scholarly journals Closed-Loop Insulin Delivery Versus Sensor-Augmented Pump Therapy in Older Adults With Type 1 Diabetes (ORACL): A Randomized, Crossover Trial

Diabetes Care ◽  
2021 ◽  
pp. dc211667
Author(s):  
Sybil A. McAuley ◽  
Steven Trawley ◽  
Sara Vogrin ◽  
Glenn M. Ward ◽  
Spiros Fourlanos ◽  
...  
Keyword(s):  
Older Adults ◽  
Type 1 Diabetes ◽  
Closed Loop ◽  
Crossover Trial ◽  
Insulin Delivery ◽  
Pump Therapy ◽  
Randomized Crossover Trial

212-OR: Closed-Loop Increases Time-in-Range in Older Adults with Type 1 Diabetes Compared with Sensor-Augmented Pump Therapy: A Randomized Crossover Trial

Diabetes ◽  
2021 ◽  
Vol 70 (Supplement 1) ◽  
pp. 212-OR
Author(s):  
SYBIL A. MCAULEY ◽  
SARA VOGRIN ◽  
STEVEN TRAWLEY ◽  
PETER G. COLMAN ◽  
SPIROS FOURLANOS ◽  
...  
Keyword(s):  
Older Adults ◽  
Type 1 Diabetes ◽  
Closed Loop ◽  
Crossover Trial ◽  
Pump Therapy ◽  
Randomized Crossover Trial ◽  
Time In Range

scholarly journals Closed-Loop Insulin Delivery Versus Sensor-Augmented Pump Therapy in Older Adults With Type 1 Diabetes (ORACL): A Randomized, Crossover Trial

2021 ◽  
Author(s):  
Sybil A McAuley ◽  
Steven Trawley ◽  
Sara Vogrin ◽  
Glenn M Ward ◽  
Spiros Fourlanos ◽  
...  
Keyword(s):  
Older Adults ◽  
Type 1 Diabetes ◽  
Closed Loop ◽  
Crossover Trial ◽  
Insulin Delivery ◽  
Diabetes Duration ◽  
Pump Therapy ◽  
Percentage Points ◽  
Pump Stage

Objective <p>To assess the efficacy and safety of closed-loop insulin delivery compared with sensor-augmented pump therapy among older adults with type 1 diabetes.</p> <h2>Research Design and Methods</h2> <p>This open-label randomized (1:1), crossover trial compared 4 months of closed-loop versus sensor-augmented pump therapy. Eligible adults were aged ≥60 years, with type 1 diabetes (duration ≥10 years), using an insulin pump. The primary outcome was continuous glucose monitoring (CGM) time in range <a>(TIR; 3.9–10.0 mmol/L</a>).</p> <h2>Results</h2> <p>Thirty participants (mean age 67 years [SD 5]; median type 1 diabetes duration 38 years [IQR 20–47]) were randomized, <i>n</i>=15 to each sequence; all completed the trial. The mean TIR was 75.2% (6.3) during the closed-loop stage and 69.0% (9.1) during the sensor-augmented pump stage (difference 6.2 percentage points [95% CI 4.4, 8.0]; <i>P</i> <0.0001). All prespecified CGM metrics favored closed loop over sensor-augmented pump; benefits were greatest overnight. Closed loop reduced CGM time <3.9 mmol/L during 24 h/day by 0.5 percentage points (0.3, 1.1; <i>P</i> = 0.0005) and overnight by 0.8 percentage points (0.4, 1.1; <i>P</i> <0.0001) compared with sensor-augmented pump. There was no significant difference in HbA<sub>1c</sub> between closed-loop versus sensor-augmented pump stages (7.3% [7.1–7.5] | 56 mmol/mol [54–59] versus 7.5% [7.1–7.9] | 59 mmol/mol [54–62], respectively; <i>P</i> = 0.13). Three severe hypoglycemia events occurred during the closed-loop stage and two occurred during the sensor-augmented pump stage; no hypoglycemic events required hospitalization. One episode of diabetic ketoacidosis occurred during the sensor-augmented pump stage; no serious adverse events occurred during the closed-loop stage.</p> <h2>Conclusion</h2> <p>Closed-loop therapy is an effective treatment option for older adults with long duration type 1 diabetes and no safety issues were identified. These older adults had higher TIR accompanied by less time below range during closed-loop than sensor-augmented pump therapy. Of particular clinical importance, closed loop reduced the time spent in hypoglycemic range overnight. </p>

scholarly journals Closed-Loop Insulin Delivery Versus Sensor-Augmented Pump Therapy in Older Adults With Type 1 Diabetes (ORACL): A Randomized, Crossover Trial

2021 ◽  
Author(s):  
Sybil A McAuley ◽  
Steven Trawley ◽  
Sara Vogrin ◽  
Glenn M Ward ◽  
Spiros Fourlanos ◽  
...  
Keyword(s):  
Older Adults ◽  
Type 1 Diabetes ◽  
Closed Loop ◽  
Crossover Trial ◽  
Insulin Delivery ◽  
Diabetes Duration ◽  
Pump Therapy ◽  
Percentage Points ◽  
Pump Stage

Objective <p>To assess the efficacy and safety of closed-loop insulin delivery compared with sensor-augmented pump therapy among older adults with type 1 diabetes.</p> <h2>Research Design and Methods</h2> <p>This open-label randomized (1:1), crossover trial compared 4 months of closed-loop versus sensor-augmented pump therapy. Eligible adults were aged ≥60 years, with type 1 diabetes (duration ≥10 years), using an insulin pump. The primary outcome was continuous glucose monitoring (CGM) time in range <a>(TIR; 3.9–10.0 mmol/L</a>).</p> <h2>Results</h2> <p>Thirty participants (mean age 67 years [SD 5]; median type 1 diabetes duration 38 years [IQR 20–47]) were randomized, <i>n</i>=15 to each sequence; all completed the trial. The mean TIR was 75.2% (6.3) during the closed-loop stage and 69.0% (9.1) during the sensor-augmented pump stage (difference 6.2 percentage points [95% CI 4.4, 8.0]; <i>P</i> <0.0001). All prespecified CGM metrics favored closed loop over sensor-augmented pump; benefits were greatest overnight. Closed loop reduced CGM time <3.9 mmol/L during 24 h/day by 0.5 percentage points (0.3, 1.1; <i>P</i> = 0.0005) and overnight by 0.8 percentage points (0.4, 1.1; <i>P</i> <0.0001) compared with sensor-augmented pump. There was no significant difference in HbA<sub>1c</sub> between closed-loop versus sensor-augmented pump stages (7.3% [7.1–7.5] | 56 mmol/mol [54–59] versus 7.5% [7.1–7.9] | 59 mmol/mol [54–62], respectively; <i>P</i> = 0.13). Three severe hypoglycemia events occurred during the closed-loop stage and two occurred during the sensor-augmented pump stage; no hypoglycemic events required hospitalization. One episode of diabetic ketoacidosis occurred during the sensor-augmented pump stage; no serious adverse events occurred during the closed-loop stage.</p> <h2>Conclusion</h2> <p>Closed-loop therapy is an effective treatment option for older adults with long duration type 1 diabetes and no safety issues were identified. These older adults had higher TIR accompanied by less time below range during closed-loop than sensor-augmented pump therapy. Of particular clinical importance, closed loop reduced the time spent in hypoglycemic range overnight. </p>

scholarly journals Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Suboptimally Controlled Adolescents With Type 1 Diabetes: A 3-Week, Free-Living, Randomized Crossover Trial

Diabetes Care ◽  
2016 ◽  
Vol 39 (11) ◽  
pp. 2019-2025 ◽  
Author(s):  
Martin Tauschmann ◽  
Janet M. Allen ◽  
Malgorzata E. Wilinska ◽  
Hood Thabit ◽  
Carlo L. Acerini ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Crossover Trial ◽  
Insulin Delivery ◽  
Free Living ◽  
Randomized Crossover Trial
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