scholarly journals Faster insulin action is associated with improved glycaemic outcomes during closed-loop insulin delivery and sensor-augmented pump therapy in adults with type 1 diabetes

2017 ◽  
Vol 19 (10) ◽  
pp. 1485-1489 ◽  
Author(s):  
Yue Ruan ◽  
Hood Thabit ◽  
Lalantha Leelarathna ◽  
Sara Hartnell ◽  
Malgorzata E. Wilinska ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Insulin Action ◽  
Closed Loop ◽  
Insulin Delivery ◽  
Pump Therapy

scholarly journals Improved Glycemic Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop Delivery: Results From a Randomized Crossover Trial Comparing Automated Insulin Delivery With Predictive Low Glucose Suspend in People With Type 1 Diabetes

2021 ◽  
Author(s):  
Olivia J Collyns ◽  
Renee A Meier ◽  
Zara L Betts ◽  
Denis SH Chan ◽  
Chris Frampton ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Insulin Delivery ◽  
Target Range ◽  
Study Phase ◽  
Pump Therapy ◽  
Set Point ◽  
Sensor Glucose ◽  
Low Glucose

Objective:<br><p> To study the MiniMed™ Advanced Hybrid Closed-Loop system (AHCL) which includes an algorithm with individualised basal target set points, automated correction bolus function, and improved Auto Mode stability.<br> Research design and Methods:</p> <p>This dual-centre, randomized, open-label, two-sequence cross-over study in automated insulin delivery naïve participants with type 1 diabetes (aged 7-80yrs), compared AHCL to Sensor Augmented Pump therapy with Predictive Low Glucose Management (SAP+PLGM). Each study phase was 4 weeks, preceded by a 2-4 week run-in, and separated by 2-week washout.</p> <p><a>Results:<b> </b><br> 59/60 people completed the study (mean age 23.3±14.4yrs). Time in target range (TIR) 3.9-10mmol/L (70-180 mg/dL) favoured AHCL over SAP+PLGM (</a>70.4±8.1 vs 57.9±11.7) by 12.5±8.5% (p<0.001), with greater improvement overnight (18.8±12.9%, p<0.001). All age groups (children (7 – 13 years), adolescents (14 – 21 years), and adults (>22 years) demonstrated improvement, with adolescents showing the largest improvement (14.4±8.4%). Mean sensor glucose (SG) at run in was 9.3±0.9 mmol/L (167±16.2mg/dL) and improved with AHCL (8.5±0.7mmol/L (153±12.6mg/dL) (p < 0.001)), but deteriorated during PLGM (9.5±1.1mmol/L (17±19.8mg/dL), (p<0.001)).. TIR was optimal when the algorithm set point was 5.6 mmol/L (100 mg/dL) compared to 6.7 mmol/L (120 mg/dL), 72.0±7.9% vs 64.6±6.9% respectively with no additional hypoglycemia. Auto Mode was active 96.4±4.0% of the time. <a>The percentage of hypoglycemia at baseline (<3.9mmol/L (70mg/dl) and </a> £ 3.0mmol/L(54mg/dl)) was 3.1±2.1% and 0.5±0.6% respectively. During AHCL percentage time <3.9mmol/L (70mg/dl) improved to 2.1±1.4% (p=0.034) (70mg/dl), and was statistically but not clinically reduced for £ 3.0mmol/L(54mg/dl) (0.5±0.5%, p = 0.025) There was one episode of mild diabetic ketoacidosis attributed to an infusion set failure in combination with an intercurrent illness, which occurred during the SAP+PLGM arm.</p> <p>Conclusions</p> <p>AHCL with automated correction bolus demonstrated significant improvement in glucose control compared to SAP+PLGM. A lower algorithm sensor glucose set point during AHCL resulted in greater TIR, with no increase in hypoglycemia.</p>

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

scholarly journals Assessing the efficacy, safety and utility of 6-month day-and-night automated closed-loop insulin delivery under free-living conditions compared with insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, multicentre, multinational, single-period, randomised, parallel group study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e027856 ◽  
Author(s):  
Gianluca Musolino ◽  
Janet M Allen ◽  
Sara Hartnell ◽  
Malgorzata E Wilinska ◽  
Martin Tauschmann ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Children And Adolescents ◽  
Closed Loop ◽  
Insulin Pump ◽  
Insulin Delivery ◽  
Open Label ◽  
Pump Therapy ◽  
Glucose Levels ◽  
Sensor Glucose

IntroductionClosed-loop systems titrate insulin based on sensor glucose levels, providing novel means to reduce the risk of hypoglycaemia while improving glycaemic control. We will assess effectiveness of 6-month day-and-night closed-loop insulin delivery compared with usual care (conventional or sensor-augmented pump therapy) in children and adolescents with type 1 diabetes.Methods and analysisThe trial adopts an open-label, multicentre, multinational (UK and USA), randomised, single-period, parallel design. Participants (n=130) are children and adolescents (aged ≥6 and <19 years) with type 1 diabetes for at least 1 year, and insulin pump use for at least 3 months with suboptimal glycaemic control (glycated haemoglobin ≥58 mmol/mol (7.5%) and ≤86 mmol/mol (10%)). After a 2–3 week run-in period, participants will be randomised to 6-month use of hybrid closed-loop insulin delivery, or to usual care. Analyses will be conducted on an intention-to-treat basis. The primary outcome is glycated haemoglobin at 6 months. Other key endpoints include time in the target glucose range (3.9–10 mmol/L, 70–180 mg/dL), mean sensor glucose and time spent above and below target. Secondary outcomes include SD and coefficient of variation of sensor glucose levels, time with sensor glucose levels <3.5 mmol/L (63 mg/dL) and <3.0 mmol/L (54 mg/dL), area under the curve of glucose <3.5 mmol/L (63 mg/dL), time with glucose levels >16.7 mmol/L (300 mg/dL), area under the curve of glucose >10.0 mmol/L (180 mg/dL), total, basal and bolus insulin dose, body mass index z-score and blood pressure. Cognitive, emotional and behavioural characteristics of participants and caregivers and their responses to the closed-loop and clinical trial will be assessed. An incremental cost-effectiveness ratio for closed-loop will be estimated.Ethics and disseminationCambridge South Research Ethics Committee and Jaeb Center for Health Research Institutional Review Office approved the study. The findings will be disseminated by peer-review publications and conference presentations.Trial registration numberNCT02925299; Pre-results.

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 Improved Glycemic Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop Delivery: Results From a Randomized Crossover Trial Comparing Automated Insulin Delivery With Predictive Low Glucose Suspend in People With Type 1 Diabetes

2021 ◽  
Author(s):  
Olivia J Collyns ◽  
Renee A Meier ◽  
Zara L Betts ◽  
Denis SH Chan ◽  
Chris Frampton ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Insulin Delivery ◽  
Target Range ◽  
Study Phase ◽  
Pump Therapy ◽  
Set Point ◽  
Sensor Glucose ◽  
Low Glucose

Objective:<br><p> To study the MiniMed™ Advanced Hybrid Closed-Loop system (AHCL) which includes an algorithm with individualised basal target set points, automated correction bolus function, and improved Auto Mode stability.<br> Research design and Methods:</p> <p>This dual-centre, randomized, open-label, two-sequence cross-over study in automated insulin delivery naïve participants with type 1 diabetes (aged 7-80yrs), compared AHCL to Sensor Augmented Pump therapy with Predictive Low Glucose Management (SAP+PLGM). Each study phase was 4 weeks, preceded by a 2-4 week run-in, and separated by 2-week washout.</p> <p><a>Results:<b> </b><br> 59/60 people completed the study (mean age 23.3±14.4yrs). Time in target range (TIR) 3.9-10mmol/L (70-180 mg/dL) favoured AHCL over SAP+PLGM (</a>70.4±8.1 vs 57.9±11.7) by 12.5±8.5% (p<0.001), with greater improvement overnight (18.8±12.9%, p<0.001). All age groups (children (7 – 13 years), adolescents (14 – 21 years), and adults (>22 years) demonstrated improvement, with adolescents showing the largest improvement (14.4±8.4%). Mean sensor glucose (SG) at run in was 9.3±0.9 mmol/L (167±16.2mg/dL) and improved with AHCL (8.5±0.7mmol/L (153±12.6mg/dL) (p < 0.001)), but deteriorated during PLGM (9.5±1.1mmol/L (17±19.8mg/dL), (p<0.001)).. TIR was optimal when the algorithm set point was 5.6 mmol/L (100 mg/dL) compared to 6.7 mmol/L (120 mg/dL), 72.0±7.9% vs 64.6±6.9% respectively with no additional hypoglycemia. Auto Mode was active 96.4±4.0% of the time. <a>The percentage of hypoglycemia at baseline (<3.9mmol/L (70mg/dl) and </a> £ 3.0mmol/L(54mg/dl)) was 3.1±2.1% and 0.5±0.6% respectively. During AHCL percentage time <3.9mmol/L (70mg/dl) improved to 2.1±1.4% (p=0.034) (70mg/dl), and was statistically but not clinically reduced for £ 3.0mmol/L(54mg/dl) (0.5±0.5%, p = 0.025) There was one episode of mild diabetic ketoacidosis attributed to an infusion set failure in combination with an intercurrent illness, which occurred during the SAP+PLGM arm.</p> <p>Conclusions</p> <p>AHCL with automated correction bolus demonstrated significant improvement in glucose control compared to SAP+PLGM. A lower algorithm sensor glucose set point during AHCL resulted in greater TIR, with no increase in hypoglycemia.</p>

1065-P: The Effect of a Closed-Loop Insulin Delivery System on Glycemic Control in Type 1 Diabetes

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 1065-P ◽  
Author(s):  
ANASTASIOS KOUTSOVASILIS ◽  
ALEXIOS SOTIROPOULOS ◽  
ANASTASIA ANTONIOU ◽  
VASILIOS KORDINAS ◽  
DESPINA PAPADAKI ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Delivery System ◽  
Closed Loop ◽  
Insulin Delivery ◽  
Insulin Delivery System

725-P: Reducing Hypoglycemic Risk during Postprandial Exercise with Closed-Loop Insulin Delivery in Adults with Type 1 Diabetes: Announced and Unannounced Exercise

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 725-P
Author(s):  
SEMAH TAGOUGUI ◽  
NADINE TALEB ◽  
CORINNE SUPPERE ◽  
INÈS BOUKABOUS ◽  
VIRGINIE MESSIER ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Insulin Delivery
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