Subcutaneous Versus Intravenous Basal Insulin in Non-critical Hospitalized Diabetic Patients That Receive Total Parenteral Nutrition
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 163
- Locations
- 32
- Primary Endpoint
- Basal blood glucose value before starting TPN
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Glargine insulin
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
Intervention: Subcutaneous glargine insulin (Drug)
Glargine insulin
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
Intervention: Regular insulin added to TPN bag (Drug)
Regular insulin
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
Intervention: Regular insulin added to TPN bag (Drug)
Outcomes
Primary Outcomes
Basal blood glucose value before starting TPN
Time Frame: Before starting total parenteral nutrition
Basal glucose value before starting TPN (in mg/dL).
Periodical blood glucose
Time Frame: Every 6h during 15 days of treatment
All blood glucose values (in mg/dL) every 6 hours during 15 days of TPN infusion.
Variation of average blood glucose compared with total dose of insulin
Time Frame: In days 1, 5 and 15 of treatment
Variation of average glucose (in mg/dL) compared with total dose of insulin (in mL), in days 1, 5 and 15 of treatment.
Number of hypoglycaemia
Time Frame: During TPN treatment up to 15 days
Number of symptomatic and asymptomatic hypoglycaemia with blood glucose below 70 mg/dL during TPN treatment up to 15 days.
Number of severe hypoglycaemia
Time Frame: During TPN treatment up to 15 days
Number of symptomatic and asymptomatic hypoglycaemia with blood glucose below 40 mg/dL during TPN treatment up to 15 days.
Hypoglycemia blood glucose values
Time Frame: Through study completion, an average of 15 days.
If the patient refers typical symptoms of hypoglycemia, a measure of blood glucose (in mg/mL) is immediately taken to check the level
Hypoglycemia symptoms
Time Frame: Through study completion, an average of 15 days.
If blood glucose \<70 mg / dL, it is recorded whether or not the patient has symptoms consistent with hypoglycemia and how the episode terminates
Secondary Outcomes
- Standard deviation of blood glucose(At day 15 of treatment)
- Blood glucose coefficient of variation (CV)(At day 15 of treatment)