Comparison of the use of insulin by injection under the skin versus insulin by injection directly into a vein, in patients suffering diabetes, who are hospitalized but not in critical conditions, and who are receiving food completely by introducing it in a vein (total parenteral nutrition)

Subcutaneous versus intravenous basal insulin in non-critical hospitalized diabetic patients receiving total parenteral nutrition

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003954-42-ES

Enrollment

320

Registered

2015-10-30

Start date

2016-01-27

Completion date

Unknown

Last updated

2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus (DM) is a group of metabolic disorders that causes high levels of blood glucose (hyperglycemia) which are persistent or chronic. DM presents epidemic proportions in most of the world. In Spain, the estimated prevalence of DM reaches 14% of the adult population. The prevalence of DM in the hospitals is also very high and is associated with increased mortality during hospitalization, longer hospital stays and higher costs. MedDRA version: 18.1 Level: LLT Classification code 1004

Interventions

Trade Name: Actrapid 100 IU/ml injectable solution Product Name: insulin (human) Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN HUMAN CAS Number: 11061-68-0 Current Sponsor c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adults (> 18 years). - Previously diagnosed with diabetes mellitus. - Hospitalized without intensive cares. - Having indication of total parenteral nutritional support (TPN, covering over 70% of the nutritional daily requirements via parenteral way of administration) and it is specified that it will be needed for a minimum of 5 days. - Read and signature of informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 320 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 320

Exclusion criteria

Exclusion criteria: Diabetes mellitus type 1, diabetes secondary to total pancreatectomy. - Patients in intensive care. - Patients who have been prescribed total parenteral nutrition in intensive cares more than 48 hours prior to admission for hospitalization. - Intradialytic parenteral nutrition. - Patients under 18 or pregnant women. - Patients with renal insufficiency stage 3 B (glomerular filtration rate <45 mL / min)

Design outcomes

Primary

Measure	Time frame
Main Objective: Analyze the degree of metabolic control achieved by a pattern of regular insulin in the stock of parenteral nutrition (PN) plus glargine subcutaneous insulin, compared to regular insulin in the stock of PN.;Secondary Objective: 1. Compare parameters of glycemic control during total parenteral nutrition (TPN) between the two guidelines: - Rapid glucose average. - Percentage of patients with average capillary blood glucose <180 mg/dL. - Glycemic variability. - Hypoglycemia. 2. Evaluate the average stay, complications and in-hospital mortality by insulin pattern and degree of metabolic control achieved. 3. Validate the utility of new glucose monitoring device Freestyle Free for management of hyperglycemia in diabetic patients with TPN. 4. Create a biobank of biological samples (blood) diabetes patients receiving TPN for further studies related to metabolism, inflammation, oxidation.;Primary end point(s): Efficacy endpoints: - Blood glucose - Interstitial glucose - Glycemic variability;Timepoint(s) of evaluation of this end point: From the first day of the TPN, every 6 hours, during 10 days.	—

Measure

Time frame

Main Objective: Analyze the degree of metabolic control achieved by a pattern of regular insulin in the stock of parenteral nutrition (PN) plus glargine subcutaneous insulin, compared to regular insulin in the stock of PN.;Secondary Objective: 1. Compare parameters of glycemic control during total parenteral nutrition (TPN) between the two guidelines: - Rapid glucose average. - Percentage of patients with average capillary blood glucose <180 mg/dL. - Glycemic variability. - Hypoglycemia. 2. Evaluate the average stay, complications and in-hospital mortality by insulin pattern and degree of metabolic control achieved. 3. Validate the utility of new glucose monitoring device Freestyle Free for management of hyperglycemia in diabetic patients with TPN. 4. Create a biobank of biological samples (blood) diabetes patients receiving TPN for further studies related to metabolism, inflammation, oxidation.;Primary end point(s): Efficacy endpoints: - Blood glucose - Interstitial glucose - Glycemic variability;Timepoint(s) of evaluation of this end point: From the first day of the TPN, every 6 hours, during 10 days.

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Secondary

Measure	Time frame
Secondary end point(s): Security endpoints: - Infections related with parenteral nutrition catheter - Metabolic complications - Liver complications - Adverse Events;Timepoint(s) of evaluation of this end point: Periodically	—

Countries

Spain

Contacts

Public ContactUnidad de Apoyo a Ensayos Clínicos

Fundación Pública Andaluza Progreso y Salud

gestionensayosclinicos.fps@juntadeandalucia.es34955040450

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026