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Pharmacy and Therapeutics

Insulin Pump Class: Back to the Basics of Pump Therapy Sara Wilson Reece, PharmD, CDE, BC-ADM, CPhT, and Cheryl Lynn Hamby Williams, RN, CDE

In the early 1960s, Dr. Arnold therapy to traditional MDI regimens Kadish developed the first insu- with regard to long-term glycemic lin pump, which was the size of a control and minimization of hypo- Marine backpack.1 Over the years, glycemia.6–11 Then, in 1993, the pumps have become much Control and Complications more refined and have decreased Trial12 confirmed the importance in bulk to the size and weight of a of intensive glycemic control using small pager. Insulin pump therapy, either insulin pump therapy or an also known as continuous subcuta- MDI regimen along with frequent neous insulin infusion, is no longer self-monitoring of blood glu- seen as experimental and contro- cose (SMBG). versial, but rather is viewed as an In patients with , acceptable alternative to multiple pump therapy has been shown to daily injection (MDI) therapy in the limit excess weight gain, reduce management of insulin-dependent the frequency of severe hypoglyce- diabetes2 (Table 1). 3 mia, and lower A1C levels.13 Pump The insulin pump is an electro- therapy is also a therapeutic alterna- mechanical device that mimics the tive for insulin-requiring patients body’s natural insulin secretion from with , especially those pancreatic β-cells by subcutaneously who require large amounts of insu- delivering rapid-acting insulin both lin, have severe , at preset continuous basal rates and and have poor glycemic control,14,15 in extra bolus doses at mealtimes and has been observed to reduce on demand.4 Insulin pumps allow insulin requirements and lower A1C for up to 24 different hourly basal levels in patients with type 2 diabe- rates in a 24-hour period. For bolus tes.14,16 Compared to MDI, insulin doses, pump users input their current pump therapy allows for greater blood glucose level and the number flexibility with timing of meals, of carbohydrates they will consume, reduces the risk of exercise-induced and the pump customizes their dose , allows for overnight based on insulin currently on board glycemic control, and gives patients (i.e., the remaining active insulin greater ability to manage their from the previous dose), their indi- own diabetes.13 vidualized insulin-to-carbohydrate Insulin pumps consist of a ratio, and their individualized insulin reservoir, a pump, and an infusion sensitivity factor (i.e., their expected set. The reservoir, which is similar drop in blood glucose from 1 unit to a syringe, holds a 2- to 3-day of insulin).1,5 Thus, insulin pumps supply of insulin and is placed into are able to deliver insulin in a more the battery-powered pump. The physiological manner than other infusion set consists of tubing that injection-based insulin regimens.5 connects the reservoir to a cannula In the late 1970s, results of the (i.e., a tiny tube to deliver insulin first human trials of insulin pump subcutaneously) and transports therapy were published. This was the insulin from pump to patient. followed by numerous additional A small piece of adhesive holds the studies comparing insulin pump cannula in place at the insertion site.1 Diabetes Spectrum Volume 27, Number 2, 2014 135 Pharmacy and Therapeutics Additional Product Details Meter remote and pump can each control nearly all pump functions from 6 ft.Works away 8 ft. to Watertight up deep 1 hour for Protective available “skins” with Accu-ChekWorks 360° software, insulin pump configuration software, and Smart Pix device data reader for management withCompatible Windows Windows 7), (except with not but MacIntosh operating systems usesMenu icons instead words of Does with work not data management software glucoseBuilt-in continuous monitoring technology Pump disconnects bathing for swimming or Protective available “skins” with CareLinkWorks Personal software Compatible with Windows (including Windows 7 and Vista) and MacIntosh operating systems No tubing required functions control andpod’s to Pod PDM 25 to ft. up for deep 1 hourWaterproof for Protective available “skins” with Abbott’s CoPilotWorks data management software withCompatible Windows Windows 7), (except with not but MacIntosh operating systems Meter remote and pump can each control nearly all pump functions ft. 10 Meter to away up remote works Pump 12 ft. to up is for waterproof deep for 24 hours Protective available “skins” with ezManagerWorks Max data management software withCompatible Windows Windows 7) (except and MacIntosh operating systems screenColor touch and rechargeable battery Pump 3 ft. to up is for waterproof deep for 30 minutes with T:ConnectWorks Therapy Management Compatible withCompatible Windows and MacIntosh systems operating pump specificallyPatch designed use for in adults with type 2 diabetes; recommended not people withfor type 1 diabetes Delivers insulin with button presses instead electronicsof Each patch is used hours 24 for and then disposed and of replaced Pump 3 feet, to up is for waterproof 3 inches deep hours 24 for No data management software 3 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Information Meter Interaction Yes; Accu-ChekYes; Aviva Combo meter remote sends results wirelessly to pump No Contour NextYes; Link meter wirelessly sends results to pump blood FreeStyle Yes; is built into the Personal Diabetes Manager to (device wirelessly program insulin delivery) meter remote Yes; sends results wirelessly to pump No No Table 1. Comparison 1. Table of Current Insulin Pumps Infusion Set Information Compatible with all all with Compatible standard Luer-lock connectors specific (a type connector of with a locking mechanism) Compatible with Sooil infusion sets only Compatible with Medtronic infusion sets. Does use not tubing; Pod comes with a built-in infusion set, cannula, inserterand automated all with Compatible standard Luer-lock connectors all with Compatible standard Luer-lock connectors Does use not tubing; pump comes with a built- in infusion set, cannula, inserterand automated Reservoir Information 315-unit cartridge 315-unit cartridge 300-unit Model 176-unit 523: reservoir or Model 723: 176- 300-unit reservoir (wirelessPod insulin includes pump) built-in reservoir that holds 200 units cartridge 200-unit cartridge 300-unit V-Go 20: 20 units V-Go 30: 30 units V-Go 40: 40 units

Company/Pump Roche Insulin Delivery Systems/ Accu- Chek Combo Sooil Development/ Dana Diabecare IIS Medtronic Diabetes/ Revel Insulet/OmniPod Animas/ Ping OneTouch Diabetes Tandem Care/T:slim Valeritas/V-Go

136 Diabetes Spectrum Volume 27, Number 2, 2014 Pharmacy and Therapeutics Pharmacy and Therapeutics

The needle of the infusion set can nurse (team leader), a registered be inserted into the abdomen, upper dietitian, and a pharmacist, all of thigh, or upper arm. The infusion set whom are certified insulin pump and reservoir must be changed every trainers. The department offers vari- 2–3 days. ous services, including individual and The indications for insulin pump group diabetes education, gestational therapy include inadequate glycemic diabetes education and management, control (defined as an A1C > 7%, the pediatric obesity education classes, dawn phenomenon [early-morning and insulin pump therapy education increase in blood glucose], and and management. marked variability in glucose from Approximately 20% of all IM day to day); hypoglycemic episodes and FM patients have diabetes. requiring assistance or hypoglycemia Forty-seven percent of these diabetes unawareness; the need for flex- patients are on insulin therapy, of ibility in lifestyle; and pregnancy or which 3% use an insulin pump. For Additional Product Details intention to become pregnant.13,17 All patients on insulin pump therapy, candidates should have the willing- 99% use the MiniMed Paradigm ness and ability to learn how to use Revel insulin pump and 1% use other Meter remote and pump can each control nearly all pump functions from 6 ft.Works away 8 ft. to Watertight up deep 1 hour for Protective available “skins” with Accu-ChekWorks 360° software, insulin pump configuration software, and Smart Pix device data reader for management withCompatible Windows Windows 7), (except with not but MacIntosh operating systems usesMenu icons instead words of Does with work not data management software glucoseBuilt-in continuous monitoring technology Pump disconnects bathing for swimming or Protective available “skins” with CareLinkWorks Personal software Compatible with Windows (including Windows 7 and Vista) and MacIntosh operating systems No tubing required functions control andpod’s to Pod PDM 25 to ft. up for deep 1 hourWaterproof for Protective available “skins” with Abbott’s CoPilotWorks data management software withCompatible Windows Windows 7), (except with not but MacIntosh operating systems Meter remote and pump can each control nearly all pump functions ft. 10 Meter to away up remote works Pump 12 ft. to up is for waterproof deep for 24 hours Protective available “skins” with ezManagerWorks Max data management software withCompatible Windows Windows 7) (except and MacIntosh operating systems screenColor touch and rechargeable battery Pump 3 ft. to up is for waterproof deep for 30 minutes with T:ConnectWorks Therapy Management withCompatible Windows and MacIntosh operating systems operating pump specificallyPatch designed use for in adults with type 2 diabetes; recommended not people withfor type 1 diabetes Delivers insulin with button presses instead electronicsof Each patch is used hours 24 for and then disposed and of replaced Pump 3 feet, to up is for waterproof 3 inches deep hours 24 for No data management software an insulin pump and to perform brands of insulin pumps. All insulin 1,4 3 SMBG multiple times per day. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • pump patients are referred to the Patients with significant psychologi- diabetes education department for cal problems such as psychosis or pre-pump, pump start, and follow- severe depression are not appro- up training sessions. After the initial 4 priate candidates. training sessions, many of the insulin Ongoing education, motiva- pump patients continue to be seen tion, and psychological support are by the diabetes education staff for required for patients to succeed with review of insulin pump downloads insulin pump therapy. Patient educa-

Information and adjustment of pump settings. tion should include the principles of

Meter Interaction The lead CDE conceived the insu- basal-bolus insulin therapy, sick-day lin pump class after several patients Yes; Accu-ChekYes; Aviva Combo meter remote sends results wirelessly to pump No Contour NextYes; Link meter wirelessly sends results to pump blood FreeStyle Yes; glucose meter is built into the Personal Diabetes Manager to (device wirelessly program insulin delivery) meter remote Yes; sends results wirelessly to pump No No management, carbohydrate count- on pump therapy had severe hypo- ing, administration, site glycemic episodes while driving. She preparation and infection prevention, identified the need for insulin pump prevention and treatment of hypo- patients to have follow-up training to and , and insulin review insulin pump survival skills adjustments for exercise.17 The most and prevent future hypoglycemic crucial factors for patient success are emergencies. A database search of patients’ willingness to perform fre- IM and FM patients was completed quent SMBG and sufficient ongoing to identify the subset of patients on clinical support.17 insulin pump therapy. Table 1. Comparison 1. Table of Current Insulin Pumps Infusion Set Information Compatible with all all with Compatible standard Luer-lock connectors specific (a type connector of with a locking mechanism) Compatible with Sooil infusion sets only Compatible with Medtronic infusion sets. Does use not tubing; Pod comes with a built-in infusion set, cannula, inserterand automated all with Compatible standard Luer-lock connectors all with Compatible standard Luer-lock connectors Does use not tubing; pump comes with a built- in infusion set, cannula, inserterand automated Program Background Via phone or during office visits, The Longstreet Clinic (TLC) is a CDEs invited established insulin regional multidisciplinary physician pump patients identified through practice. The Internal Medicine (IM) the database search to attend the and Family Medicine (FM) depart- class. All insulin pump patients were ments are located in Gainesville invited to the subsequent insulin and Oakwood (Hall County), Ga. pump classes. Baseline characteristics Reservoir

Information Hall County is located in north- of the patients who attended the class east Georgia 50 miles northeast of are described in Table 2. 315-unit cartridge 315-unit cartridge 300-unit Model 176-unit 523: reservoir or Model 723: 176- 300-unit reservoir (wirelessPod insulin includes pump) built-in reservoir that holds 200 units cartridge 200-unit cartridge 300-unit V-Go 20: 20 units V-Go 30: 30 units V-Go 40: 40 units Atlanta. The population of Hall To assist with class attendance, County is ~ 187,700. patients received a reminder call 1 Within the IM and FM depart- day before class. ments, the Diabetes Education and Although initial education for Medical Nutritional Therapy depart- insulin pump therapy focuses on the ment provides diabetes education basics of pump operation, the class and management services for patients provides more in-depth education with diabetes. Within this depart- about sick-day management, infusion ment, there is an interdisciplinary site problems, and additional keys to Company/Pump team of certified diabetes educators pump success. The objectives of the Roche Insulin Delivery Systems/ Accu- Chek Combo Sooil Development/ Dana Diabecare IIS Medtronic Diabetes/ MiniMed Paradigm Revel Insulet/OmniPod Animas/ Ping OneTouch Diabetes Tandem Care/T:slim Valeritas/V-Go (CDEs) composed of a registered class are to review insulin pump sur- Diabetes Spectrum Volume 27, Number 2, 2014 137 Pharmacy and Therapeutics

Table 2. Baseline • Infusion site care: infusion to six participants (Table 3). The set types and sites and outcomes data collected for the class Demographics of Class infection prevention included pre- and post-class A1C Participants values, pre- and post-class emergency Although these topics are dis- room visits, and post-class satisfac- Characteristic Frequency cussed during the initial insulin tion (Tables 4–6). Type of Diabetes pump training, material is covered in more depth in class, and participants A1C results Type 1 18/35 can share their experiences. In addi- The average pre- and post-class A1C Type 2 17/35 tion to these discussions, patients levels were calculated based on the are also given survival skills kits pre- and post-class A1C levels for Sex that contain written handouts about each participant. As demonstrated in Female 22/35 these topics to enforce learning. The Table 4, the overall average pre-class kits also contain glucose tablets, a A1C has been 7.4%, with an overall Male 13/35 diabetes driver decal, and a bag of average standard deviation of 0.44. Race U-100 insulin syringes. After the The overall average post-class A1C roundtable discussion, adjustments has been 7.2%, with an overall aver- African 3/35 age standard deviation of 0.2. American to insulin pump settings are made as needed with CDEs and each patient Emergency room visits White 32/35 individually. Patients are given a copy The initial assessment of emergency of their insulin pump settings. Age (years) room visits was the number of visits As the class comes to an end, in the 12 months before the class 30–35 2/35 patients complete a post-class date. For the 35 patients enrolled in satisfaction survey and are given a 40–49 6/35 the class, there had been a total of follow-up appointment. 50–59 10/35 four emergency visits, two of which Outcomes were diabetes-related. Tracking of 60–69 12/35 As the class was developed, the initial post-class emergency room visits 70–79 5/35 goal was to enroll six insulin pump is ongoing. To date, there has been patients every 6–8 weeks, with the only one emergency room visit by a class participant, and that visit was vival skills for new and experienced first session to be held in July 2011. diabetes-related. pump patients to prevent emergency From July 2011 to May 2013, 10 ses- room visits, improve glycemic sions have been held, with a total of Satisfaction survey control (as measured by A1C), and 30 participants completing the class. Participants who completed the sur- provide patient satisfaction. Although the initial goal was to have vey in the class found the roundtable six insulin pump patients per class, discussions, handouts, and visual Insulin Pump Class Structure actual class size has varied from two Each class takes 90 minutes. All aids to be helpful. The majority of participants who completed the sur- patients who have attended the class Table 3. Insulin Pump Class use the MiniMed Paradigm Revel vey (92.9%) learned at least one new Attendance skill for their insulin pump therapy. insulin pump system, so the educa- All respondents felt that what they tional materials discussed during Class Actual learned will help them manage their the session focus on this product. Date Attendance/ insulin pump therapy and that their When patients arrive for class, a Goal questions were answered. All survey CDE downloads their insulin pump. Attendance respondents agreed to put their While insulin pumps are being July 2011 6/6 survival kit together and said they downloaded, another CDE begins August 2011 6/6 would recommend the class to others the interactive educational round- (Tables 5 and 6). table, which focuses on insulin pump September 2011 3/6 survival skills. Topics for the round- Challenges and Ongoing table include: October 2011 4/6 Development • Advanced carbohydrate counting December 2011 3/6 Although these results indicate that using food models the class has been successful, there • Battery changing and adjustment March 2012 3/6 are several limitations. The sample of pump settings April 2012 2/6 size for the class is relatively small. • prevention Additionally, the timeframe for • Troubleshooting unexplained September 2012 4/6 measuring the impact of the class on high blood glucose levels April 2013 2/6 A1C level and number of emergency • Prevention and treatment room visits has been short. Overall, of hypoglycemia May 2013 3/6 participants in this class were already 138 Diabetes Spectrum Volume 27, Number 2, 2014 Pharmacy and Therapeutics

Table 4. Differences in Participants’ Pre- and Post-Class A1C Levels Class Date Pre-Class Pre-Class Post-Class Post-Class A1C Standard A1C Standard (mean %) Deviation (mean %) Deviation July 2011 7.1 0.43 7.4 0.42 August 2011 7.5 0.55 7.5 0.40 September 2011 7.0 0.85 6.9 0.94 October 2011 7.4 0.51 7.0 0.35 December 2011 8.0 0.10 7.4 0.65 March 2012 7.2 0.51 7.4 0.92 April 2012 7.4 0.05 6.4 0.00 September 2012 7.4 0.90 6.8 0.25 April 2013 6.6 0.20 6.4 0.20 May 2013 8.3 0.28 8.5 1.77 Overall 7.4 0.44 7.2 0.2 Table 5. Class Participant Post-Class Survey, Part A (n = 28)* Item Likert Scale Results Strongly Disagree Neutral Agree Strongly Disagree Agree Roundtable discussion was helpful 0 0 0 4 24 Handouts and visuals were helpful 0 0 0 5 23 I learned at least one new skill for my insulin 0 1 1 3 22 pump therapy What I learned will help me manage my 0 0 0 5 23 insulin pump therapy My questions were answered 0 0 0 3 25 *Although 35 participants completed the class, 28 participants completed the survey.

Table 6. Class Participant Post-Class Survey, Part B (n = 28)* 2American Diabetes Association: Standards of medical care for patients with diabe- Item Yes No tes mellitus—2013. Diabetes Care 36 (Suppl.1):11–66, 2013 I will put my survival kit together 28 0 3Neithercott T: Insulin pumps. Diabetes I will recommend this class to others 28 0 Forecast 65:50–53, 2012 4Keen H, Pickup J: Continuous subcutaneous *Although 35 participants completed the class, 28 participants completed insulin infusion at 25 years. Diabetes Care the survey. 25:593–598, 2002 5Rubin RR, Peyrot M: Patient-reported compliant to their insulin pump The CDE team is also consider- outcomes and diabetes technology: a systemic therapy regimen. ing the addition of insulin pump review of literature. Pediatric Endocrinol Rev CDEs are working to identify “happy hours” on Friday afternoons 7 (Suppl. 3):405–412, 2010 additional pump patients to enroll as a drop-in option for patients 6Jackisch BI, Wagner VM, Heidtmann B, in the class, with the ultimate goal who are unable to attend the Lepler R, Holterhus PM, Kapellen TM, Vogel of having all insulin pump patients scheduled class. C, Rosenbauer J, Holl RW: Comparison of in the medical practice complete the continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) course to improve glycemic control References in pediatric type 1 diabetes: a multicentre (as indicated by the A1C), reduce matched-pair cohort analysis over 3 years. 1Fernandez MP, Marcus AO: Insulin pump Diabet Med 25:80–85, 2008 the number of diabetes-related therapy: acceptable alternative to injec- emergency room visits, and ensure tion therapy. Postgrad Med 99:125–132, 7Hoogma RP, Hammond PJ, Gomis R, Kerr patient satisfaction with the class. 141–144, 1996 D, Bruttomesso D, Bouter KP, Wiefels KJ, de Diabetes Spectrum Volume 27, Number 2, 2014 139 Pharmacy and Therapeutics

la Calle H, Scchweitzer DH, Pfohl M, Torlone parallel-group, 24-week study. Diabetes Care 16Wainstein J, Metzger M, Wexler, Cohen J, E, Krinelke LG, Bolli GB: Comparison of the 26:2598–2603, 2003 Raz I: The use of continuous insulin delivery effects of continuous subcutaneous insulin 11 systems in severely insulin-resistant patients. infusion (CSII) and NPH-based multiple daily Tamborlane WV, Sherwin RS, Genel M, Diabetes Care 21:1910–1914, 1998 injections (MDI) on glycemic control and Feliq P: Reduction to normal of plasma glucose in juvenile diabetes by subcutaneous quality of life: results of the 5-nations trial. 17Scheiner G, Sobel RJ, Smith DE, Pick AJ, Diabet Med 23:141–147, 2006 administration of insulin with a portable infu- sion pump. N Engl J Med 300:573–578, 1979 Kruger D, King J, Green K: Insulin pump 8Doyle EA, Weinzimer SA, Steffen AT, Ahern therapy: guidelines for successful outcomes. 12DCCT Research Group: The effect of inten- JA, Vincent M, Tamborlane WV: A random- Diabetes Educ 35 (Suppl. 2):29S–41S, 2009 ized, prospective trial comparing the efficacy sive treatment of diabetes on the development of continuous subcutaneous insulin infusion and progression of long-term complications in with multiple daily injection using insulin insulin dependent diabetes mellitus. N Engl J glargine. Diabetes Care 27:1554–1558, 2004 Med 329:977–986, 1993 Sara Wilson Reece, PharmD, 9Hirsch IB, Bode BW, Garg S, Lane WS, 13Bode BW, Davidson PC, Fredrickson LP, CDE, BC-ADM, is an assistant Sussman A, Hu P, Santiago OM, Kolaczynski Gross TM, Sabbah HT: Diabetes manage- professor of pharmacy practice at the JW: Continuous subcutaneous insulin infu- ment in the new millennium using insulin Philadelphia College of Osteopathic sion (CSII) of versus multiple pump therapy. Diabetes Metab Res Rev 18 daily injection of insulin aspart/insulin (Suppl. 1):S14–S20, 2002 Medicine, Georgia Campus, School glargine in type 1 diabetic patients previously of Pharmacy, in Suwanee, Ga. 14Nielson S, Kain D, Szukizik E, Dhindsa S, treated with CSII. Diabetes Care 28:533– She also provides diabetes clinical 538, 2005 Garg R, Dandona P: Use of continuous sub- cutaneous insulin infusion pump in patients services for The Longstreet Clinic 10Raskin P, Bode BW, Marks JB, Hirsch with type 2 diabetes mellitus. Diabetes Educ in Gainesville, Ga. Cheryl Lynn IB, Weinstein RL, McGill JB, Peterson GE, 31:843–848, 2005 Mudaliar SR, Reinhardt RR: Continuous Hamby Williams, RN, CDE, subcutaneous insulin infusion and mul- 15Wittlin S: Treating the spectrum of type 2 tiple daily injection therapy are equally diabetes: emphasis on insulin pump therapy. is a diabetes educator with The effective in type 2 diabetes: a randomized, Diabetes Educ 32:39S–46S, 2006 Longstreet Clinic.

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