NEW YORK (Reuters Health) – In people with type 1 diabetes complicated by severe hypoglycemia, islet transplantation is associated with improved health-related quality of life (HRQOL), according to new findings.
In the phase 3 Clinical Islet Transplantation Consortium Protocol 07 (CIT-07) trial, 42 of 48 patients (87.5%) achieved the primary endpoint of an HbA1c level below 7.0% (53 mmol/mol) at day 365 after the initial islet transplantation and freedom from severe hypoglycemic events from day 28 to day 365 after the initial islet transplantation.
In the new study, online March 21 in Diabetes Care, Dr. Eric D. Foster from the University of Iowa, in Iowa city, and colleagues evaluated the impact of pancreatic islet transplantation on HRQOL, functional health and health utility in CIT-07 participants.
Mean Diabetes Distress Scale (DDS) total scores and each of the four subscales improved significantly from baseline to days 75, 365 and 730 after the initial islet transplantation, indicating less diabetes-related distress. The total score and subscales of emotional burden and regimen-related distress exceeded the threshold for a minimally important difference.
Hypoglycemia Fear Survey (HFS) total scores and hypoglycemic-avoidance behavior and worry-about-hypoglycemia subscores showed similar improvements, and by day 730, most subjects indicated having no worries about hypoglycemia.
The physical component summary (PCS) and mental component summary (MCS) scores and all eight scales of the SF-36 Health Survey showed improvements over time.
HRQOL tended to be worse among patients with primary-endpoint failure posttransplantation, but there were no statistically significant differences.
“These patient-reported outcomes corroborate the clinical importance of the objective benefits of islet transplantation already documented in the CIT-07,” the researchers conclude.
Dr. Pratik Choudhary from King’s College London, U.K., who has studied islet transplantation, told Reuters Health by email, “The magnitude of the impact on quality of life is staggering and suggests that the pay-off in terms of immunosuppression is worthwhile from a patient-reported outcomes perspective.”
“A number of people feel that unless islet transplantation delivers complete ‘cure’ and freedom from insulin, it is not worthwhile,” said Dr. Choudhary, who was not involved in the study. “It is clear that if selected according to established indications, the patients feel very differently, and even though more than 50% were on insulin, there were still significant gains in terms of glucose control, hypoglycemia avoidance, and HRQOL/DDS.”
Dr. Foster did not respond to a request for comments.
SOURCE: https://bit.ly/2HxxxNz
Diabetes Care 2018.
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