Insulin in Total Parenteral Nutrition
- Conditions
- Diabetes Mellitus
- Interventions
- Drug: Regular insulin added to TPN bagDrug: Subcutaneous glargine insulin
- Registration Number
- NCT02706119
- Lead Sponsor
- Fundación Pública Andaluza Progreso y Salud
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Regular insulin 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 Glargine insulin Subcutaneous 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 Glargine insulin Regular insulin added to TPN bag 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
- Primary Outcome Measures
Name Time Method Basal blood glucose value before starting TPN Before starting total parenteral nutrition Basal glucose value before starting TPN (in mg/dL).
Periodical blood glucose 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 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 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 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 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 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 Outcome Measures
Name Time Method Standard deviation of blood glucose At day 15 of treatment Standard deviation of blood glucose (SD): Expressed in milligrams per deciliter (in mg/dL).
Blood glucose coefficient of variation (CV) At day 15 of treatment 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.
Trial Locations
- Locations (32)
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital Arquitecto Marcide-Naval
🇪🇸Ferrol, A Coruña, Spain
Hospital de Cabueñes
🇪🇸Gijón, Asturias, Spain
Hospital de Mérida
🇪🇸Mérida, Badajoz, Spain
Hospital General Mancha Centro
🇪🇸Alcázar de San Juan, Ciudad Real, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Infanta Cristina
🇪🇸Badajoz, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Universitario Nuestra Señora de la Candelaria
🇪🇸Tenerife, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario y Politécnico La Fe
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Universitario Severo Ochoa
🇪🇸Leganés, Madrid, Spain
Complejo Hospitalario Universitario de Albacete
🇪🇸Albacete, Spain
Hospital Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Complejo Asistencial Universitario de León
🇪🇸León, Spain
Hospital de Sant Joan Despi Moisès Broggi (Consorci Sanitari Integral)
🇪🇸Barcelona, Spain
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Universitario Principe de Asturias
🇪🇸Alcalá de Henares, Madrid, Spain
Hospital Son Llátzer
🇪🇸Palma de Mallorca, Baleares, Spain
Hospital Universitario de Fuenlabrada
🇪🇸Fuenlabrada, Madrid, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario Bellvitge
🇪🇸Barcelona, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
Hospital Universitario de Guadalajara
🇪🇸Guadalajara, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Regional Universitario de Málaga
🇪🇸Málaga, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain