Original Article. Usage and Satisfaction of SoloStar Among Type2 Diabetic Patients in Pakistan

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1 Original Article Usage and Satisfaction of SoloStar Among Type2 Diabetic Patients in Pakistan Fouzia Moyeen 1, Nabeea Junaid 2. 1 Diabetes Wellness Centre, Lahore, Pakistan. 2 sanofi-aventis Pakistan limited. Volume: 3-Issue: 1 May 1, 2018 ESTABLISHED IN: 2015 ABSTRACT Background: SoloSTAR is a disposable insulin injection pen device. This study captured the satisfaction and usage of SoloSTAR pen by Type 2 Diabetes Mellitus (T2DM) patients in Pakistan. Methodology: This observational study conducted from December 2014 to September 2015 involved 30 sites from 5 cities in Pakistan. First ten adult T2DM patients ( 18 years) to whom physician decided to prescribe Lantus or Apidra SoloSTAR were enrolled. A questionnaire was administered at baseline and Visit 2 (3 ± 1 month). Satisfaction was measured at Visit 2 based on three parameters: Overall, Technical and Social satisfaction. Corresponding author: Nabeea Junaid. nabeea.junaid@sanofi.com Address: Plot No 23, Sector 22, Korangi Industrial Area, Karachi, Pakistan. Phone: Results: 295 patients were enrolled in this study. Their mean age was 52.1 (±9.8) years, duration of diabetes was 9.1 (±5.9) years. 54.2% were females. The most common impairment reported was visual (19.7%), hearing (2.7%) and impaired manual dexterity (2.7%). At follow-up, 241 patients returned at 3 (±1) months. 54.8% patients were insulin naive. SoloSTAR was assessed as satisfactory by 90% of patients whereas 99% patients rated the device as Excellent Good or Acceptable for technical and social parameters. All ten & twelve patients with hearing and manual dexterity impairment and of those visually impaired 92% (35/38) patients reported being very satisfied or satisfied with the device. The mean dose of Insulin Glargine and Insulin Glulisine was increased from 20.7 U to 24.7 U (<0.01) and 29.6U to 35.8 U (0.002) respectively. Three adverse events; hypoglycemia, lump formation and burning sensation at injection site were reported in three patients. No product technical complaint was received. Conclusion: This study showed that SoloSTAR pen was well accepted in urban T2DM patient population in Pakistan. It was perceived by patients to be easy to use and was associated with high levels of user satisfaction by T2DM patients. SAJMED.2018; 3(1): Copyright 2018 South Asian Journal of Medicine. Received at: February 22, 2018 Revised at: March 30, 2018 Published at: May 1, 2018 Conflict of Interest: The authors declared that there is no Conflict of Interest. Key Words: Insulin Pen, SoloSTAR, Type 2 Diabetes Mellitus, Overall Satisfaction 72

2 INTRODUCTION T ype 2 diabetes mellitus (T2DM) is a disease of considerable burden on patients and their caregivers, particularly for those in the more advanced stages who must rely on injectable therapies such as insulin and glucagon-like peptide-1 analogs to manage their disease. In light of the increasing prevalence of diabetes, along with the aging population and recommendations for earlier initiation of insulin therapy(1), injectable therapies will likely be increasingly relied on as beneficial therapeutics for the management of this disease. Pen device development has generated several high quality insulin pens, more and more tailored to the specific needs of patients, some even serve patient subgroups. This development has led to the situation where more and more patients are in favor of using insulin pens rather than traditional vials and syringes. From a clinical perspective, advantages of pens over syringes have been confirmed in numerous studies, including greater accuracy, ease of use, patient satisfaction, quality of life, and adherence (2,3). Lee WC et al (4) has demonstrated that converting from vial and syringe method to insulin pens is associated with improved medication adherence and a reduced likelihood of experiencing hypoglycemic events. Lantus SoloSTAR is a disposable insulin injection pen by Sanofi, which carries technical improvements compared to other available pens: Comparisons between SoloSTAR and two commonly used pens Flexpen and the Humulin /Humalog pen establish SoloSTAR as a state of the art pen that is suitable for most patients with diabetes (5). Injection force is an important practical aspect of therapy for patients with diabetes, especially those who have dexterity problems. Laboratory-based study showed, even compared with newer insulin pen devices, SoloSTAR stands out due to its low injection force as well as the possibility to inject up to 80 U of insulin in one injection with a comparatively short extension of the dial stroke (6). SoloSTAR pen is manufactured in two different exterior colors: grey for Lantus (insulin glargine) and blue for Apidra (insulin glulisine. This is the first time that a disposable insulin pen has differentiated the type of insulin contained in the pen using a different color pen body (5). Thus the SoloSTAR pen containing insulin glargine is called Lantus SoloSTAR, and the one containing insulin glulisine is called Apidra SoloSTAR. This difference in color pen body helpsto differentiate insulin pens by users with normal vision and by users with impaired color vision; this was demonstrated in a study conducted by Chasin.S & Morrissey.L7. It minimizes the risk of administering the wrong treatment furthermore, the Haak T et al study (8) has demonstrated the high patient preference for SoloSTAR. A survey on Lantus SoloSTAR, in everyday clinical practice, which was conducted in Australia from November 2006 to January 2007, showed that Lantus SoloSTAR had a good safety profile and was very well accepted by participants with a low incidence of participant reported problems during use (9). The European and Canadian (11) survey showed that SoloSTAR was well accepted in this large patient population. Most patients preferred SoloSTAR to their previous pen and 73

3 planned to continue SoloSTAR use. Being a SoloSTAR in Pakistan. This registry was disposable insulin delivery pen for the conducted to capture the satisfaction and usage of administration of Lantus (insulin glargine) and/or SoloSTAR pen by diabetic patients in real life in Apidra (insulin glulisine) there was no local data Pakistan. available on the usage and satisfaction of METHODS This study was conducted as an observational, national, multicenter, prospective, one time follow-up device registry. Internists or diabetologists practicing in Pakistan were selected as investigators through a randomization process. This random list contained 33 investigators accounting for an extra pool of 237 investigators as a backup in case some investigators declined participation. The first 33 investigators from the random selected list were contacted by the Local Study Team (LST) and were proposed to participate in the study. Each selected Investigator included ten consecutive patients who met inclusion criteria. This consecutive recruitment was to limit biases of subject selection. A screening log was implemented to document this consecutive enrolment. Investigators had three months to enroll ten patients as per recruitment criteria. First 10 adult patients 18 years of age, with type 2 diabetes mellitus, ability to self-administer SoloSTAR independently and willing to sign Data Release Consent form were selected. Patients participating in another investigational study, current temporary insulin treatment for gestational diabetes, pancreas cancer, surgery etc were excluded. Pregnant or breastfeeding women were also excluded from the study. Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy were also exempted from the study. The primary study outcome variable was Patient Satisfaction with the device determined based on responses of patients who returned for follow-up at visit 2 (3 ± 1 month). (B) Patient profile (C) Insulin dosage. Satisfaction was measured based on: (1) Overall satisfaction, (2) Technical satisfaction and (3) Social satisfaction. In Overall Satisfaction, each patient had the choice of selecting any one of the following five options: (1) very satisfied (2) satisfied (3) neutral (4) unsatisfied (5) very unsatisfied. Frequencies and percentages for each of the options were tabulated. Technical Satisfaction was measured based on 14 technical parameters of the SoloSTAR pen. The patient could rate each of these parameters as (A) Excellent, (B) Good, (C) Acceptable, (D) Poor and (E) Very Poor. Four parameters were used to measure Social satisfaction. The patient could express social satisfaction by using (A) Excellent, (B) Good, (C) Acceptable, (D) Poor and (E) very Poor. Each parameter was computed by summation of options and expressing this sum as a proportion (%) of patients returning for follow-up at any point in time irrespective of window period of 3 months. Variables used to capture patient profile on SoloSTAR included binomial and categorical variables for gender, insulin naïve, any hearing impairment not corrected by hearing aids, any manual dexterity impairment were presented as frequency and percentages. Age (years), weight (kg), height (cm), years of education, duration of diabetes (years) and HbA1c (%) were treated as 74

4 continuous variables and reported as means (Standard Deviation). Individual dose of insulin administered at the end of three months in newly insulinized patients was considered as continuous variable and presented as means and standard deviation. RESULTS Patient Recruitment: Data collection for 330 patients was planned years, (median 8 years, range 1 to 30 years). The mean (±S.D) HbA1c of these patients was involving 33 Investigators/sites. Thirty 9.3 % (±1.7). There were 57.6% insulin naïve Investigators/sites could recruit 295 patients during the specified study timelines (Three months). Of the 295 patients 241 returned for a follow-up visit at 3 ± 1 month (Fig 1). The reasons cited by the investigator for the 54 patients who did not return for follow-up included (a) lost to follow-up (N=52) and refusal to continue in the study (N=1). The patients. The HbA1c of insulin naive patients was 9.2% (±1.8) and for insulinized patients was 9.3% (±1.7), p=0.88. The mean (±SD) weight was 74.6 (±15.4) kg. Mean (±SD) computed BMI was 28.3 (±5.6) kg/m2 with 16% patients having a BMI less than 22.9 kg/m2. There were 31% patients who were overweight with BMI of kg/m2 and study was conducted between 18th 53% patients were obese 27.5 kg/m2. December 2014 and 12th September Of the three impairments inquired, the most The enrolled study population (Table 1) included 54% females. The mean (±S.D) age common reported were visual (19.7%), hearing (2.7%) and impaired manual dexterity (2.7%). was 52.1 (±9.8) years. The mean duration of schooling was 10.7 (±4.2) years. The mean (±S.D) duration of diabetes was 9.1 (±5.9) Table 1: Demographic characteristics of enrolled T2DM patients 75

5 Of the 295 patients who were enrolled in the study, 241 (81.7%) returned for the mandatory follow up visit at 3 (±1) months. The follow-up study population included 51% females. The mean (± S.D) age was 51.7 (±9.9) years. The mean duration of schooling was 11 (±3.9) years. The mean(±s.d) duration of diabetes of the 241 patients who returned for follow-up was 9.2 (±5.9) years,(median 8 years, and range 1 to 30 years). The mean (± S.D) HbA1c level of these patients was9.3 (±1.8) (%). There were 54.8% insulin naïve patients. The mean (± S.D) weight was 74.7 (±14.4) kg. Mean (± S.D) computed BMI was 28.3 (±5.1) kg/m 2 with 15% patients having a BMI less than 22.9 kg/m 2. There were 32% patients who were overweight with the BMI of kg/m 2 and 54% patients were obese 27.5 kg/m 2. Seventy two percent (211/295) patients returned within window period (3 ± 1 month) and 10% (30/295) patients returned after four months. Of the three impairments inquired the most common reported was visual (15.8%), hearing (2.1%) and impaired manual dexterity (2.5%). A comparison of baseline characteristics indicates that patients who returned at follow up did not significantly vary from those who did not return at follow up except for the following: gender, duration of education, insulin naivety and visual impairment. More males (n=119/135) returned for their follow up compared to females (n=122/160). Comparison between gender indicates that females were less likely to return for a follow up compared to males (70.4% vs 29.6%, p=0.008). Patients who returned for follow up had two additional years of education compared to those who did not return (11.0±3.9 vs 9.0±5.0, p=0.003). A significantly larger proportion of patients who did not return for a follow up visit were insulin naïve (70.4%) compared to those who returned for a follow up (54.8%), (p=0.04). Similarly, patients with visual impairment (37% not returned vs. 15.8% returned; p=0.001) were less likely to return for follow up visit. Mean HbA1c levels for both group of patients were not significantly different (8.9±1.4% vs 9.3±1.8%). However, a greater proportion of patients with HbA1c ranging from 7.1 to 8% were less likely to come for a follow up visit compared to those to who returned (24% vs 15%). Table2. Table 2: Comparison of baseline characteristics of patients who either returned or did not return at follow up visit at 3 months. 76

6 *statistically significant (p<0.05) Overall Satisfaction of SoloSTAR : window period there is no significant difference In the overall assessment of SoloSTAR by 241 patients who returned for follow up (irrespective of window period), 90% rated the device as satisfactory {summation of very satisfied (54.4%) and satisfied (35.3%)}. Table 3. Comparing overall satisfaction of patients returning within window period and outside (91.5% vs 93.4%). However, a greater proportion of patients outside the window period reported being very satisfied with a use of SoloSTAR device compared to those returning within window period (76.7% vs 53.6%). Table 3: Overall satisfaction of SoloSTAR device as reported by patients returning for follow-up 77

7 All ten patients with hearing impairment (Table 4) and twelve patient with manual dexterity SoloSTAR pen, on an overall basis, 99% (238/241) patients reported being satisfied impairment (Table 4) reported being satisfied (summation of Excellent, Good, and with the SoloSTAR device. Among visually Acceptable). All patients were satisfied with the impaired 92% patients reported being satisfied ease of selecting and correcting the with the SoloSTAR device (Table 4). 2. Technical Parameters: When patients were asked to provide objective insulin dose as features of the SoloSTAR pen. Most patients (>98%) found all other features/technical parameters to be satisfactory (Table 5). feedback on technical parameters on Table 4. Overall Satisfaction on SoloSTAR device as reported by patients with Impairments. Table 5. Satisfaction of SoloSTAR device based on technical parameters as reported by patients returning for follow up 78

8 Technical parameter by visual impaired: Overall assessment of technical features of the SoloSTAR pen by the 38 visually impaired individuals was reported as satisfactory by all of them. The following proportion of patients reported satisfaction on parameters that directly are related to visual functions: selecting desired dose (100%), reading insulin dose (100%), correcting misdialed dose (97.4%), and reading remaining dose of insulin in cartridge (97.4%). All five patients with hearing impairment reported being satisfied with the technical parameters of the pen including, hearing of dialing clicks. 3. Social parameters: The overall satisfaction of SoloSTAR pen measured on social parameters in 241 patients returning for follow up is almost universal ranging from 99 to 100%. The four parameters assessed included: (i) being discrete (100%), (ii) being less embarrassing when used in public (99%), (iii) increasing confidence in managing diabetes (99%) and (iv) reducing reluctance to take injection (99%). Within window period: During the study, the majority of the patients (91.5 %, n=193) were satisfied on SoloSTAR device for using injecting insulin. SoloSTAR pen was perceived positive as shown by majority of the patients who rated SoloSTAR as satisfactory across all 13 factors. In particular, the ease of selecting the dose (100%, n=211) and the ease of correcting a misdialed dose (100%, n=211) were rated very highly for SoloSTAR. Less than (11%, n=22) rated SoloSTAR as poor or very poor for 13 factors. Of 295 recruited patients eligible to receive insulin 291 (98.6%) were prescribed Lantus and 23 (7.8%) were prescribed Apidra. (Table 5). Almost half of the patients (49.5%) were prescribed Lantus as a sole therapy. Another 40% were prescribed Lantus along with OADs, and 6.4% patients were prescribed a combination of Lantus and Apidra. In the 241 patients the mean overall doses of Lantus and Apidra were up titrated. The mean dose of Lantus was increased from 20.7 U to 24.7 U (p<0.01). Similarly, the mean dose of Apidra was increased from 30.1 U to 35.8 U (p=0.002). Two thirds of the patients were able to handle the device to titrate their doses. At FU visit, 18.7 % (45/241) patients reported with FPG 100 mg/dl. Patients on combination of Lantus and Apidra did not require a significant up titration while those either on Lantus alone or in combination with OAD required an up titration. Table 7. Table 6: Overall satisfaction on social parameters rating on SoloSTAR assessed on 3 months follow up. 79

9 Table 7: Treatment regimen during the registry study. Regimen Baseline visit (N=241) N(%) Mean (SD) insulin glargine units Mean (SD) insulin glulisine units Mean (SD) insulin glargine units (a) Insulin glargine (±13.3) - SoloSTAR (44.8) (±13.6) (b) Insulin glargine (±8.6) - SoloSTAR+OAD (41.5) (±10.2) (c) Insulin glargine and insulin glulisine 10 (4.1) (±11.8) (±16.1) (±13.4) SoloSTAR +OAD (d) Insulin glargine SoloSTAR+ insulin 19 (7.9) (±14.3) (±13.7) (±10.1) glulisine SoloSTAR (e) Insulin glulisine SoloSTAR+OAD 4 (1.7) (±1.4) - Overall Insulin dose Insulin glargine per day (a+b+c+d) (98.3) (±12.1) Insulin glulisine per 33 day (c+d+e) (13.7) *statistically significant (p<0.05) Follow up visit (n=241) Mean (SD) Insulin insulin glargine glulisi p-value ne units insulin glulisin e p- value < (±14.5) 41.1 (±13.1) 19.0 (±15.6) (±16.3) - - During the study period three adverse events in three patients from three sites were reported. These events were hypoglycemia, lump formation at injection site and burning sensation at injection site. There were no products technical complaints received neither from any of the 30 investigator sites nor from the 295 enrolled patients. Discussion 80

10 Disease progression in diabetes eventually leads to the requirement for exogenously administered insulin to achieve glycaemic control (10). However, due to various factors that contribute to the patients psychological resistance fear of needles and concerns about weight gain and hypoglycemia insulin use can be hampered or delayed, resulting in unchecked progression of diabetic complications (11,12). It is therefore critical to evaluate satisfaction of treatment regimens from the patient s perspective to ensure a positive impact on compliance and adherence. The present registry study captured the satisfaction and usage of SoloSTAR pen by Type 2 Diabetes Mellitus (T2DM) patients in Urban Pakistan. This study shows that SoloSTAR was well accepted in this urban patient population in Pakistan. Overall, the results obtained in this study are consistent with those reported in similar observational surveys of Australian patients(13) and that from Pan-European and Canadian Prospective Survey. Infact, almost 85-90% of the patients in the study rated SoloSTAR as excellent or good for ease of use and learning, despite almost 55% of patients in this study being naïve to prior insulin therapy, which again is comparable to the other studies. Furthermore, 15.8% of participants of the observational study who had visual impairments, also reported a similar level of satisfaction using SoloSTAR (mostly satisfied or very satisfied )(14). Shirmeen Ijaz and M. Asir Ajmal (15) has reported that diabetes treatment in Pakistan has a great impact on patients and caregivers family and social life, psychological and physical health. The social satisfaction parameters in the current study show that SoloSTAR was perceived to increases confidence in ability to manage diabetes using insulin, reduce embarrassment and increase chance of compliance to treatment among 90% of patients. In this study, insulin delivery with SoloSTAR was well tolerated, with only 3 TEAEs reported. Most adverse events were considered to be associated with the use of insulin glargine or insulin glulisine, rather than the use of the SoloSTAR device to inject the insulin. This observation, in combination with the accuracy of SoloSTAR previously demonstrated in real life clinical settings, should provide reassurance to patients and physicians alike that SoloSTAR could be appropriate for many patients, with low risk of patient errors in use. The findings of this study must be weighed against a number of limitations. First, this study was performed in a nonrandomized patient population with a limited sample size of 295 patients from the urban settings. However, the perceptions of the previous device should not be directly compared with that of SoloSTAR, because these patients did not provide feedback on their previously used pen. Also, this study did not specifically evaluate the use of SoloSTAR in sizeable number of people with either severe visual or dexterity impairments. As these impairments are common among people with diabetes, future studies should assess the use of SoloSTAR in people with severe visual or dexterity impairments. Preliminary evidence suggests that visually impaired people are just as capable as those without impairment at selfadministering insulin using pen devices(16). Conclusion This study showed that SoloSTAR pen was well accepted in urban T2DM patient population in Pakistan. In the light of previous studies reported elsewhere (14,17), the results of this study that SoloSTAR is perceived by patients to be easy to use and is associated with high levels of user satisfaction. Future randomized controlled trials to compare the clinical utility of SoloSTAR versus the vial and syringe would be valuable, both in terms of assessing overall effects on patient satisfaction and glycemic control and in terms of risk of hypoglycemia and overall treatment costs. Acknowledgement The authors acknowledge Mr. Iqbal Mujtaba (sanofi-aventis Pakistan limited) for providing statistical support..references 81

11 1. Standards of medical care in diabetes American Diabetes Association. Diabetes Care. 2011; 34 (1): Bastian MD, Wolters NE, Bright DR. Insulin pens vs. vials and syringes: differences in clinical and economic outcomes. Consult Pharm. 2011;26(6): Dang DK, Lee J. Analysis of symposium articles on insulin pen devices and alternative insulin delivery methods. J Diabetes Sci Technol. 2010;4(3): Lee WC et al. Medication adherence and the associated health-economic impact among patients with type 2 diabetes mellitus converting to insulin pen therapy: an analysis of thirdparty managed care claims data. Clin Ther 2006;28(10): Clarke A, Spollett G. Dose accuracy and injection force dynamics of a novel disposable insulin pen. Expert Opin Drug Deliv 2007;4(2): Thomas van der Burg. Injection Force of SoloSTAR Compared with Other Disposable Insulin Pen Devices at Constant Volume Flow Rates. J Diabetes Sci Technol. 2011; 5(1): Chasin.S, Morrissey.L. Pen colors facilitate the differentiation of SoloSTAR insulin pens by users with normal and impaired color vision. Diabetes Management, Vol. 3, No.1,Pages Haak T et al. Comparison of usability and patient preference for the new disposable insulin device SoloSTAR versus Flexpen, Lilly pen, and a prototype pen: an open-label study. Clin Ther 2007;29: Carter L et al. Usability, participant acceptance and safety of SoloSTAR in an observational survey in everyday clinical practice. J Diabetes Sci Technol : Turner, R.C., Cull, C.A., Frighi, V. and Holman, R.R. Glycemic Control with Diet, Sulfonylurea, Metformin, or Insulin in Patients with Type 2 Diabetes Mellitus, Progressive Requirement for Multiple Therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. Journal of the American Medical Association, 1999, 281: Peyrot, M., Rubin, R.R., Lauritzen, T., et al. Resistance to Insulin Therapy among Patients and Providers, Results of the Cross-National Diabetes attitudes, Wishes, and Needs (DAWN) Study. Diabetes Care, 2005, 28: Hayes, R.P., Fitzgerald, J.T. and Jacober, S.J. Primary Care Physician Beliefs about Insulin Initiation in Patients with Type 2 Diabetes. International Journal of Clinical Practice, 2008 ; 62: Carter J, Roberts A. Usability of a prefilled insulin injection device in a 3- month observational survey of everyday clinical practice in Australia. Curr Med Res Opin. 2008;24(10): Carter J, Beilin J, Morton A, De Luise M. Usability, participant acceptance, and safety of a prefilled insulin injection device in a 3-month observational survey in everyday clinical practice in Australia. J Diabetes Sci Technol. 2009;3(6): Ijaz and Ajmal Experiencing Type II Diabetes in Pakistan, Pakistan Journal of Social and Clinical Psychology 2011; 9: Williams AS, Schnarrenberger PA. A comparison of dosing accuracy: visually impaired and sighted people using insulin pens. J Diabetes Sci Technol. 2010;4(3): Haak T, Edelman S, Walter C, Lecointre B, Spollett G. Comparison of usability and patient preference for the new disposable insulin device Solostar versus Flexpen, lilly disposable pen, and a prototype pen: an open-label study. Clin Ther. 2007;29(4):