Guideline:
Pancreas transplantation in type 1 diabetes
Bibliographic Source(s)
- Robertson P Davis C Larsen J Stratta R Sutherland DE. Pancreas transplantation in type 1 diabetes. Diabetes Care 2004 Jan;27(Suppl 1):S105. [1 reference] PubMed
Guideline Status
This is the current release of the guideline.
The guideline was originally approved in November 1999.
American Diabetes Association (ADA) position statements are reissued annually.
Guideline Category
Management
Treatment
Intended Users
Health Plans
Physicians
Guideline Objective(s)
To review the safety efficacy and indications for pancreas and islet cell transplantation for patients with diabetes mellitus
Target Population
- Adults with diabetes mellitus with imminent or established end-stage renal disease who have had or plan to have a kidney transplant
- Adults with diabetes mellitus who meet the following criteria for pancreas-only transplantation: 1) a history of frequent acute severe metabolic complications requiring medical attention 2) clinical and emotional problems associated with exogenous insulin therapy that are so severe as to be incapacitating and 3) consistent failure of insulin-based management to prevent acute complications
Interventions and Practices Considered
- Pancreas after kidney transplant (PAK)
- Pancreas transplant alone (PTA)
- Simultaneous pancreas and kidney transplant (SPK)
- Pancreatic islet cell transplant
Major Outcomes Considered
- 1- and 3-year patient and graft survival
- Metabolic results (i.e. independence from exogenous insulin therapy blood glucose concentrations HbA1c glucose counterregulation)
- Effects on the chronic complications of diabetes
Methods Used to Collect/Select Evidence
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
Not stated
Number of Source Documents
Not stated
Methods Used to Assess the Quality and Strength of the Evidence
Not stated
Rating Scheme for the Strength of the Evidence
Not applicable
Methods Used to Analyze the Evidence
Review
Description of the Methods Used to Analyze the Evidence
Not stated
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
Not stated
Rating Scheme for the Strength of the Recommendations
Not applicable
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation
This paper was peer-reviewed and approved by the Professional Practice Committee and the Executive Committee.
Major Recommendations
- Pancreas transplantation should be considered an acceptable therapeutic alternative to continued insulin therapy in diabetic patients with imminent or established end-stage renal disease who have had or plan to have a kidney transplant because the successful addition of a pancreas does not jeopardize patient survival may improve kidney survival and will restore normal glycemia. Such patients also must meet the medical indications and criteria for kidney transplantation and not have excessive surgical risk for the dual transplant procedure. Medicare and other third-party payers of medical care should include coverage for pancreas transplant procedures meeting these criteria. The pancreas transplant may be done simultaneous with or subsequent to a kidney transplant. Pancreas graft survival is better when done simultaneously with a kidney transplant.
- In the absence of indications for kidney transplantation pancreas transplantation should only be considered a therapy in patients who exhibit these three criteria: 1) a history of frequent acute and severe metabolic complications (hypoglycemia hyperglycemia ketoacidosis) requiring medical attention 2) clinical and emotional problems with exogenous insulin therapy that are so severe as to be incapacitating and 3) consistent failure of insulin-based management to prevent acute complications. Program guidelines for ensuring an objective multidisciplinary evaluation of the patient's condition and eligibility for transplantation should be established and followed. Third-party payer coverage is appropriate only where such guidelines and procedures exist.
- Pancreatic islet cell transplants hold significant potential advantages over whole-gland transplants. However at this time islet cell transplantation is an experimental procedure also requiring systemic immunosuppression and should be performed only within the setting of controlled research studies.
Clinical Algorithm(s)
None provided
Type of Evidence supporting the Recommendations
The type of supporting evidence is not specifically stated for each recommendation.
Potential Benefits
Successful pancreatic transplantation may result in:
- Independence from exogenous insulin therapy normal blood glucose concentrations and normal or near-normal HbA1c.
- Improved quality of life primarily due to elimination of daily insulin injections and frequent daily blood glucose measurements
- Reduced episodes of acute complications experienced by patients with type I diabetes (e.g. hypoglycemia hyperglycemia)
- Partial reversal of the long-term renal and neural complications
- Prolonged life expectancy of diabetic patients with autonomic insufficiency
Potential Harms
Risks associated with pancreatic transplantation include clinical complications caused by the surgery and by chronic immunosuppressive drugs as well as death.
- Surgical complications: Perioperative complications leading to relaparotomy occur in approximately 30% of patients and include intra-abdominal infections and abscess vascular graft thrombosis anastomotic leak and duodenal stump leak.
- Side effects associated with life-long immunosuppressive therapy: The combination of immunosuppressive agents most frequently used (e.g. cyclosporine azathioprine and prednisone) have numerous and varied significant adverse effects including nephrotoxicity infection hypertension and gingival hyperplasia.
- Mortality risk: The mortality rate 1 and 3 years after pancreas transplant alone (PTA) simultaneous pancreas and kidney transplant (SPK) or pancreas after kidney transplant (PAK) is approximately 7%. The mortality rate 1 year after the much less invasive procedure of pancreatic islet transplantation is 5%. Thus it seems likely that the mortality rates are related more to chronic diabetes than to pancreas transplantation itself.
Qualifying Statements
Evidence is only one component of clinical decision-making. Clinicians care for patients not populations; guidelines must always be interpreted with the needs of the individual patient in mind. Individual circumstances such as comorbid and coexisting diseases age education disability and above all patient's values and preferences must also be considered and may lead to different treatment targets and strategies. Also conventional evidence hierarchies such as the one adapted by American Diabetes Association may miss some nuances that are important in diabetes care.
Description of Implementation Strategy
An implementation strategy was not provided.
IOM Care Need
Living with Illness
IOM Domain
Effectiveness
Bibliographic Source(s)
- Robertson P Davis C Larsen J Stratta R Sutherland DE. Pancreas transplantation in type 1 diabetes. Diabetes Care 2004 Jan;27(Suppl 1):S105. [1 reference] PubMed
Adaptation
Not applicable: The guideline was not adapted from another source.
Source(s) of Funding
The American Diabetes Association (ADA) received an unrestricted educational grant from LifeScan Inc. a Johnson and Johnson Company to support publication of the 2004 Diabetes Care Supplement.
Guideline Committee
Professional Practice Committee
Composition of Group that Authored the Guideline
Authors of Position Statement Initial Draft: R. Paul Robertson MD: Connie Davis MD; Jennifer Larsen MD; Robert Stratta MD; David E.R. Sutherland MD
Financial Disclosures/Conflicts of Interest
Not stated
Guideline Status
This is the current release of the guideline.
The guideline was originally approved in November 1999.
American Diabetes Association (ADA) position statements are reissued annually.
Guideline Availability
Electronic copies: Available from the American Diabetes Association (ADA) Web site.
Print copies: Available from American Diabetes Association 1701 North Beauregard Street Alexandria VA 22311.
Availability of Companion Documents
The recommendations in this paper are based on the evidence reviewed in the following publication:
- Robertson RP Davis C Larsen J Stratta R Sutherland DER: Pancreas and islet transplantation for patients with diabetes (Technical Review). Diabetes Care 2000;23:112-6.
Print copies: Available from the American Diabetes Association (ADA) 1701 North Beauregard Street Alexandria VA 22311.
Patient Resources
None available
NGC STATUS
This summary was completed by ECRI on November 1 1998. The information was verified by the guideline developer on December 15 1998. This summary was updated by ECRI on April 1 2001 January 29 2002 April 21 2003 and April 1 2004.
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