A Phase 4 interventional study of Subcutaneous glargine insulin and Regular insulin added to TPN bag in Diabetes Mellitus, sponsored by Fundación Pública Andaluza Progreso y Salud. Completed at 32 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-24.
Sponsored by Fundación Pública Andaluza Progreso y Salud · Phase 4, Interventional, and Screening
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.
Fundación Pública Andaluza Progreso y Salud is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Regular insulin added to TPN bag
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
Glargine insuline is an insulin analogue which has a prolonged duration of action. Insulin glargine is obtained by recombinant DNA technology in Escherichia coli.
Also known as: ATC code A10AE0, Lantus®, Abasaglar®
Regular insulin is human insulin produced in Saccharomyces cerevisiae by recombinant DNA technology.
Also known as: ATC code A10AB01, Actrapid®
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.
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
Infections related with catheter used in parenteral nutrition
Investigator asses the occurrence of infectious complications in parenteral nutrition catheter. For the evaluation of the infections, temperature is collected daily and patient will perform a blood test weekly. It will be suspected infectious complication for any sudden onset of fever (usually "peaks"), with no other apparent source of infection.
Time frame: At day 15 of treatment
Hypertriglyceridemia
A determination above this value will be considered a complication: Hypertriglyceridemia ≥500 mg/dL
Time frame: Every 6h during 15 days of treatment.
Hypernatremia
A determination above this value will be considered a complication: Hypernatremia \>150 mEq/L
Time frame: Every 6h during 15 days of treatment.
Hyponatremia
A determination below this value will be considered a complication: Hyponatremia \<135 mEq/L
Time frame: Every 6h during 15 days of treatment.
Hypokalemia
A determination below this value will be considered a complication: Hypokalemia \<3 mEq/L
Time frame: Every 6h during 15 days of treatment.
Hypomagnesemia
A determination below this value will be considered a complication: Hypomagnesemia \<1.2 mg/dL
Time frame: Every 6h during 15 days of treatment.
Hypophosphatemia
A determination below this value will be considered a complication: Hypophosphatemia \<2 mg/dL
Time frame: Every 6h during 15 days of treatment.
Hyperchloremia
A determination above this value will be considered a complication: Hyperchloremia \>120 mEq/L
Time frame: Every 6h during 15 days of treatment.
Hypocalcemia corrected calcium
A determination below this value will be considered a complication: Hypocalcemia corrected calcium \<8 mg/dL
Time frame: Every 6h during 15 days of treatment.
Alteration of liver function markers
Alteration of liver function markers is defined as an elevation twice higher than normal limits, according to each laboratory, of two of some of the following parameters (when previously normal): GGT, GOT, GPT, FA or total bilirubin, at least 7 days after initiating TPN.
Time frame: At day 7 and 15 of treatment
Adverse events
All adverse events (AEs) are recorded in the case report data since the moment when the patient signs the informed consent. These events will be defined following the organ classification database of MedDRA system.
Time frame: At day 15 of treatment
Plan to share: Yes
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Fundación Pública Andaluza Progreso y Salud