sometimes patients with impaired awareness say that they don’t even feel it, and they think it’s okay," said Marjorie Cypress, Ph.D., the 2013 president-elect of ADA’s health care and education committee. "They need to learn that it’s not okay, that they’re not getting those warning signs, but they’re losing glucose from their brain."
Most of the participants in the trial were women (63%), their mean age was 49 years, their diabetes duration was about 29 years, and their mean HbA1c level was 66 mmol/mol, or about 8.2%.
Dr. Little and his colleagues randomized the 96 participants to a multiple daily injection (MDI) group (50 patients) and an insulin pump therapy (CSII) group (46). In the MDI group, 24 patients did not have real-time (RT) continuous glucose monitoring, and 26 did. And in the CSII group, 24 patients had no RT, and 22 did.
The primary endpoint of the study was the difference in 24-week Gold score, with an 80% power to detect a Gold score difference of 1.1 on a 7-point Likert scale.
Secondary endpoints included overall glycemic control and patient-reported outcomes.
All patients received equal support and had a treatment goal of rigorous avoidance of biochemical hypoglycemia without relaxation of overall hemoglobin A1c. They all had Gold scores of at least 4, indicating IAH.
Within 4 weeks, the patients’ biochemical hypoglycemia was reduced significantly, from 3.7% to 1.7% of the time, from 53 minutes/day to under half an hour. The reduction was maintained throughout the study.
The median Gold score also showed a statistically significant reduction by week 24 among all participants, dropping from 5 at baseline to 4 at the end of the study period.
There was also a dramatic reduction in severe hypoglycemic events, said Dr. Little. While 92% of the patients were affected by the condition the year before the study, and 77% were affected 6 months before the trial, only 19% were affected during the trial.
Fear of hypoglycemia was significantly reduced and treatment satisfaction improved among all participants. The mean HbA1c did not change throughout the study among the participants.
When the investigators compared the MDI and CSII groups, the Gold score and severe hypoglycemia were not significantly different, nor were the HbA1c levels or insulin units. And although the fear of hypoglycemia did not differ significantly between the two groups, the treatment satisfaction was significantly higher in the CSII group.
Comparing the patients based on real-time glucose monitoring or self-monitoring showed no statistically significant difference in Gold score, severe hypoglycemia, HbA1c levels, or insulin units. There were also no significant differences in fear of hypoglycemia and treatment satisfaction.
"The bottom line is, if you give people education about hypoglycemia, they do better. We’ve seen this before in other studies. Teach people, and they can avoid hypoglycemia," said Dr. Cypress.
Dr. Little and Dr. Cypress had no disclosures.
nmiller@frontlinemedcom.com
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