Mary B Abraham1,2, Raymond Davey2,3, Michael J O'Grady1,3, Trang T Ly1,2,3, Nirubasini Paramalingam1,3, Paul A Fournier4, Anirban Roy5, Benyamin Grosman5, Natalie Kurtz5, Janice M Fairchild6, Bruce R King7, Geoffrey R Ambler8, Fergus Cameron9, Timothy W Jones1,2,3, Elizabeth A Davis1,2,3. 1. 1 Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children , Perth, Australia . 2. 2 School of Paediatrics and Child Health, The University of Western Australia , Perth, Australia . 3. 3 Telethon Kids Institute, The University of Western Australia , Perth, Australia . 4. 4 School of Sport Science, Exercise and Health, The University of Western Australia , Perth, Australia . 5. 5 Medtronic MiniMed , Northridge, California. 6. 6 Department of Endocrinology and Diabetes, Women's and Children's Hospital , Adelaide, Australia . 7. 7 Department of Endocrinology and Diabetes, John Hunter Children's Hospital , Newcastle, Australia . 8. 8 Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, The University of Sydney , Sydney, Australia . 9. 9 Department of Endocrinology and Diabetes, Royal Children's Hospital , Melbourne, Australia .
Abstract
BACKGROUND:Sensor-augmented pump therapy (SAPT) with a predictive algorithm to suspend insulin delivery has the potential to reduce hypoglycemia, a known obstacle in improving physical activity in patients with type 1 diabetes. The predictive low glucose management (PLGM) system employs a predictive algorithm that suspends basal insulin when hypoglycemia is predicted. The aim of this study was to determine the efficacy of this algorithm in the prevention of exercise-induced hypoglycemia under in-clinic conditions. METHODS: This was a randomized, controlled cross-over study in which 25 participants performed 2 consecutive sessions of 30 min ofmoderate-intensity exercise while on basal continuous subcutaneous insulin infusion on 2 study days: a control day with SAPT alone and an intervention day with SAPT and PLGM. The predictive algorithm suspended basal insulin when sensor glucose was predicted to be below the preset hypoglycemic threshold in 30 min. We tested preset hypoglycemic thresholds of 70 and 80 mg/dL. The primary outcome was the requirement for hypoglycemia treatment (symptomatic hypoglycemia with plasma glucose <63 mg/dL or plasma glucose <50 mg/dL) and was compared in both control and intervention arms. RESULTS: Results were analyzed in 19 participants. In the intervention arm with both thresholds, only 6 participants (32%) required treatment for hypoglycemia compared with 17 participants (89%) in the control arm (P = 0.003). In participants with a 2-h pump suspension on intervention days, the plasma glucose was 84 ± 12 and 99 ± 24 mg/dL at thresholds of 70 and 80 mg/dL, respectively. CONCLUSIONS:SAPT with PLGM reduced the need for hypoglycemia treatment after moderate-intensity exercise in an in-clinic setting.
RCT Entities:
BACKGROUND: Sensor-augmented pump therapy (SAPT) with a predictive algorithm to suspend insulin delivery has the potential to reduce hypoglycemia, a known obstacle in improving physical activity in patients with type 1 diabetes. The predictive low glucose management (PLGM) system employs a predictive algorithm that suspends basal insulin when hypoglycemia is predicted. The aim of this study was to determine the efficacy of this algorithm in the prevention of exercise-induced hypoglycemia under in-clinic conditions. METHODS: This was a randomized, controlled cross-over study in which 25 participants performed 2 consecutive sessions of 30 min of moderate-intensity exercise while on basal continuous subcutaneous insulin infusion on 2 study days: a control day with SAPT alone and an intervention day with SAPT and PLGM. The predictive algorithm suspended basal insulin when sensor glucose was predicted to be below the preset hypoglycemic threshold in 30 min. We tested preset hypoglycemic thresholds of 70 and 80 mg/dL. The primary outcome was the requirement for hypoglycemia treatment (symptomatic hypoglycemia with plasma glucose <63 mg/dL or plasma glucose <50 mg/dL) and was compared in both control and intervention arms. RESULTS: Results were analyzed in 19 participants. In the intervention arm with both thresholds, only 6 participants (32%) required treatment for hypoglycemia compared with 17 participants (89%) in the control arm (P = 0.003). In participants with a 2-h pump suspension on intervention days, the plasma glucose was 84 ± 12 and 99 ± 24 mg/dL at thresholds of 70 and 80 mg/dL, respectively. CONCLUSIONS:SAPT with PLGM reduced the need for hypoglycemia treatment after moderate-intensity exercise in an in-clinic setting.
Authors: Jane L Chiang; David M Maahs; Katharine C Garvey; Korey K Hood; Lori M Laffel; Stuart A Weinzimer; Joseph I Wolfsdorf; Desmond Schatz Journal: Diabetes Care Date: 2018-08-09 Impact factor: 19.112