Predictors of glycemic control with the clinical use

Predictors of glycemic control with the clinical use of the Mini. Med™ 670 G hybrid closed-loop insulin delivery system in children, adolescents, and young adults with type 1 diabetes. Maggie Daseler PGY-1 Pharmacy Resident Children’s Minnesota- St. Paul

Learning Objectives 1. Understand the mechanisms of the Mini. Med 670 G pump including the Auto Mode and suspend before low function. 2. Discuss the efficacy and safety of Mini. Med 670 G for tight glucose control. 3. Assess the long-term adherence of the Mini. Med 670 G insulin pump. © 2019 2

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Mini. Med™ 670 G Pump • Closed-loop hybrid insulin delivery system • First insulin pump with Auto Mode feature • Monitors blood glucose every 5 minutes and adjusts insulin basal rate • Suspend Before Low • Discontinues insulin prior to reaching a preset low threshold © 2019 4

Methods • Retrospective Chart Review • Performed at Children’s Minnesota Mc. Neely Pediatric Diabetes Center • Extension Study • Data was collected up to 96 weeks after initiation of the Mini. Med™ 670 G system © 2019 5

Endpoints Primary Outcomes Secondary Outcomes § Average A 1 c § Percent Above Range (≥ 180 mg/d. L) § Percent In Range (70 -180 mg/d. L) § Percent Below Range (≤ 70 mg/d. L) § Percent time using Auto Mode (per week) § Average blood glucose (BG) § Average sensor glucose (SG) © 2019 6

Criteria • Inclusion Criteria • Patients initiating insulin pump therapy with the Mini. Med 670 G between 3/1/17 – 11/10/18 • Patient is aged 4 -25 years old at time of 670 G initiation • Patient is clinically diagnosed with Type 1 Diabetes Mellitus • Patient had a clinic visit and seen in person by a provider in Mc. Neely Diabetes Center • Exclusion Criteria • Patient is clinically diagnosed with Type 2 Diabetes Mellitus • Patient declined research participation initial intake form © 2019 7

Preliminary Results

Group Classifications • Users: Had data 8 out of 10 timepoints • n=30 • Non-Users: Data less than 8 out of 10 timepoints • N=39 • Due to poor adherence or discontinuation of Mini. Med 670 G insulin delivery system • Total n=69 © 2019 9

Demographics and Associations with Consistent Use Demographics Percent Total Consistent Users Gender Non-Consistent Users 0. 6566 Male 46. 38% 40. 63% 59. 28% Female 53. 62% 54. 05% 45. 95% Age © 2019 P-Value 0. 0017 5 -13 years 33. 33% 65. 22% 34. 78% 14 -17 years 30. 43% 52. 38% 47. 62% 18 -25 years 36. 23% 16. 00% 25. 64% 10

Demographics and Associations with Consistent Use Demographics Percent Total Consistent Users Non-Consistent Users BMI 0. 4843 Normal Weight 59. 42% 43. 90% 56. 10% Overweight 21. 74% 53. 33% 46. 67% Obese 30. 77% 69. 23% 18. 84% Baseline A 1 c © 2019 P-Value 0. 2619 ≤ 7. 5 26. 09% 44. 44% 55. 56% 7. 5 -8. 4 47. 83% 51. 52% 48. 48% ≥ 8. 4 26. 09% 27. 78% 72. 22% 11

Percent Time in Auto Mode Percent of Total Patients Using Auto Mode By Week 100 90 80 70 60 50 40 30 20 10 0 0 © 2019 2 4 8 12 16 Weeks 20 24 36 48 60 12

Percent Time in Auto Mode Average % Time in Auto Mode for Consistent Users 100 90 80 70 60 50 40 30 20 10 0 P-Value = 0. 0057 2 © 2019 4 8 12 16 20 Weeks 24 36 48 60 13

A 1 c Change in A 1 C from 0 to 60 weeks 8. 8 8. 6 8. 4 8. 2 8 7. 6 7. 4 7. 2 7 P-value = 0. 0008 Non-users Users 0 weeks © 2019 60 weeks 14

Percent Time in Range Percent Time Blood Glucose in Range (70 -180 mg/d. L) for Consistent Users 100 90 80 70 60 50 40 30 20 10 0 P-value <0. 001 0 © 2019 2 4 8 12 16 Weeks 20 24 36 48 60 15

Percent Time Above Range Percent Time Blood Glucose Above Range (≥ 180 mg/d. L) for Consistent Users 100 90 80 70 60 50 40 30 20 10 0 P-Value <0. 0001 0 © 2019 2 4 8 12 16 Weeks 20 24 36 48 60 16

Percent Time Below Range Percent Time Blood Glucose Below Range (≤ 70 mg/d. L) for Consistent Users 100 90 80 70 60 50 40 30 20 10 0 P-value 0. 1748 0 © 2019 2 4 8 12 16 Weeks 20 24 36 48 60 17

Conclusions • Consistent use of Mini. Med™ 670 G decreased A 1 c • Consistent use of Mini. Med™ 670 G increased % time in range • These were statistically significant findings • Data will continue to be collected analyzed up to 96 weeks from baseline © 2019 18

Acknowledgements • • © 2019 Laura Gandrud, MD Carlo Henson, Pharm. D Amanda Nickel David Watson 19

Questions © 2019 20

References 1. 2. 3. 4. © 2019 Tauschmann M, Thabit H, Bally L, et al. Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicenter, 12 -week randomized trial. Lancet 2018; 392: 1321 -29. De Bock M, Mc. Auley SA, Abraham MB, et al. Effect of 6 months hybrid closedloop insulin delivery in young people with type 1 diabetes: a randomized controlled trial protocol. BMJ Open 2018; 8: 1 -8. Aleppo G, Webb KM. Integrated insulin pump and continuous glucose monitoring technology in diabetes care today: a perspective of real-life experience with the Minimed™ 670 G hybrid closed-loop system. Endocrin Practice. July 2018; 24(7): 684 -692. Boughton CK, Hovorka R. Is an artificial pancreas (closed-loop system) for Type 1 diabetes effective? Diabetes UK. September 2018; 1 -8. 21