To Pump OR To Inject … that is the Question … ? Sanoe Harrison & Patrick Hanley

Autoimmune Diabetes Mellitus Review of Problem

Glucose in Healthy Volunteers Day Ave ± SD = 93.0 ± 7.0 mg/dl, Night Ave ± SD = 81.8 ± 6.3 mg/dl

DCCT (Diabetes Control and Complication Trial)

Goals for long term health … A1c < 7.5 Absence of severe hypoglycemia Minimize glucose variability … Normal blood pressure Normal cholesterol (LDL & HDL) Normal weight (BMI <85th percentile for age & sex)

Insulin Discovery

First insulin syringe 1949 First glucometer 1968

1963 - Dr. Arnold Kadish designed the first insulin pump to be worn as a backpack First marketable pump available in 1976

Sanoe’s Story Who are we: quick personal diabetes history (age of diagnosis, selection of MDI, etc) Engage crowd – make it personal but to help in relation to crowd

Sanoe’s Timeline 13 diagnosed with T1D used NPH and Regular 16 began to use Humalog and Ultralente 21 began to use insulin pump 35 began to use glucose sensor

Pat’s Story Talk about initial experience with glucometer and getting diagnosed – improvement in diagnosis Then quick timeline on diabetes history Who are we: quick personal diabetes history (age of diagnosis, selection of MDI, etc) Engage crowd – make it personal but to help in relation to crowd

Pat’s Timeline

Discussion Questions … What made you choose this breakout session? Who uses a pump for insulin? Who uses MDI for insulin? Engage crowd - Try to identify why they chose this session to address questions as we go through

Is there research to help us decide … ? We all know the first key is … taking our insulin and checking our blood sugar! But the question is … with more options today to deliver insulin and monitor glucose is one way better? Evidence based medicine but also need to consider … … what is best for you the individual patient/family?

Some Articles Comparing CSII to MDI “Long-term health economic benefits of sensor- augmented pump therapy vs continuous subcutaneous insulin infusion alone in type 1 diabetes: a UK perspective” - Journal of Medical Economics 2016 “Continuous subcutaneous insulin infusion therapy and multiple daily insulin injections in type 1 diabetes mellitus: a comparative overview and future horizons” - Expert Opinion on Drug Delivery 2015 “Multiple Daily Injections OR Insulin Pump Therapy: Choosing the Best Option for Your Patient—An Evidence-based Approach” – Current Diabetes Reports 2015 “Does treatment with an insulin pump improve glycaemic control in children and adolescents with type 1 diabetes? A retrospective case–control study” - Pediatric Diabetes 2015

Articles Comparing CSII to MDI “Insulin pump therapy, multiple daily injections, and cardiovascular mortality in 18,168 people with type 1 diabetes: observational study” – British Medical Journal 2015 “Insulin pump use in young children in the T1D Exchange clinic registry is associated with lower hemoglobin A1c levels than injection therapy” - Pediatric Diabetes 2014 “Long-term outcome of insulin pump therapy in children with type 1 diabetes assessed in a large population-based case–control study” –Diabetologia 2013 “A randomized, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine“– Diabetes Care 2004

NGSP HbA1c
 (%) IFCC HbA1c (mmol/mol) 5.0 31 97 6.0 42 126 7.0 53 154 8.0 64 183 9.0 75 212 10.0 86 240 11.0 97 269 12.0 108 298  

Major findings of this paper Showed that treatment with CSII resulted in an improvement in HbA1c levels up to 1 year (8.1% vs. 8.3%)  # of severe hypoglycaemic events with CSII = incidence rates of severe hypoglycaemic episodes per 100 person-years were 3 in the CSII group & 6 in the MDI group Frequency of ketoacidosis  in CSII group = There were 2.8 episodes of DKA/100 person-years in the CSII group & 0.5 in the MDI group  insulin needed in CSII group & no change in weight At 6 months 7.8% vs 8.4% with CSII 216 patients in CSII group and 215 in MDI group

Why do some people stop using pumps? Main reasons found in one study: Greater sense of disease (93%) Difficulties in doing sports (70%) Worse well-being during pump therapy (63%) Having to attach the pump to the body (60%) Embarrassment (56%) Adhesions & pain in the place of needle insertion (50%) Difficulties in controlling glycemia during physical exercise (43%) Fear (43%) High levels of HbA1c (36%) Frequent blood glucose monitoring (26%) “Reasons for the discontinuation of therapy of personal insulin pump in children with type 1 diabetes” Pediatr Endocrinol Diabetes Metab 2015;21,2:65-69 Not common … only about 4% of people that start CSII return to MDI One study looked at 30 children who started using CSII & then stopped No problems with technical operation of the pump or frequent episodes of severe hypoglycemia or ketoacidosis were reported

Pros & Cons of Pumps Pros Cons Flexible basal rates Advanced bolus options Convenience of giving multiple doses Slightly decreased total insulin need Cons Risk of DKA with pump malfunction Hardware attached to body Cost

Pros & Cons of MDI Pros Cons Reliable absorption Not connected to device More affordable Cons Cannot alternate basal rates Multiple injections Harder to disguise

Special Considerations Image from: http://keralaeditor.com/kerala-to-provide-free-insulin-pumps-for-diabetic-kids/

Case 1 18 y/o F, got a pump 2yrs ago, and is now going away to college At school she is too busy to test sugar more than 2x per day She noticed that her pump insulin reservoir lasts her 5 days She usually gets home late, tests, changes her pump sites as needed right before going to bed

Case 2 14 year old boy on MDI since diagnosis 2 yrs ago Normally hyperglycemic in the morning despite changing lantus dose Hypoglycemia often with sports Very active with sports & motivated to do better with his diabetes control …

How do you define success with Diabetes? Tools to fit life Image or link

Future Directions

Affreza – Inhaled Insulin

Absorption

Afrezza – Side Effects Respiratory Decreased Lung function in some (6 vs. 3%) Cough ~25 % Cancer 4 cases of lung cancer (2 smokers) 2 years duration, a 15% or greater reduction in forced expiratory volume (FEV1) occurred in 6% of patients treated with inhaled insulin compared with a 3% decline in patients receiving comparator anti-diabetes treatment. Patients with chronic lung disease were not included in these studies. The FEV1 decline occurred during the first 3 months and persisted; it did not appear to worsen with increased duration of use. The changes in FEV1 were similar in patients with type 1 and type 2 diabetes mellitus.

Degludec

Degludec Pharmacokinetic properties: Long half-life (25 h) Long duration of action (42 h) Lower variability (25% that glarginie) from other basal analogues Need studies in pediatric patients …

Thank you very much for your attention & participation … any questions? A few more questions … Why did you choose your current therapy? Do you want to change? If so why?