High rate of non-adherence to insulin pump: over prescription, overuse or misuse? A population-based case-cohort study.

Transcription

1 High rate of non-adherence to insulin pump: over prescription, overuse or misuse? A population-based case-cohort study. Dr. Eugene Merzon MD; Ilia Merhasin, MBA; Dr. Avivit Golan-Cohen MD ; Dr. Shmuel Levit, MD, PhD; Prof. Shlomo Vinker, MD, MHA. Department of Managed Care, Medical Division, Leumit Health Services, Department of Family Medicine Tel Aviv University

2 Background

3 Background Dean Kamen, Inventor, Innovator & Entrepreneur

4 Background

5 Background Insulin pump Tubing Cannula Fixator Reservoir

6 Insulin Pumps on the Market Accu-Chek Combo System Asante Snap Insulin Pump System MiniMed Paradigm Real-Time Revel System (523/723) MiniMed 530G with Enlite (551/751) OmniPod Insulin Management System OneTouch Ping t:slim Insulin Pump V-Go Disposable Insulin Delivery Device Roche Health Solutions Asante Solutions Medtronic MiniMed Medtronic MiniMed Insulet Corporation Animas Tandem Diabetes Care Valeritas, Inc.

7 Background Clinical effectiveness of insulin pumps in Type 1 Diabetes A 2010 Cochrane review compared the use of CSII vs. MDI insulin regimens (23 randomized studies involving 976 patients with T1DM): A significant difference was documented in HbA 1c response, favoring IP. IP users demonstrated greater improvements in quality of life measures. Severe hypoglycemia appeared to be reduced in IP users. Misso ML, et al. Cochrane Database Syst Rev. 2010;(1):CD doi(1):cd CSII: continuous subcutaneous insulin infusion MDI: multiple daily injection T1DM: type 1 diabetes mellitus

8 Background Clinical effectiveness of of insulin pumps in Type 2 Diabetes Fewer clinical investigations have examined IP in patients with T2DM In an analysis of four randomized controlled trials involving patients with T2DM: No significant HbA 1c improvements, small differences in hypoglycemic risk, small weight differences were observed with IP vs. MDI over 12 to 52 weeks CSII: continuous subcutaneous insulin infusion T2DM: type 2 diabetes mellitus MDI: multiple daily injection Bode BW. Diabetes Technol Ther. 2010;12 Suppl 1:S17-21.

9 Background There are an increasing numbers of diabetic patients, who have been placed on insulin pump therapy in recent years in Israel. This device is expensive, the mean cost is 2000 GBP for the pump & 1000 GBP annual cost for supplies (NICE 2008). In Israel, patients, who meet the ministry of health criteria, receive the pump and related equipment free of charge. According to industry sponsored clinical trials adherence to insulin pumps is very high(90%), BUT there is uncertainty about patients' adherence to pumps in a real life.

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11 Background

12 Aim To evaluate adherence to insulin pump and the efficacy of treatment in a real life among type 1 and type 2 adult diabetics. To evaluate clinical, demographic and socioeconomic factors which are associated with failure to adhere to insulin pump therapy among type 1 and type 2 adult diabetics.

13 Methods We conducted a case-cohort study in Leumit Health Services. All patients above 20 years old, with type 1 or type 2 diabetes, who received insulin pump in years, were identified (N=707).

14 Methods Patients who didn't purchased pump maintenance supplies for more than 180 days, were defined as non-adhered or cases (N=355). Cases were compared to the other cohort members, who purchased the supplies and were defined as adhered (N=352).

15 Case-Cohort study design Multivariate regression analysis to calculate Odds ratios for association between patients characteristics and nonadherence to insulin pump treatment Cases Cohort

16 Results

17 Results

18 Results

19 Results

20 Results

21 Results

22 Hypnotic Tx. Results

23 Results P NS P< (9.0; 9.4) P<0.001 P<0.001 P=0.06 P<0.05 P<0.05

24 Results P NS P< (9.0; 9.4) P<0.001 P<0.001 P=0.06 P<0.05 P<0.05

25 Results OR (95%CI) P DM duration longer than 5 years ( ) P<0.001 Non-adherence to diet therapy 4.79 ( ) P<0.001 Uncontrolled DM before IP Tx (HgbA1c 9) 3.94 ( ) P<0.001 Type 2 DM 3.09 ( ) P<0.001 Muslim Arab Ethnicity 2.75 ( ) P<0.001 Age ( ( P<0.001 Smoking 1.65 (CI ) P<0.001 Hypnotic Tx (CI ) P<0.001 Obesity 1.41 ( ). P<0.05 High SES 0.65 ( ) P<0.001

26 Conclusions Only 50% of patients who received insulin pump remained adherent to treatment. Patients who were non- adherent, before starting insulin pump had the greatest odds to quit the pump therapy. Patient who were adherent to insulin pump had better diabetes control, lower rate of hospitalizations & ER visits. Although, patients, who were adherent to insulin pump, had significantly better glycemic control, the mean difference in Hgb A1C in the beginning and in the end of the study was the same in adherent & non-adherent patients.

27 Recommendations According to our data there is an overuse of insulin pump therapy, especially among type 2 DM diabetics. To prevent misuse, we recommend to exclude insulin pump therapy as a criteria for degrees of disability. Insulin pump does not improve adherence to treatment. Recommendation for placing on insulin pump should be based on patients individual characteristics, like history of adherence, health literacy and executive functioning, and not only on Hgb A1C level. IP should be used among highly motivated & educated patients.

28 Recommendations Innovation based on motivation and education. Dean Kamen, Insulin pump inventor, Innovator & Entrepreneur

29 THANK YOU FOR YOUR ATTENTION!