Regular insulin added to total parenteral nutrition vs subcutaneous glargine in non-critically ill diabetic inpatients, a multicenter randomized clinical trial: INSUPAR trial

Autor: Juan José López-Gómez, Carmen Arraiza, Jose Abuin, María José Tapia, Juan Parra, E. Cáncer, Natalia Pérez-Ferre, Ana Zugasti, Carmen Aragón, Julia Álvarez, Sara Garcia, Irene Bretón, Josefina Olivares, Katherine García-Malpartida, Luis Miguel Luengo-Pérez, Mercedes Ferrer, Jose Manuel García-Almeida, Cristina Tejera, Ángel L. Abad, Sandra Herranz, Álvaro García-Manzanares, Rafael López, María J. Ocón, Sara Torrejón, Gabriel Olveira, María R. Alhambra, Pilar Serrano-Aguayo, Jorge D. Martín
Rok vydání: 2020
Předmět:
0301 basic medicine
Male
Diabetes
Glargine insulin
Insulin regimen
Non-critically ill patient
TPN
endocrine system diseases
medicine.medical_treatment
Glargine insulin
Insulin Glargine
Type 2 diabetes
Critical Care and Intensive Care Medicine
Gastroenterology
law.invention
0302 clinical medicine
Randomized controlled trial
law
Insulina
Insulin
Prospective Studies
Insulin regimen
Nutrition and Dietetics
Diabetis
Diabetes
Non-critically ill patient
Combined Modality Therapy
Treatment Outcome
Female
Parenteral Nutrition
Total
medicine.drug
medicine.medical_specialty
Injections
Subcutaneous
030209 endocrinology & metabolism
Hypoglycemia
TPN
03 medical and health sciences
Internal medicine
Diabetes mellitus
medicine
Humans
Hypoglycemic Agents
Aged
030109 nutrition & dietetics
business.industry
Insulin glargine
nutritional and metabolic diseases
medicine.disease
Parenteral nutrition
Diabetes Mellitus
Type 2
Spain
Regular insulin
business
Zdroj: Dipòsit Digital de la UB
Universidad de Barcelona
CLINICAL NUTRITION
r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe
instname
ISSN: 0261-5614
Popis: Summary Background There is no established insulin regimen in T2DM patients receiving parenteral nutrition. Aims To compare the effectiveness (metabolic control) and safety of two insulin regimens in patients with diabetes receiving TPN. Design Prospective, open-label, multicenter, clinical trial on adult inpatients with type 2 diabetes on a non-critical setting with indication for TPN. Patients were randomized on one of these two regimens: 100% of RI on TPN or 50% of Regular insulin added to TPN bag and 50% subcutaneous GI. Data were analyzed according to intention-to-treat principle. Results 81 patients were on RI and 80 on GI. No differences were observed in neither average total daily dose of insulin, programmed or correction, nor in capillary mean blood glucose during TPN infusion (165.3 ± 35.4 in RI vs 172.5 ± 43.6 mg/dL in GI; p = 0.25). Mean capillary glucose was significantly lower in the GI group within two days after TPN interruption (160.3 ± 45.1 in RI vs 141.7 ± 43.8 mg/dL in GI; p = 0.024). The percentage of capillary glucose above 180 mg/dL was similar in both groups. The rate of capillary glucose ≤70 mg/dL, the number of hypoglycemic episodes per 100 days of TPN, and the percentage of patients with non-severe hypoglycemia were significantly higher on GI group. No severe hypoglycemia was detected. No differences were observed in length of stay, infectious complications, or hospital mortality. Conclusion Effectiveness of both regimens was similar. GI group achieved better metabolic control after TPN interruption but non-severe hypoglycemia rate was higher in the GI group. Clinical trial registry This trial is registered at clinicaltrials.gov as NCT02706119 .
Databáze: OpenAIRE
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