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Efficacy and safety of patient-led versus physician-led titration of basal insulin in patients with uncontrolled type 2 diabetes: a meta-analysis of randomized controlled trials
  1. Marco Castellana1,
  2. Filippo Procino1,
  3. Rodolfo Sardone1,
  4. Pierpaolo Trimboli2,3,
  5. Gianluigi Giannelli4
  1. 1Population Health Unit, National Institute of Gastroenterology "Saverio de Bellis", Research Hospital, Castellana Grotte, Italy
  2. 2Clinic of Endocrinology and Diabetology, Lugano and Mendrisio Regional Hospital, Ente Ospedaliero Cantonale, Lugano, Switzerland
  3. 3Faculty of Biomedical Sciences, Università della Svizzera Italiana (USI), Lugano, Switzerland
  4. 4Scientific Direction, National Institute of Gastroenterology "Saverio de Bellis", Research Hospital, Castellana Grotte, Italy
  1. Correspondence to Dr Marco Castellana; mcastellana01{at}


Introduction Insulin is the most effective antihyperglycemic treatment and basal insulin is the preferred initial formulation in patients with type 2 diabetes. However, its effects are dose-dependent, so adequate titration is necessary to reach targets. We performed a meta-analysis to compare the efficacy and safety of patient-led versus physician-led titration of basal insulin in patients with uncontrolled type 2 diabetes.

Research design and methods Four databases were searched from database inception through March 2020. Randomized controlled studies with at least 12 weeks of follow-up of patients with type 2 diabetes allocated to patient-led versus physician-led titration of basal insulin were selected. Data on glycemic endpoints (hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), hypoglycemia) and other outcomes (insulin dose, body weight, patient-reported outcomes, adverse events, rescue medication, discontinuation) were extracted. Data were pooled using a random-effects model.

Results Six studies evaluating 12 409 patients were finally included. Compared with the physician-led performance, patient-led titration was associated with a statistically significant higher basal insulin dose (+6 IU/day), leading to benefits on HbA1c (−0.1%) and FPG (−5 mg/dL), despite a higher risk of any level hypoglycemia (relative risk=1.1) and a slight increase in body weight (+0.2 kg). No difference was found for the other outcomes.

Conclusions The present study showed that patient-led titration of basal insulin was not inferior to physician-led titration in patients with uncontrolled type 2 diabetes. Therefore, diabetes self-management education and support programs on basal insulin should be widely adopted in clinical practice and patients provided with tools to self-adjust their dose when necessary.

  • insulin
  • diabetes mellitus, type 2
  • meta-analysis

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  • Contributors MC conceived the meta-analysis. MC and FP developed the search strategy and provided statistical expertise. MC drafted the manuscript. All authors contributed to the development of the selection criteria, the risk of bias assessment strategy and data extraction criteria. All authors read, provided feedback, and approved the final manuscript. MC is the guarantor and takes responsibility for the content of the article.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval This meta-analysis was in accordance with the principles of the Declaration of Helsinki. Analyses were performed on data extracted from published papers.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement The data sets generated and/or analyzed during the current study are not publicly available but are available from the corresponding author on reasonable request.

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