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)

Phase 1

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: 18.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2015-003954-42-ES

Lead Sponsor: Fundación Pública Andaluza Progreso y Salud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 320

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

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)