Addressing the Burden of Multiple Daily Insulin Injections in Type 2 Diabetes with Insulin Pump Technology: A Narrative Review.

The growing prevalence of type 2 diabetes (T2D) remains a leading health concern in the US. Despite new medications and technologies, glycemic control in this population remains suboptimal, which increases the risk of poor outcomes, increased healthcare resource utilization, and associated costs. This article reviews the clinical and economic impacts of suboptimal glycemic control in patients on basal-bolus insulin or multiple daily injections (MDI) and discusses how new technologies, such as tubeless insulin delivery devices, referred to as "patch pumps", have the potential to improve outcomes in patients with T2D.

Pen needle use patterns in an insured population with diabetes: US retrospective claims analysis.

BACKGROUND: People with diabetes who inject insulin with pen devices may reuse the pen needles (PNs), a practice that can cause PN tip deformity, breakage, and contamination, and that is associated with lipohypertrophy and injection-related pain. OBJECTIVE: This retrospective study aimed to estimate the extent of PN reuse among people with diabetes in two insured populations in the United States. METHODS: Using claims data for Commercial Fully Insured (CFI) and Medicare Advantage (MA) populations from 1-Oct-2018 to 31-Dec-2022, we identified adults with type 1 or type 2 diabetes (T1D/T2D) who had ≥1 claim for PNs and ≥2 claims for insulin from 1-Jan-2019 to 31-Dec-2021, with continuous medical/pharmacy eligibility for 3 months before first claim and 1 year after (follow-up). Those receiving hospice or palliative care or using mail-order prescriptions were excluded. We compared actual annual fill rate of PNs with expected fill rate (assuming single use) according to prescribed insulin regimen. Whether the annual actual-to-expected ratio for PN numbers equaled 1 was evaluated using sign tests with 2-sided p-values. RESULTS: Median annual actual-to-expected ratios ranged from 0.41 (T1D basal+prandial cohort) to 0.82 (T2D basal cohort; all p<0.001) in the CFI population (N=10,854), and from 0.55 (TID basal+prandial) to 1.10 (T2D basal and basal+prandial; p=0.382 to <0.001) in the MA population (N=32,495); medians were 0.34 and 0.55 for four expected T2D basal+prandial injections/day in CFI and MA populations, respectively (p<0.001). Annual actual-to-expected ratios were <1 for 62% and 47% of CFI and MA populations, respectively. An estimated 2-27% and 0-17%, respectively, depending on insulin regimen, had inadequate supplies of PNs suggesting that PNs could have been used ≥5 times. CONCLUSIONS: These findings highlight the need for educating people with diabetes about reasons for avoiding PN reuse and the key role that pharmacists can play in providing this information and adequate supplies of PNs.

Medication Prescribing for Type 2 Diabetes in the US Long-Term Care Setting: Observational Study.

OBJECTIVES: To characterize prescribing of glucose-lowering medication annually and to quantify the annual frequency of hypoglycemia among residents in long-term care (LTC) facilities with type 2 diabetes mellitus (T2DM). DESIGN: Serial cross-sectional study using a deidentified real-world database comprising electronic health records from LTC facilities. SETTING AND PARTICIPANTS: Individuals eligible for this study were ≥65 years old with T2DM and recorded stay of ≥100 days at an LTC facility in the United States in any of 5 study years (2016-2020), excluding individuals receiving palliative or hospice care. METHODS: Drug orders (prescriptions) for glucose-lowering medications for each LTC resident with T2DM in each calendar year were summarized by administration route (oral or injectable) and by drug class as ever-prescribed (ie, multiple prescriptions were included once), overall and stratified by age subgroup, <3 vs ≥3 comorbidities, and obesity status. We calculated the annual percentage of patients ever prescribed glucose-lowering medication each year, overall and by medication category, who experienced ≥1 hypoglycemic events. RESULTS: Among 71,200 to 120,861 LTC residents with T2DM included each year from 2016 to 2020, 68% to 73% (depending on the year) were prescribed ≥1 glucose-lowering medications, among them oral agents for 59% to 62% and injectable agents for 70% to 71%. Metformin was the most commonly prescribed oral agent, followed by sulfonylureas and dipeptidyl peptidase 4 inhibitors; basal plus prandial insulin was the most commonly prescribed injectable regimen. Prescribing patterns remained relatively consistent from 2016 to 2020, both overall and by patient subgroup. During each study year, 35% of LTC residents with T2DM experienced level 1 hypoglycemia (glucose ≥54 to <70 mg/dL), including 10% to 12% of those prescribed only oral agents and ≥44% of those prescribed injectable agents. Overall, 24% to 25% experienced level 2 hypoglycemia (glucose concentration <54 mg/dL). CONCLUSIONS AND IMPLICATIONS: Study findings suggest that opportunities exist for improving diabetes management for LTC residents with T2DM.

Leveraging Partnerships to Reduce Insulin Needlestick Injuries: Nurse-Led System-Wide Quality Improvement Project.

BACKGROUND: Percutaneous injuries from needlesticks are a major occupational hazard for nurses. LOCAL PROBLEM: Reducing subcutaneous insulin-related needlestick injuries was part of a nurse-led comprehensive sharps injury-reduction program at an integrated, not-for-profit health system. METHODS: The incident rate of needlestick injuries was compared between 1 year before and 1 year after introducing this quality improvement project. INTERVENTIONS: A system-wide educational program instituting changes in subcutaneous insulin administration practices was combined with supply chain standardization using a single type of safety-engineered insulin syringe. RESULTS: The average monthly incidence of needlestick injuries per 10 000 subcutaneous insulin injections fell significantly from year to year (incidence rate ratio, 0.49; 95% CI, 0.30-0.80; Poisson regression P = .004). One-year cost savings for supplies totaled $3500; additional annual median savings were $24 875 (2019 US dollars) in estimated costs of needlestick injuries averted. CONCLUSIONS: The effectiveness of this multifaceted project provides a practical template to reduce subcutaneous insulin-related needlestick injuries.

Hypoglycemia upon hospital admission from long-term care: health care resource use.

OBJECTIVES: Residents with diabetes in long-term care (LTC) settings often have recognized risk factors for developing hypoglycemia, including advanced age, dementia, and polypharmacy; however, data regarding hypoglycemia in LTC and associated hospitalizations are lacking. Our aim was to describe health care resource use and costs for patients with diabetes and hypoglycemia upon hospital admission. STUDY DESIGN: Retrospective, descriptive study using a US hospital billing database, October 2015 through September 2019. METHODS: Eligible patients were those 18 years and older with type 1 or 2 diabetes who (1) were hospitalized with hypoglycemia upon admission from LTC or from home and (2) received insulin during hospitalization. We described the percentages of patients admitted from LTC or from home with hypoglycemia and their characteristics, length of hospitalization, and hospital costs (2019 US$). RESULTS: Of 106,602 patients with diabetes admitted from LTC and 4,315,571 from home, 6609 (6%) and 182,756 (4%), respectively, presented with hypoglycemia on hospital admission. Mean ages of patients admitted with hypoglycemia from LTC and home were 73 and 66 years, respectively. The percentages of patients in LTC and home cohorts with dementia were 34% and 12%, respectively; with renal disease, 60% and 52%; and with type 2 diabetes, 95% and 89%. Mean hospital stays were 8.0 days for patients admitted from LTC and 6.7 days for those admitted from home; mean total hospital costs were $19,800 and $16,800, respectively. CONCLUSIONS: These findings highlight the importance of providing optimal diabetes management for patients in LTC settings to prevent hypoglycemia and potential hospitalizations and costs.

Treatment Intensification With Insulin Pumps and Other Technologies in Patients With Type 2 Diabetes: Results of a Physician Survey in the United States.

An online survey was conducted to assess the perspectives and use of diabetes technologies by a sample of U.S. primary care physicians (PCPs) and endocrinologists to optimize intensive insulin therapy in patients with type 2 diabetes. Overall, endocrinologists reported using diabetes technologies more frequently than PCPs for patients with type 2 diabetes requiring basal-bolus insulin therapy. PCPs and endocrinologists who were highly focused on diabetes management with insulin therapy reported using insulin delivery devices (insulin pumps and wearable tube-free patches) when patients are not achieving their A1C target while taking basal plus three or more prandial injections of insulin daily.

Persistence with Basal-Bolus Insulin Therapy in Patients with Type 2 Diabetes Mellitus and Effect on Clinical and Economic Outcomes: A Retrospective Claims Database Study.

BACKGROUND: Persistence with multiple daily insulin injections (MDI) may be challenging for patients with type 2 diabetes (T2DM). However, limited information is available regarding the effect of persistence with MDI on outcomes. OBJECTIVE: To evaluate persistence with basal and bolus insulin therapy and assess its relationship with clinical and economic outcomes in a real-world setting. METHODS: This retrospective matched cohort study used 2012-2015 data from multiple U.S. commercial health plans (IBM MarketScan). Patients with T2DM aged 18-64 years with ≥ 2 basal and ≥ 2 bolus insulin claims during a 12-month period were eligible for inclusion if they had 18 months of continuous health plan enrollment (6-month baseline and 12-month post-index). Persistence during 12 months post-index was defined using 2 methods: (a) method 1, ≤ 90-day gaps in both basal and bolus insulin claims and (b) method 2, ≥ 1 basal and ≥ 1 bolus insulin claim every quarter (every 90 days) for 4 consecutive quarters after index bolus claim. Propensity score matching was used to match persistent and nonpersistent method 2 cohorts. Mean per-patient all-cause and diabetes-related medical costs (2015 U.S. dollars, excluding outpatient drugs) and health care resource use (HCRU) were calculated. For patients with hemoglobin A1c (A1c) values during baseline and post-index months 10-12, treatment success was defined as (a) A1c decrease from baseline of ≥ 1% and/or (b) baseline A1c ≥ 7% with post-index A1c < 7%. Baseline characteristics of matched cohorts were compared using standardized mean differences (SMDs). Outcome variables were compared using t-tests, chi-square tests, and generalized linear models. RESULTS: Characteristics of 12,882 eligible patients and 12-month persistence rates were similar as defined by method 1 (22.4%) and method 2 (21.1%). After matching, the method 2 cohorts included 2,723 and 8,169 persistent and nonpersistent patients, respectively, with well-balanced baseline characteristics (mean age 53 years; 58% men; all SMDs < 0.1). All-cause annual medical costs were lower for the persistent cohort (mean $13,499 vs. $17,362; P < 0.0001), as were annual diabetes-related costs (mean $6,392 vs. $8,376; P < 0.0001). In persistent versus nonpersistent cohorts, 11% versus 15% of patients, respectively, experienced ≥ 1 hospitalization; 21% versus 24%, respectively, had ≥ 1 ED visit; 9% versus 12%, respectively, experienced ≥ 1 diabetes-related hospitalization; and 13% versus 15%, respectively, had ≥ 1 diabetes-related ED visit (P ≤ 0.005 for all). Mean baseline A1c was similar in persistent and nonpersistent cohorts (9.7% vs. 9.6%, respectively; P = 0.63). Persistence with MDI was associated with greater mean reduction in A1c (-1.3% vs. -0.8%, respectively; P = 0.006) and greater percentages of patients achieving treatment success (55% vs. 39%, respectively, for nonpersistent; P = 0.009). CONCLUSIONS: Poor persistence with basal-bolus insulin therapy over 12 months of follow-up was prevalent and was associated with greater medical costs, greater HCRU, and poorer glycemic control than for patients who were persistent. Interventions are needed to improve persistence with insulin therapy and aid patients with T2DM to achieve glycemic control. DISCLOSURES: Funding for this study was provided by Becton, Dickinson and Company (BD). All authors except Edelman are employees and stockholders of BD. Edelman reports board membership at Senseonics and participation in advisory board/speakers bureau at Lilly USA, MannKind, Novo Nordisk, Sanofi-Aventis U.S., Merck, and AstraZeneca, all unrelated to this study. A poster for this study was presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2018; April 23-26, 2018; Boston MA.

Clinical and Economic Outcomes of Patients with Type 2 Diabetes on Multiple Daily Injections of Basal-bolus Insulin (MDI) Therapy: A Retrospective Cohort Study.

PURPOSE: Therapy for patients with type 2 diabetes (T2DM) not achieving hemoglobin (Hb) A1c targets may progress from an oral antidiabetic drug (OAD) to added basal insulin and then to multiple daily injections of basal-bolus insulin (MDI); however, the relative clinical and economic burden experienced by patients prescribed MDI for T2DM is not well quantified. The intent of this work was to describe direct medical costs, health care resource utilization, and glycemic control in patients with T2DM exposed to MDI in a clinical practice setting. METHODS: This retrospective cohort study used administrative claims data (2012-2015, United States) from patients aged 18 to 64 years with T2DM prescribed OAD, basal insulin, or MDI therapy. Eligible patients had continuous enrollment from ≥6 months before to 12 months after the date of the index prescription drug claim. Patients eligible for inclusion in the MDI cohort had ≥2 pharmacy claims each for basal and bolus insulin from the index date through the postindex period. Glycemic control, defined as an HbA1c value of <7% during the last 9 postindex months, was assessed in a subset of patients with HbA1c data available from that period. Descriptive analyses were performed. FINDINGS: We identified 225,135 patients with T2DM and claims for an OAD (n = 188,230), basal insulin (n = 23,724), or MDI (n = 13,181). The mean age was 51 or 52 years in each cohort; 54% to 59% of patients in each cohort were men. The mean Charlson comorbidity index scores were 0.8, 1.4, and 1.8, respectively; the percentages of patients with obesity and diabetes-related complications were greatest in the MDI cohort compared with OAD and basal insulin cohorts. The mean direct medical costs (all-cause; year-2015 US $) were $9368 in the OAD cohort, $14,420 in the basal insulin cohort, and $25,624 in the MDI cohort; diabetes-related costs were $3396, $7285, and $13,538. In the OAD, basal insulin, and MDI cohorts, 7%, 9%, and 14% of patients had ≥1 hospitalization, and 17%, 20%, and 24% had ≥1 emergency department visit, while 5%, 7%, and 11% had ≥1 diabetes-related hospitalization, and 8%, 11%, and 15% had ≥1 diabetes-related emergency department visit. Glycemic control was found in 64%, 22%, and 15% of patients in the OAD, basal insulin, and MDI cohorts. IMPLICATIONS: These findings suggest that patients prescribed MDI therapy for T2DM have greater disease burden, experience greater medical costs and health care resource utilization, and exhibit poorer glycemic control than do patients treated with OAD or basal insulin therapy.