Journal article
Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia
Diabetes care, Vol.41(5), pp.1001-1008
05/2018
DOI: 10.2337/dc17-1779
PMCID: PMC5911786
PMID: 29563196
Abstract
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.
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.
Improvements in condition-specific HRQOL met the MID threshold. Reductions from baseline in the DDS total score and its four DDS subscales (all
≤ 0.0013) and in the HFS total score and its two subscales (all
< 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
< 0.0001).
In CIT-07, 87.5% of the subjects achieved the primary end point of freedom from SHE along with glycemic control (HbA
<7% [<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.
Details
- Title: Subtitle
- Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia
- Creators
- Eric D Foster - University of IowaNancy D Bridges - National Institute of Allergy and Infectious DiseasesIrene D Feurer - Vanderbilt University Medical CenterThomas L Eggerman - National Institute of Diabetes and Digestive and Kidney DiseasesLawrence G Hunsicker - University of IowaRodolfo Alejandro - University of MiamiClinical Islet Transplantation Consortium
- Resource Type
- Journal article
- Publication Details
- Diabetes care, Vol.41(5), pp.1001-1008
- DOI
- 10.2337/dc17-1779
- PMID
- 29563196
- PMCID
- PMC5911786
- ISSN
- 0149-5992
- eISSN
- 1935-5548
- Grant note
- UL1 TR000150 / NCATS NIH HHS U01 AI089317 / NIAID NIH HHS UL1 RR025741 / NCRR NIH HHS UL1 TR000454 / NCATS NIH HHS U01 AI065193 / NIAID NIH HHS U01 DK070430 / NIDDK NIH HHS M01 RR000400 / NCRR NIH HHS UL1 TR000050 / NCATS NIH HHS UL1 TR000114 / NCATS NIH HHS U01 DK070431 / NIDDK NIH HHS U01 AI065192 / NIAID NIH HHS M01 RR000040 / NCRR NIH HHS U01 DK070460 / NIDDK NIH HHS UL1 TR000004 / NCATS NIH HHS U01 DK085531 / NIDDK NIH HHS U01 AI065191 / NIAID NIH HHS UL1 TR000460 / NCATS NIH HHS U01 AI089316 / NIAID NIH HHS UL1 TR000003 / NCATS NIH HHS
- Language
- English
- Date published
- 05/2018
- Academic Unit
- Biostatistics; Nephrology; Internal Medicine
- Record Identifier
- 9984364394902771
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