6/9/2016

Lindsay McTavish MN, RN, CDE (NZ) Clinical Nurse Specialist ()

Charge Nurse Manager Endocrine, Diabetes & Research Centre Capital & Coast District Health Board Wellington New Zealand

Disclosure to Participants

Notice of Requirements For Successful Completion Please refer to learning goals and objectives Learners must attend the full activity and complete the evaluation in order to claim continuing Using a weight-based education credit/hours Conflict of Interest (COI) and Financial Relationship Disclosures: treatment protocol for pump Presenter: Lindsay McTavish: no conflict of interests Non-Endorsement of Products: therapy I have no product endorsements Off-Label Use: Nothing to declare

1 6/9/2016

Background to this study • Hypoglycemia treatment differs internationally • Limited ‘evidence based’ treatment methods • ISPAD, APEG, NICE, ADA & CDA recommend 5 - 20g simple CHO - followed by 10g of complex CHO for children • 15:15 rule for adults • 2007 – retest time 10 minutes

Slama, G. (1990) The Search for an Optimized Treatment of Hypoglycaemia: Carbohydrates in Tablets, Solution, or Gel for the Correction of Insulin Page 171 Reactions. Archives of Internal Medicine. Vol 150, March. ______15 grams of study treatment +54 Starch hydrosylate

Sucrose tablets Glucose tablets +36 Glucose solution -9 Sucrose solution ______+18 Glucose gel 125ml Orange juice +9

-9

Blood volume difference?

2 6/9/2016

Previous weight based studies

0.3 grams glucose/kg per treatment

Brodows, R.G, Williams C, Amatruda M. Treatment of insulin reactions in diabetics. JAMA 252:3378-81, 1984

International Recommendations

• < 4.0mmol/L or 72mmg/dL • Adults:15 grams glucose The WHiP study • Children: 10 grams glucose

(Weight-based Hypoglycemia treatment in Pumps study)

3 6/9/2016

Study rationale Hypothesis • Intensive therapy on CSII best….. Treatment of hypoglycemia in people with • Individualized treatment T1DM on insulin pumps, using a weight-based – Several basal rates treatment protocol of 0.3 grams glucose/kg of – Carbohydrate ratios body weight, is more effective in treating – Correction factors hypoglycemia without need for retreatment, – Set target compared to recommended international • So why not individualize hypo treatment? guidelines.

Study design Study protocol

Results Participant Characteristics Variable Mean (SD) Median (IQR) Min to Max Age (years) Adults N=20 38.4 (13.1) 39.1 (29.3 to 43.5) 17.5 to 67.8 • April 2014 – Dec 2015 Children N=15 11.4 (3.2) 11.7 (8.3 to 14.0) 6.1 to 16.1 BMI (kg/m2) Adults N=20 24.8 (3.8) 23.7 (22.8 to 34.9) 19.0 to 35.0 • 36 participants enrolled Children N=15 18.6 (2.3) 18.0 (17.4 to 19.0) 15.0 to 25.0 Height (cm) Adults N=20 169.9 (8.5) 170.1 (162.5 to 177.6) 157 to 186.4 • 1 withdrew Children N=15 152.2 (22.3) 152.7 (139.1 to 171.6) 119.0 to 186.4 Weight (kg) Adults N=20 72.2 (13.7) 68.7 (65.6 to 78.2) 54.8 to 116.2 • 20 adults and 15 children Children N=15 44.6 (16.6) 41.3 (35.2 to 52.9) 22.4 to 75.4 HbA1c (mmol/mol) • SAS version 9.4 Adults N=20 61.4 (15.8) 59.0 (47.5 to 73.5) 37 to 90 Children N=15 57.4 (7.2) 59 (50 to 63) 44 to 67 Male Sex N (%) Adults N=20 9 (45) Children N=15 11 (73.3)

4 6/9/2016

Number of treatments Blood glucose > 72 mg/dL Adult Variable Mean (SD) Median (IQR) Min to Max Blood glucose greater than 72 mg/dL (4 mmol/L) Total number of episodes of hypoglycemia Number of first Episode NOT Episode resolved Adults N=20 7.5 (3.7) 10 (4 to 10) 1 to 10 treatments resolved Children N=15 9.3 (1.6) 10 (10 to 10) 5 to 10 Control N=67 27 (40.3%) 40 (59.7%) Weight-based N=77 14 (18.2%) 63 (81.8%) Treatment counts

Adults Child Control N=19 3.7 (1.6) 4 (2 to 5) 1 to 5 Blood glucose greater than 72 mg/dL (4 mmol/L) Weight-based Number of first Episode NOT 4.6 (1.3) 5 (5 to 5) 1 to 6 Episode resolved N=17 treatments resolved Children Control N=69 26 (37.7%) 43 (62.3%) Control N=15 4.7 (1.1) 5 (5 to 5) 2 to 6 Weight-based N=69 13 (18.8%) 56 (81.2%) Weight-based 4.7 (0.6) 5 (4 to 5) 3 to 5 N=15

Response to treatment Change in glucose - Adults 360 mg/dL Estimates of treatment differences (by linear mixed model)

Glucose weight-based minus 270 mg/dL control P Key Estimate (95% CI) C= control Adults W= weight based Time 10 0.33 (0.005 to 0.66) 0.047* 180 mg/dL Time 20 0.78 (-0.02 to 1.57) 0.055 Time 30 1.28 (0.57 to 1.99) <0.001* 90 mg/dL Children Time 10 0.45 (0.18 to 0.72) 0.001* Time 20 0.15 (-0.62 to 0.91) 0.7 Time 30 0.44 (-0.47 to 1.35) 0.34 Time * A significant difference between the groups

Change in glucose - Children Treatment differences 360 mg/dL Estimates of odds ratios for blood glucose greater than 72 mg/dL or 4.0mmol/L 270 mg/dL Comparison Odds ratio (95% CI) P Key Adults 3.12 (1.38 to 7.02) 0.007* C= control 180 mg/dL W= weight based Children 2.61 (1.19 to 5.74) 0.017* * A significant difference between the groups

90 mg/dL

Time

5 6/9/2016

Summary Conclusion • Adults - Strong evidence at 30 minutes Using a weight-based treatment protocol of 0.3 - 23.4mg/dL (1.3mmol/L) higher grams glucose/kg is an effective method for • Children treating hypoglycemia in people with T1DM on - Strong evidence bgl’s were higher at 10 minutes insulin pumps - 9 mg/dL (0.5mmol/L) higher • a higher proportion of both adults and children resolved their episode with one treatment

Acknowledgements NZSSD for the study grant

6