Improved health-related quality of life in a phase 3 islet transplantation trial in type 1 diabetes complicated by severe hypoglycemia

Eric D. Foster, Nancy D. Bridges, Irene D. Feurer, Thomas L. Eggerman, Lawrence G. Hunsicker, Rodolfo Alejandro

Research output: Contribution to journalArticle

15 Citations (Scopus)

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 usedtodescribe changesinsurvey 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 selfassessments of overall health.

Original languageEnglish (US)
Pages (from-to)1001-1008
Number of pages8
JournalDiabetes Care
Volume41
Issue number5
DOIs
StatePublished - May 1 2018

Fingerprint

Islets of Langerhans Transplantation
Type 1 Diabetes Mellitus
Hypoglycemia
Hypoglycemic Agents
Quality of Life
Clinical Protocols
Fear
Health
Health Surveys
Visual Analog Scale
Health Status
Research Design
Therapeutics
Surveys and Questionnaires

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

Cite this

Improved health-related quality of life in a phase 3 islet transplantation trial in type 1 diabetes complicated by severe hypoglycemia. / Foster, Eric D.; Bridges, Nancy D.; Feurer, Irene D.; Eggerman, Thomas L.; Hunsicker, Lawrence G.; Alejandro, Rodolfo.

In: Diabetes Care, Vol. 41, No. 5, 01.05.2018, p. 1001-1008.

Research output: Contribution to journalArticle

Foster, Eric D. ; Bridges, Nancy D. ; Feurer, Irene D. ; Eggerman, Thomas L. ; Hunsicker, Lawrence G. ; Alejandro, Rodolfo. / Improved health-related quality of life in a phase 3 islet transplantation trial in type 1 diabetes complicated by severe hypoglycemia. In: Diabetes Care. 2018 ; Vol. 41, No. 5. pp. 1001-1008.
@article{3fc3a99064d643c381b9e19f68c54c03,
title = "Improved health-related quality of life in a phase 3 islet transplantation trial in type 1 diabetes complicated by severe hypoglycemia",
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 usedtodescribe changesinsurvey 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 selfassessments of overall health.",
author = "Foster, {Eric D.} and Bridges, {Nancy D.} and Feurer, {Irene D.} and Eggerman, {Thomas L.} and Hunsicker, {Lawrence G.} and Rodolfo Alejandro",
year = "2018",
month = "5",
day = "1",
doi = "10.2337/dc17-1779/-/DC1",
language = "English (US)",
volume = "41",
pages = "1001--1008",
journal = "Diabetes Care",
issn = "1935-5548",
publisher = "American Diabetes Association Inc.",
number = "5",

}

TY - JOUR

T1 - Improved health-related quality of life in a phase 3 islet transplantation trial in type 1 diabetes complicated by severe hypoglycemia

AU - Foster, Eric D.

AU - Bridges, Nancy D.

AU - Feurer, Irene D.

AU - Eggerman, Thomas L.

AU - Hunsicker, Lawrence G.

AU - Alejandro, Rodolfo

PY - 2018/5/1

Y1 - 2018/5/1

N2 - 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 usedtodescribe changesinsurvey 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 selfassessments of overall health.

AB - 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 usedtodescribe changesinsurvey 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 selfassessments of overall health.

UR - http://www.scopus.com/inward/record.url?scp=85045298814&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85045298814&partnerID=8YFLogxK

U2 - 10.2337/dc17-1779/-/DC1

DO - 10.2337/dc17-1779/-/DC1

M3 - Article

VL - 41

SP - 1001

EP - 1008

JO - Diabetes Care

JF - Diabetes Care

SN - 1935-5548

IS - 5

ER -