Table 2:

Identified Health Technology Assessments on Islet Transplantation for Patients with Type 1 Diabetes Mellitus

Author, Year	Search Dates	Inclusion Criteria	Outcomes of Interest	No. of Studies Included	Main Clinical Conclusions	AMSTAR Ratinga
IHE, 2013 (41)	2006–2011 (for grey literature)and 2000–2010 (for published literature)	Non-uremic T1DM patients with severe hypoglycemia, hypoglycemic unawareness, or unstable diabetes Uremic T1DM patients with end-stage renal disease IT versus intensive insulin therapy or PT Systematic review, meta-analysis, HTA (searched 2006–2011) RCT, non-RCT, cohort, case-control, case series (searched 2000–2010)	Clinical effectiveness Safety Cost-effectiveness Patient eligibility criteria for IT	6 observational comparative studies (with 8 publications) 13 case series (with 20 publications)	Observational comparative studies suggest IT associated with higher risk of procedure-related adverse events compared with intensive insulin therapy, but fewer compared with PT Insulin independence rates with IT are significantly lower than with PT, but with reduced insulin doses IT can maintain similar glycemic control to that of PT IT showed improvement in disease-specific HRQOL scores Definition of success of IT remains controversial IT should aim at reducing insulin dose and frequency of severe hypoglycemic events IT alternative treatment for small subgroup of patients with severe T1DM Role in long-term treatment of T1DM yet to be determined	10
MUHC, 2014 (Xie et al (42))	2008–November 25, 2013	IT for patients with T1DM Systematic review, HTA, economic evaluation	Clinical effectiveness Safety Cost-effectiveness Budget impact	1 HTA 1 systematic review 1 economic evaluation	IAK for patients with unstable T1DM can improve glycemic control and reduce hypoglycemia Insulin independence rates with IT lower than those with PT, but graft survival rates are similar Lower risk of procedural mortality or complications with IT than with PT Both IT and PT have high risk of severe adverse events associated with immunosuppression therapy Insufficient evidence that IT is equal or superior to PT to justify its routine use when PT is the procedure under consideration	4
CADTH, 2014 (rapid response) (43)	2011–November 12, 2014	Unstable or uncontrolled diabetes IT vs. insulin and/or other pharmaceutical therapy HTA, systematic review, meta-analysis, RCT, non-RCT, economic evaluation, guideline	Clinical effectiveness Cost-effectiveness	1 HTA 2 guidelines	Limited evidence IT is effective in maintaining insulin independence and associated with improved clinical outcomes for unstable T1DM Registry data suggest increase in insulin independence rates and decrease in adverse event risks in recent years compared with earlier years Rates of insulin independence for IT are lower than with PT	6

Abbreviations: AMSTAR, Assessment of Multiple Systematic Reviews; CADTH, Canadian Agency for Drugs and Technologies in Health; HRQOL, health-related quality of life; HTA, health technology assessment; IAK, islet-after-kidney transplantation; IHE, Institute for Health Economics; IT, islet transplantation; MUHC, McGill University Health Centre; PT, pancreas transplantation; RCT, randomized controlled trial; T1DM, type 1 diabetes mellitus.

^aScored out of 11.