Insulin in Total Parenteral Nutrition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Subcutaneous Versus Intravenous Basal Insulin in Non-critical Hospitalized Diabetic Patients That Receive Total Parenteral Nutrition

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Subcutaneous glargine insulin
* Drug: Regular insulin added to TPN bag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (>18 years) Previously diagnosed with diabetes mellitus. Hospitalized but without intensive cares. Have indication of total parenteral nutritional support (TPN, meaning the covering over 70% of the estimated daily requirements intravenously) for a minimum of 5 days. Signature of informed consent. Exclusion Criteria: Diabetes mellitus type 1, diabetes secondary to total pancreatectomy. Patients with intensive cares. Patients who have been prescribed TPN in intensive cares unity more than 48 hours before admission to hospitalization. Intradialytic parenteral nutrition. Patients under 18 or pregnant women. Patients with renal insufficiency stage 3 B (glomerular filtration rate < 45 mL / min).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glargine insulin<br>Single dose glargine insulin (basal component) + regular insulin within total parenteral nutrition (TPN) reservoir (prandial component). 50% of the total calculated dose of insulin is administered subcutaneously as single dose subcutaneous glargine insulin; remaining 50% of the total calculated dose of insulin is administered as regular insulin in the TPN reservoir. Interventions used: Intravenous glargine insulin, and regular insulin added to TPN bag | Drug: Subcutaneous glargine insulin<br>* Glargine insuline is an insulin analogue which has a prolonged duration of action. Insulin glargine is obtained by recombinant DNA technology in Escherichia coli.<br>* Other names: Abasaglar®;Drug: Regular insulin added to TPN bag<br>* Regular insulin is human insulin produced in Saccharomyces cerevisiae by recombinant DNA technology.<br>* Other names: Actrapid®;|
| Active Comparator: Regular insulin<br>Regular insulin added to TPN bag (basal + prandial component). The calculated total dose of insulin is administered as regular insulin in the TPN reservoir. Interventions used: Regular insulin added to TPN bag | Drug: Regular insulin added to TPN bag<br>* Regular insulin is human insulin produced in Saccharomyces cerevisiae by recombinant DNA technology.<br>* Other names: Actrapid®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal blood glucose value before starting TPN | Basal glucose value before starting TPN (in mg/dL). | Before starting total parenteral nutrition | 
| Periodical blood glucose | All blood glucose values (in mg/dL) every 6 hours during 15 days of TPN infusion. | 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. | 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. | 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. | 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 | 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 | Through study completion, an average of 15 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard deviation of blood glucose | Standard deviation of blood glucose (SD): Expressed in milligrams per deciliter (in mg/dL). | 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. | At day 15 of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total parenteral nutrition, glargine insulin, insulin