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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

Authors

  • Gad Segal MD,

    Deputy Head, Corresponding author
    1. Internal Medicine ‘T’, Tel Aviv Medical Center, Sackler School of Medicine, Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel
    • Correspondence: Gad Segal, Internal Medicine ‘T’, Tel Aviv Medical Center, Sackler School of Medicine, Faculty of Medicine, Tel-Aviv University, Tel Aviv 55451, Israel. Email: dr.segal@medidactic.com

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  • Eli Karniel MD,

    Investigator
    1. Internal Medicine ‘T’, Tel Aviv Medical Center, Sackler School of Medicine, Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel
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  • Ahmed Mahagna RN,

    Investigator
    1. Internal Medicine ‘T’, Tel Aviv Medical Center, Tel Aviv University Nursing Faculty, Tel Aviv, Israel
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  • Fadi Kaa'dan RN,

    Investigator
    1. Internal Medicine ‘T’, Tel Aviv Medical Center, Tel Aviv University Nursing Faculty, Tel Aviv, Israel
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  • Zehava Levi RN,

    Investigator
    1. Internal Medicine ‘T’, Tel Aviv Medical Center, Tel Aviv University Nursing Faculty, Tel Aviv, Israel
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  • Chaya Balik RN PhD

    Principal Investigator
    1. Seinborn Academic Nursing School, Tel Aviv University Nursing Faculty, Tel Aviv, Israel
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  • Eli Karniel, protocol design, safety monitoring, patients' consent, results analysis, manuscript proof reading; Ahmed Mahagna, protocol design, patients' monitoring, staff training, manuscript proof reading; Fadi Kaa'dan, protocol design, patients' monitoring, staff training, manuscript proof reading; Zehava Levi, staff training, manuscript proof reading; Chaya Balik, protocol writing, results analysis, manuscript writing.

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.

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