IV Insulin Protocol in Diabetes and Renal Transplantation

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Diabetes; Hyperglycemia; Kidney Transplantation

Treatments: Drug: insulin; Drug: NPH Insulin or glargine insulin and aspartame insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT00609986

ADA 7-07-CR-22

HR #17383

Details and patient eligibility

About

Purpose: The purpose of this study is to provide tight blood sugar control using insulin given through the veins at the time of kidney transplantation and up to 3 days after surgery. After release from the hospital, the patient will control blood sugar with subcutaneous insulin injections or pills. With this approach, outcomes should improve for diabetic transplant patients such as longer life of the new kidney, fewer hospital readmissions, decreased associated infections, and other advantages.

Hypothesis: It is hypothesized that intensive glycemic control will lead to better clinical and biochemical outcomes and improved long-term graft survival.

Full description

Research Design: A randomized control trial comparing intensive intravenous insulin (IVI) for use in the hospital followed by intensive subcutaneous (sc) insulin use for in-patient and out-patient glycemic control will be conducted.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age and greater,
• Diabetes diagnosis (Type 1 and Type 2, awaiting a living or cadaveric renal transplant, renal transplant candidates admitted to MUSC medical center for a donor kidney, FBG >100 mg/dL per admission screening labs, random BG >120mg/dL per admission screening labs, and
• Willing and able to provide informed consent

Exclusion criteria

• History of an active GI bleed in the previous 3 mos,
• Scheduled to receive a simultaneous pancreas transplant,
• History of a functioning pancreatic transplant,
• Patient currently managed on an insulin pump,
• Unable or unwilling to provide informed consent, and
• Unable to commit to the study protocol including the outpatient follow-up phase of care

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Intensive

Experimental group

Description:

The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.

Treatment:

Drug: insulin

Control

Active Comparator group

Description:

The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.

Treatment:

Drug: NPH Insulin or glargine insulin and aspartame insulin