Analyze the level of metabolic control achieved with a routine of regular insulin in the parenteral nutrition (PN) reservoir in addition to subcutaneous glargine insulin, versus only regular insulin in the PN reservoir.
A pattern of basal insulin (using subcutaneous insulin glargine and regulating the stock as prandial), plus regular subcutaneous insulin as rescue, applied to total parenteral nutrition (TPN) should be as effective (glycemic control, variability) and safe (hypoglycemia) as the usual (regular insulin inside the TPN reservoir and subcutaneous insulin as rescue) in patients with type 2 diabetes critics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
163
Glargine insuline is an insulin analogue which has a prolonged duration of action. Insulin glargine is obtained by recombinant DNA technology in Escherichia coli.
Regular insulin is human insulin produced in Saccharomyces cerevisiae by recombinant DNA technology.
Basal blood glucose value before starting TPN
Basal glucose value before starting TPN (in mg/dL).
Time frame: Before starting total parenteral nutrition
Periodical blood glucose
All blood glucose values (in mg/dL) every 6 hours during 15 days of TPN infusion.
Time frame: Every 6h during 15 days of treatment
Variation of average blood glucose compared with total dose of insulin
Variation of average glucose (in mg/dL) compared with total dose of insulin (in mL), in days 1, 5 and 15 of treatment.
Time frame: In days 1, 5 and 15 of treatment
Number of hypoglycaemia
Number of symptomatic and asymptomatic hypoglycaemia with blood glucose below 70 mg/dL during TPN treatment up to 15 days.
Time frame: During TPN treatment up to 15 days
Number of severe hypoglycaemia
Number of symptomatic and asymptomatic hypoglycaemia with blood glucose below 40 mg/dL during TPN treatment up to 15 days.
Time frame: During TPN treatment up to 15 days
Hypoglycemia blood glucose values
If the patient refers typical symptoms of hypoglycemia, a measure of blood glucose (in mg/mL) is immediately taken to check the level
Time frame: Through study completion, an average of 15 days.
Hypoglycemia symptoms
If blood glucose \<70 mg / dL, it is recorded whether or not the patient has symptoms consistent with hypoglycemia and how the episode terminates
Time frame: Through study completion, an average of 15 days.
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Standard deviation of blood glucose
Standard deviation of blood glucose (SD): Expressed in milligrams per deciliter (in mg/dL).
Time frame: At day 15 of treatment
Blood glucose coefficient of variation (CV)
Coefficient of variation (CV): Expressed as a percentage (%). The ratio of the standard deviation of the blood glucoses values (in mg/dL) and the average blood glucose (in mg/dL), multiplied by 100.
Time frame: At day 15 of treatment