Twelve-week 24/7 ambulatory artificial pancreas with weekly adaptation of insulin delivery settings: Effect on hemoglobin A1c and hypoglycemia

Eyal Dassau, Jordan E. Pinsker, Yogish C Kudva, Sue A. Brown, Ravi Gondhalekar, Chiara Dalla Man, Steve Patek, Michele Schiavon, Vikash Dadlani, Isuru Dasanayake, Mei Mei Church, Rickey E. Carter, Wendy C. Bevier, Lauren M. Huyett, Jonathan Hughes, Stacey Anderson, Dayu Lv, Elaine Schertz, Emma Emory, Shelly K. McCrady-SpitzerTyler Jean, Paige K. Bradley, Ling Hinshaw, Alejandro J. Laguna Sanz, Ananda Basu, Boris Kovatchev, Claudio Cobelli, Francis J. Doyle

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Objective: Artificial pancreas (AP) systems are best positioned for optimal treatment of type 1 diabetes (T1D) and are currently being tested in outpatient clinical trials. Our consortium developed and tested a novel adaptive AP in an outpatient, single-arm, uncontrolled multicenter clinical trial lasting 12 weeks. Research Design and Methods: Thirty adults with T1D completed a continuous glucose monitor (CGM)-augmented 1-week sensor-augmented pump(SAP) period. After the AP was started, basal insulin delivery settings used by the AP for initialization were adapted weekly, and carbohydrate ratios were adapted every 4 weeks by an algorithm running on a cloud-based server, with automatic data upload from devices. Adaptations were reviewed by expert study clinicians and patients. The primary end point was change in hemoglobin A1c (HbA1c). Outcomes are reported adhering to consensus recommendations on reporting of AP trials. Results: Twenty-nine patients completed the trial. HbA1c, 7.0 ± 0.8% at the start of AP use, improved to 6.7 ± 0.6% after 12 weeks (-0.3, 95% CI -0.5 to -0.2, P < 0.001). Compared with the SAP run-in, CGM time spent in the hypoglycemic range improved during the day from 5.0 to 1.9%(-3.1, 95% CI -4.1 to -2.1, P < 0.001) and overnight from 4.1 to 1.1% (-3.1, 95% CI -4.2 to -1.9, P < 0.001). Whereas carbohydrate ratios were adapted to a larger extent initially with minimal changes there after, basal insulin was adapted throughout. Approximately 10% of adaptation recommendations were manually overridden. There were no protocol-related serious adverse events. Conclusions: Use of our novel adaptive AP yielded significant reductions in HbA1c and hypoglycemia.

Original languageEnglish (US)
Pages (from-to)1719-1726
Number of pages8
JournalDiabetes Care
Volume40
Issue number12
DOIs
StatePublished - Dec 1 2017

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Artificial Pancreas
Hypoglycemia
Hemoglobins
Insulin
Type 1 Diabetes Mellitus
Outpatients
Carbohydrates
Clinical Trials
Glucose
Hypoglycemic Agents
Multicenter Studies
Research Design
Equipment and Supplies

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

Cite this

Twelve-week 24/7 ambulatory artificial pancreas with weekly adaptation of insulin delivery settings : Effect on hemoglobin A1c and hypoglycemia. / Dassau, Eyal; Pinsker, Jordan E.; Kudva, Yogish C; Brown, Sue A.; Gondhalekar, Ravi; Man, Chiara Dalla; Patek, Steve; Schiavon, Michele; Dadlani, Vikash; Dasanayake, Isuru; Church, Mei Mei; Carter, Rickey E.; Bevier, Wendy C.; Huyett, Lauren M.; Hughes, Jonathan; Anderson, Stacey; Lv, Dayu; Schertz, Elaine; Emory, Emma; McCrady-Spitzer, Shelly K.; Jean, Tyler; Bradley, Paige K.; Hinshaw, Ling; Laguna Sanz, Alejandro J.; Basu, Ananda; Kovatchev, Boris; Cobelli, Claudio; Doyle, Francis J.

In: Diabetes Care, Vol. 40, No. 12, 01.12.2017, p. 1719-1726.

Research output: Contribution to journalArticle

Dassau, E, Pinsker, JE, Kudva, YC, Brown, SA, Gondhalekar, R, Man, CD, Patek, S, Schiavon, M, Dadlani, V, Dasanayake, I, Church, MM, Carter, RE, Bevier, WC, Huyett, LM, Hughes, J, Anderson, S, Lv, D, Schertz, E, Emory, E, McCrady-Spitzer, SK, Jean, T, Bradley, PK, Hinshaw, L, Laguna Sanz, AJ, Basu, A, Kovatchev, B, Cobelli, C & Doyle, FJ 2017, 'Twelve-week 24/7 ambulatory artificial pancreas with weekly adaptation of insulin delivery settings: Effect on hemoglobin A1c and hypoglycemia', Diabetes Care, vol. 40, no. 12, pp. 1719-1726. https://doi.org/10.2337/dc17-1188
Dassau, Eyal ; Pinsker, Jordan E. ; Kudva, Yogish C ; Brown, Sue A. ; Gondhalekar, Ravi ; Man, Chiara Dalla ; Patek, Steve ; Schiavon, Michele ; Dadlani, Vikash ; Dasanayake, Isuru ; Church, Mei Mei ; Carter, Rickey E. ; Bevier, Wendy C. ; Huyett, Lauren M. ; Hughes, Jonathan ; Anderson, Stacey ; Lv, Dayu ; Schertz, Elaine ; Emory, Emma ; McCrady-Spitzer, Shelly K. ; Jean, Tyler ; Bradley, Paige K. ; Hinshaw, Ling ; Laguna Sanz, Alejandro J. ; Basu, Ananda ; Kovatchev, Boris ; Cobelli, Claudio ; Doyle, Francis J. / Twelve-week 24/7 ambulatory artificial pancreas with weekly adaptation of insulin delivery settings : Effect on hemoglobin A1c and hypoglycemia. In: Diabetes Care. 2017 ; Vol. 40, No. 12. pp. 1719-1726.
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abstract = "Objective: Artificial pancreas (AP) systems are best positioned for optimal treatment of type 1 diabetes (T1D) and are currently being tested in outpatient clinical trials. Our consortium developed and tested a novel adaptive AP in an outpatient, single-arm, uncontrolled multicenter clinical trial lasting 12 weeks. Research Design and Methods: Thirty adults with T1D completed a continuous glucose monitor (CGM)-augmented 1-week sensor-augmented pump(SAP) period. After the AP was started, basal insulin delivery settings used by the AP for initialization were adapted weekly, and carbohydrate ratios were adapted every 4 weeks by an algorithm running on a cloud-based server, with automatic data upload from devices. Adaptations were reviewed by expert study clinicians and patients. The primary end point was change in hemoglobin A1c (HbA1c). Outcomes are reported adhering to consensus recommendations on reporting of AP trials. Results: Twenty-nine patients completed the trial. HbA1c, 7.0 ± 0.8{\%} at the start of AP use, improved to 6.7 ± 0.6{\%} after 12 weeks (-0.3, 95{\%} CI -0.5 to -0.2, P < 0.001). Compared with the SAP run-in, CGM time spent in the hypoglycemic range improved during the day from 5.0 to 1.9{\%}(-3.1, 95{\%} CI -4.1 to -2.1, P < 0.001) and overnight from 4.1 to 1.1{\%} (-3.1, 95{\%} CI -4.2 to -1.9, P < 0.001). Whereas carbohydrate ratios were adapted to a larger extent initially with minimal changes there after, basal insulin was adapted throughout. Approximately 10{\%} of adaptation recommendations were manually overridden. There were no protocol-related serious adverse events. Conclusions: Use of our novel adaptive AP yielded significant reductions in HbA1c and hypoglycemia.",
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T1 - Twelve-week 24/7 ambulatory artificial pancreas with weekly adaptation of insulin delivery settings

T2 - Effect on hemoglobin A1c and hypoglycemia

AU - Dassau, Eyal

AU - Pinsker, Jordan E.

AU - Kudva, Yogish C

AU - Brown, Sue A.

AU - Gondhalekar, Ravi

AU - Man, Chiara Dalla

AU - Patek, Steve

AU - Schiavon, Michele

AU - Dadlani, Vikash

AU - Dasanayake, Isuru

AU - Church, Mei Mei

AU - Carter, Rickey E.

AU - Bevier, Wendy C.

AU - Huyett, Lauren M.

AU - Hughes, Jonathan

AU - Anderson, Stacey

AU - Lv, Dayu

AU - Schertz, Elaine

AU - Emory, Emma

AU - McCrady-Spitzer, Shelly K.

AU - Jean, Tyler

AU - Bradley, Paige K.

AU - Hinshaw, Ling

AU - Laguna Sanz, Alejandro J.

AU - Basu, Ananda

AU - Kovatchev, Boris

AU - Cobelli, Claudio

AU - Doyle, Francis J.

PY - 2017/12/1

Y1 - 2017/12/1

N2 - Objective: Artificial pancreas (AP) systems are best positioned for optimal treatment of type 1 diabetes (T1D) and are currently being tested in outpatient clinical trials. Our consortium developed and tested a novel adaptive AP in an outpatient, single-arm, uncontrolled multicenter clinical trial lasting 12 weeks. Research Design and Methods: Thirty adults with T1D completed a continuous glucose monitor (CGM)-augmented 1-week sensor-augmented pump(SAP) period. After the AP was started, basal insulin delivery settings used by the AP for initialization were adapted weekly, and carbohydrate ratios were adapted every 4 weeks by an algorithm running on a cloud-based server, with automatic data upload from devices. Adaptations were reviewed by expert study clinicians and patients. The primary end point was change in hemoglobin A1c (HbA1c). Outcomes are reported adhering to consensus recommendations on reporting of AP trials. Results: Twenty-nine patients completed the trial. HbA1c, 7.0 ± 0.8% at the start of AP use, improved to 6.7 ± 0.6% after 12 weeks (-0.3, 95% CI -0.5 to -0.2, P < 0.001). Compared with the SAP run-in, CGM time spent in the hypoglycemic range improved during the day from 5.0 to 1.9%(-3.1, 95% CI -4.1 to -2.1, P < 0.001) and overnight from 4.1 to 1.1% (-3.1, 95% CI -4.2 to -1.9, P < 0.001). Whereas carbohydrate ratios were adapted to a larger extent initially with minimal changes there after, basal insulin was adapted throughout. Approximately 10% of adaptation recommendations were manually overridden. There were no protocol-related serious adverse events. Conclusions: Use of our novel adaptive AP yielded significant reductions in HbA1c and hypoglycemia.

AB - Objective: Artificial pancreas (AP) systems are best positioned for optimal treatment of type 1 diabetes (T1D) and are currently being tested in outpatient clinical trials. Our consortium developed and tested a novel adaptive AP in an outpatient, single-arm, uncontrolled multicenter clinical trial lasting 12 weeks. Research Design and Methods: Thirty adults with T1D completed a continuous glucose monitor (CGM)-augmented 1-week sensor-augmented pump(SAP) period. After the AP was started, basal insulin delivery settings used by the AP for initialization were adapted weekly, and carbohydrate ratios were adapted every 4 weeks by an algorithm running on a cloud-based server, with automatic data upload from devices. Adaptations were reviewed by expert study clinicians and patients. The primary end point was change in hemoglobin A1c (HbA1c). Outcomes are reported adhering to consensus recommendations on reporting of AP trials. Results: Twenty-nine patients completed the trial. HbA1c, 7.0 ± 0.8% at the start of AP use, improved to 6.7 ± 0.6% after 12 weeks (-0.3, 95% CI -0.5 to -0.2, P < 0.001). Compared with the SAP run-in, CGM time spent in the hypoglycemic range improved during the day from 5.0 to 1.9%(-3.1, 95% CI -4.1 to -2.1, P < 0.001) and overnight from 4.1 to 1.1% (-3.1, 95% CI -4.2 to -1.9, P < 0.001). Whereas carbohydrate ratios were adapted to a larger extent initially with minimal changes there after, basal insulin was adapted throughout. Approximately 10% of adaptation recommendations were manually overridden. There were no protocol-related serious adverse events. Conclusions: Use of our novel adaptive AP yielded significant reductions in HbA1c and hypoglycemia.

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