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Diabetes Care. 2018 May;41(5):1001-1008. doi: 10.2337/dc17-1779. Epub 2018 Mar 21.

Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia.

Author information

1
Clinical Trials Statistical and Data Management Center, Department of Biostatistics, University of Iowa, Iowa City, IA eric-foster@uiowa.edu.
2
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.
3
Departments of Surgery and Biostatistics, Vanderbilt University Medical Center, and Vanderbilt Transplant Center, Nashville, TN.
4
National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.
5
Clinical Trials Statistical and Data Management Center, Department of Biostatistics, University of Iowa, Iowa City, IA.
6
Diabetes Research Institute, Miller School of Medicine, University of Miami, Miami, FL.

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 <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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00434811.

PMID:
29563196
PMCID:
PMC5911786
DOI:
10.2337/dc17-1779
[Indexed for MEDLINE]
Free PMC Article

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