Dissertations and Theses

Date of Degree

9-1-2018

Document Type

Dissertation

Degree Name

Doctor of Public Health (DPH)

Department

Health Policy and Management

Advisor(s)

WILLIAM T. GALLO

Committee Members

WILLIAM T. GALLO

MARIANNE FAHS

ALEXIS POZEN

Subject Categories

Epidemiology | Health Services Research | Pharmacoeconomics and Pharmaceutical Economics | Public Health

Keywords

Lipohypertrophy, China

Abstract

Background

Diabetes is a global epidemic and with an aging population accompanied by rapid urbanization China ranks highest in disease prevalence and associated burden. Independent of diabetes type, insulin is an eventual and costly requirement for disease management. The consequences of insulin administration however are poorly understood. Lipohypertrophy (LH) is one such consequence. It is hypothesized that method of insulin delivery and poor delivery technique are significant risk factors for this condition which is believed to alter insulin pharmacodynamics. Subsequently, insulin pen needles are a critical component of care however access to pen needles varies across China.

Objective

The objective of this study is to characterize the insulin injecting population in China, determine the prevalence of LH and highlight attributable risk factors. This research is also intended to explore the relationship between pen needle reimbursement policy, injection practices, clinical outcomes and direct costs among insulin injecting diabetics in China.

Methods

A cross-sectional examination was conducted among 401 insulin users with Type 1 or Type 2 diabetes treated in outpatient endocrinology units of four large tertiary care hospitals in Nanjing, Chongqing, Beijing and Zhengzhou. Eligible participants were between the ages of 18-80 and taking insulin for a duration of greater than 1 year. Demographics, medical history including HbA1c, healthcare resource utilization (HRU), out-of-pocket costs, insurance and PN reimbursement status were surveyed. LH prevalence was clinically confirmed at the time of examination. Differences between those with and without LH were evaluated by Student’s t-test or Wilcoxon rank sum. Unit costs were assigned to insulin and healthcare HRU and compared using descriptive statistics and multivariate regression models.

Results

A total of 403 patients provided informed consent of which 401 completed the clinical module of the survey and 400 completed the HRU section. Half the study population was male (49.9%) with an average age of 59.6 year and BMI of 25.4 kg/m2. Most patients in this study were diagnosed with Type 2 diabetes (93%) and had diabetes for an average duration of 11.8 years and using insulin for 5.8 years (range 1-29.3 years). Prevalence of LH in this population was established to be 53.1%.

More than half the study population reported at least one diabetes related outpatient (OP) visit (62.7%) and 14.4% of the sample had at least one hospital stay in the past 6 months. The average number of diabetes related OP visits and hospital stays per patient was 2.55 (SD 2.55) and 0.177 (SD 0.516) respectively. The average daily insulin dose was 33.95 (SD 18.41) with patients reporting a range from 6 -118 units per day. Nearly 100% of study participants had some health insurance coverage (98%) and 35.5% had coverage for insulin pen needles.

LH prevalence was observed to be 18.6% higher in those without PN reimbursement (59.3% vs. 40.7%, p=0.0007). LH patients also exhibited higher HbA1c (8.2 vs 7.7%), insulin consumption (11U), median PN reuse (12 vs. 7 times per needle, p<0.0001), and costs (6-month insulin costs 1591 vs. 1328 RMB, p=0.0025; 6-month total HRU 6433 vs. 4432 RMB, p<0.0001). Injection site rotation and PN reuse frequency were both identified as risk factors for LH along with BMI and reimbursement. Incorrect injection site rotation had an odds ratio of 8.4 (p≤0.001).

Total cost of excess insulin consumption adjusted for adherence was estimated to be $313 million 2015 USD.

Conclusions

LH widespread complication among the insulin injecting diabetic population in China. LH is associated with higher insulin consumption and worse glycemic control. Insulin users without PN reimbursement may pose a greater economic burden to China compared to those with PN reimbursement. Injection site rotation and reduction in needle reuse may limit the development and impact of this complication. Furthermore, broader coverage for PN may reduce clinical and economic burden on the patient and healthcare system while improving quality of care.

Available for download on Sunday, August 08, 2021

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