Conversion of continuous infusion of regular insulin to subcutaneous glargine insulin for regulating blood glucose in patients receiving TPN: A method development study.

The main objective of this study is transitioning from regular insulin provided in the parenteral nutrition (PN) mixtures to subcutaneously administered insulin glargine in patients receiving PN. This study will be conducted under controlled conditions of a randomized clinical trial. Inclusion criteria: aged over 18 years; patients who are NPO for at least 7 days or more. Exclusion criteria: autoimmune diseases, HIV infection and sepsis; diabetes mellitus; pregnancy; on dialysis or GFR < 10 mL/min (due to the pharmacokinetics of insulin); any hypersensitivity to PN components or insulin glargine; receiving corticosteroids, catecholamines, or getting PO. The study population is 28 people. During the first phase of this study, glycemic control is done in a 24-hour infusion of regular insulin in dextrose solution. After completing the first phase patients are randomly allocated in a 1:1 ratio by permuted-block randomization method to either be converted to subcutaneously administered insulin glargine pen or kept on insulin regular in dextrose solution and continued for 3 more days. In the glargine group, glycemic control is performed with once daily subcutaneous injection of insulin glargine and there is no insulin regular in dextrose solution. If needed, insulin dose adjustment is performed based on the protocol toward placing in the target range of 110 to 180 ml/dL. Values of blood glucose before PN and the end of the study are recorded.

Tehran University of Medical Sciences (TUMS)