Insulin in Total Parenteral Nutrition (INSUPAR)

Fundación Pública Andaluza Progreso y Salud

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: Regular insulin added to TPN bag; Drug: Subcutaneous glargine insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT02706119

FPS-INSUPAR-2015-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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163 participants in 2 patient groups

Glargine insulin

Experimental group

Description:

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

Treatment:

Drug: Subcutaneous glargine insulin

Drug: Regular insulin added to TPN bag

Regular insulin

Active Comparator group

Description:

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

Treatment:

Drug: Regular insulin added to TPN bag