Abstract

Evidence exists on demographics and costs of diabetes patients; however, data is limited on type 2 diabetes (T2DM) patients receiving a basal-bolus insulin regimen administered as multiple daily injections (>3 injections/day). The objective of the systematic literature review was to summarize the clinical and economic burden of T2DM patients using multiple daily injections (MDI) of insulin. A systematic literature review was conducted utilizing PubMed, the Cochrane library, and clinical trials.gov. Articles were included if they reported on clinical and/or economic burden of T2DM MDI patients. Articles were published after 1996, written in English. Key exclusions included: T1DM or mixed T1DM/T2DM populations (>10% T1DM); focus on non-insulin drugs or insulin pumps and studies enrolling <20 patients. Primary searches yielded 744 unique records, 330 full text articles were screened, and 66 met inclusion criteria. Fifty eight studies were primary observational (N=22) or interventional (N=36). Patients on insulin receiving >3 injections/day ranged from 23-36%. Mean demographic ranges included: age 49-73 years, weight 68-121kg, diabetes duration 6-17 years, and insulin duration 1-8 years. Comorbidities reported included hypertension (62-95%) and dyslipidemia (30-95%). Complications reported included neuropathy (29-59%) and retinopathy (19-22%). Total daily insulin doses ranged from 40-155 units/day; 0.7-2.4 U/kg/day. Mean baseline HbA1c ranged from 7.6-10.1% in observational and 6.9-10.3% in interventional studies. Patients achieving HbA1c <7% ranged from 8-16% in observational and 5-84% in interventional studies. Mean endpoint HbA1c ranged from 8.1-8.8% in observational; 6.4-8.6% in interventional studies. Total annual healthcare costs ranged from $20,553-$42,020; diabetes-related costs ranged from $8,180-$14,248. The findings of the systematic literature review suggest that T2DM patients on MDI had multiple comorbidities, microvascular complications, and substantial healthcare costs.

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