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## Complete Summary

#### GUIDELINE TITLE

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](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14693941)

#### 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.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Type 1 diabetes mellitus

#### GUIDELINE CATEGORY

Management\
Treatment

#### CLINICAL SPECIALTY

Endocrinology\
Internal Medicine

#### 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

1.  Pancreas after kidney transplant (PAK)

2.  Pancreas transplant alone (PTA)

3.  Simultaneous pancreas and kidney transplant (SPK)

4.  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, HbA~1c~, glucose
    counterregulation)

-   Effects on the chronic complications of diabetes

### METHODOLOGY

#### 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.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

1.  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.

2.  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.

3.  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

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is not specifically stated for each
recommendation.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Successful pancreatic transplantation may result in:

-   Independence from exogenous insulin therapy, normal blood glucose
    concentrations, and normal or near-normal HbA~1c~.

-   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

#### 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.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### 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](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14693941)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

1999 Nov (republished 2004 Jan)

#### GUIDELINE DEVELOPER(S)

American Diabetes Association - Professional Association

#### 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](http://care.diabetesjournals.org/cgi/content/full/27/suppl_1/s105).

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.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is
copyrighted by the American Diabetes Association (ADA).

For information on guideline reproduction, please contact Alison Favors,
Manager, Rights and Permissions by e-mail at <permissions@diabetes.org>.

For information about the use of the guidelines, please contact the
Clinical Affairs Department at (703) 549-1500 ext. 1692.

### DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008