title: A nurse-guided, basal-prandial insulin treatment protocol for achieving glycaemic control of hospitalized, non-critically ill diabetes patients, is non-inferior to physician-guided therapy: A pivotal, nurse-empowerment study.
abstract: Basal-prandial insulin is established for glycaemic control for hospitalized, type 2 diabetes patients. Empowering nurses to guide such protocols could be advantageous.The study aims to comparatively assess the efficacy and safety of glycaemic control by a nurse-guided protocol with physician-guided therapy. It also aims to assess the impact of empowerment on the nurses' sense of competence. This is a prospective, controlled, randomized, single-blinded study. Validated protocol utilizing basal-prandial insulin was used. Glycaemic control was the primary efficacy outcome, whereas hypoglycaemia and laboratory parameters were followed for safety. Assessment of nurses' psychological empowerment was done. One hundred fifty-eight treatment days of 53 patients were included. Patients were randomized to either study group (n = 27) or control group (n = 26). Glycaemia deviation from liberal range (60-300 mg/dL) was 7.4% of days for nurse-guided, basal-prandial insulin treatment protocol (NGP) and 7.84% for physician-guided therapy (PGT), P = 0.901. Rate of glycaemia deviation from the strict range (100-180 mg/dL) was 49.76% for NGP and 47.38% for PGT, P = 0.703. Mean range of daily deviation was similar (77.05 mg/dL for NGP and 76.04 mg/dL for PGT, P = 0.93). There were no significant differences in safety parameters. An empowerment questionnaire showed tendency for increased nurses' sense of competence. Nurse-guided protocol is non-inferior to physician-guided treatment in efficacy and safety parameters. Nurses' sense of competence was positively influenced.
authors.affiliation: Internal Medicine 'T', Tel Aviv Medical Center, Sackler School of Medicine, Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Gad
authors.initials: G
authors.lastname: Segal
authors.affiliation: Internal Medicine 'T', Tel Aviv Medical Center, Sackler School of Medicine, Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Eli
authors.initials: E
authors.lastname: Karniel
authors.affiliation: Internal Medicine 'T', Tel Aviv Medical Center, Tel Aviv University Nursing Faculty, Tel Aviv, Israel.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Mahagna
authors.affiliation: Internal Medicine 'T', Tel Aviv Medical Center, Tel Aviv University Nursing Faculty, Tel Aviv, Israel.
authors.forename: Fadi
authors.initials: F
authors.lastname: Kaa'dan
authors.affiliation: Internal Medicine 'T', Tel Aviv Medical Center, Tel Aviv University Nursing Faculty, Tel Aviv, Israel.
authors.forename: Zehava
authors.initials: Z
authors.lastname: Levi
authors.affiliation: Seinborn Academic Nursing School, Tel Aviv University Nursing Faculty, Tel Aviv, Israel.
authors.forename: Chaya
authors.initials: C
authors.lastname: Balik
mesh_terms: D000368:Aged; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D011209:Power, Psychological; D057184:Practice Patterns, Nurses'; D011446:Prospective Studies; D012649:Self Concept; D016037:Single-Blind Method
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin
keywords: diabetes; empowerment; glycaemia control; internal medicine