Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia
Open Access
- 21 March 2018
- journal article
- research article
- Published by American Diabetes Association in Diabetes Care
- Vol. 41 (5), 1001-1008
- https://doi.org/10.2337/dc17-1779
Abstract
OBJECTIVE Attaining glycemic targets without severe hypoglycemic events (SHEs) is a challenging treatment goal for patients with type 1 diabetes complicated by impaired awareness of hypoglycemia (IAH). The CIT Consortium Protocol 07 (CIT-07) trial showed islet transplantation to be an effective treatment for subjects with IAH and intractable SHEs. We evaluated health-related quality of life (HRQOL), functional health status, and health utility before and after pancreatic islet transplantation in CIT-07 trial participants. RESEARCH DESIGN AND METHODS Four surveys, the Diabetes Distress Scale (DDS), the Hypoglycemic Fear Survey (HFS), the Short Form 36 Health Survey (SF-36), and the EuroQoL 5 Dimensions (EQ-5D), were administered repeatedly before and after islet transplantation. Summary statistics and longitudinal modeling were used to describe changes in survey scores from baseline and to characterize change in relation to a minimally important difference (MID) threshold of half an SD. RESULTS Improvements in condition-specific HRQOL met the MID threshold. Reductions from baseline in the DDS total score and its four DDS subscales (all P ≤ 0.0013) and in the HFS total score and its two subscales (all P < 0.0001) were observed across all time points. Improvements were observed after both 1 and 2 years for the EQ-5D visual analog scale (both P < 0.0001). CONCLUSIONS In CIT-07, 87.5% of the subjects achieved the primary end point of freedom from SHE along with glycemic control (HbA1c 1c <53 mmol/mol) at 1 year post–initial islet transplantation. The same subjects reported consistent, statistically significant, and clinically meaningful improvements in condition-specific HRQOL as well as self-assessments of overall health.Funding Information
- NIAID (U01-AI-089317)
- NIAID (U01-AI-089316)
- NIAID (U01-AI-065191)
- NIDDK (U01-DK-085531)
- NIDDK (5U01-DK-070431-10)
- NIDDK (U01-DK-070431)
- NIDDK (U01-DK-070460)
- NIAID (U01-AI-065193)
- NIDDK (U01-DK-070430)
- NIAID (U01-AI-065192)
This publication has 40 references indexed in Scilit:
- Fear of hypoglycaemia in patients with type 1 diabetes: Do patients and diabetologists feel the same way?Diabetes & Metabolism, 2013
- When Is Diabetes Distress Clinically Meaningful?Diabetes Care, 2012
- Quality of Life Improves for Pediatric Patients After Total Pancreatectomy and Islet Autotransplant for Chronic PancreatitisClinical Gastroenterology and Hepatology, 2011
- Quality of life after islet transplantation: data from the GRAGIL 1 and 2 trialsDiabetic Medicine, 2009
- Improved Long-Term Health-Related Quality of Life After Islet TransplantationTransplantation, 2008
- Improved Metabolic Control and Quality of Life in Seven Patients With Type 1 Diabetes Following Islet After Kidney TransplantationTransplantation, 2008
- Quality of Life After Islet Transplant: Impact of the Number of Islet Infusions and Metabolic OutcomeTransplantation, 2007
- Quality of Life After Islet TransplantationAmerican Journal of Transplantation, 2006
- Reduced Fear of Hypoglycemia in Successful Islet TransplantationDiabetes Care, 2004
- EuroQol - a new facility for the measurement of health-related quality of lifeHealth Policy, 1990