Glucose sensor-augmented continuous subcutaneous insulin infusion in patients with diabetic gastroparesis: An open-label pilot prospective study

Jorge Calles-Escandón, Kenneth L. Koch, William L. Hasler, Mark L. Van Natta, Pankaj J. Pasricha, James Tonascia, Henry P. Parkman, Frank Hamilton, William H. Herman, Marina Basina, Bruce Buckingham, Karen Earle, Kjersti Kirkeby, Kristen Hairston, Tamis Bright, Amy E. Rothberg, Andrew T. Kraftson, Elias S. Siraj, Angela Subauste, Linda A. LeeThomas L. Abell, Richard W. McCallum, Irene Sarosiek, Linda Nguyen, Ronnie Fass, William J. Snape, Ivana A. Vaughn, Laura A. Miriel, Gianrico Farrugia

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Erratic blood glucose levels can be a cause and consequence of delayed gastric emptying in patients with diabetes. It is unknown if better glycemic control increases risks of hypoglycemia or improves hemoglobin A1c levels and gastrointestinal symptoms in diabetic gastroparesis. This study investigated the safety and potential efficacy of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) in poorly controlled diabetes with gastroparesis. Forty-five type 1 or 2 patients with diabetes and gastroparesis and hemoglobin A1c >8% from the NIDDK Gastroparesis Consortium enrolled in a 24 week open-label pilot prospective study of CSII plus CGM. The primary safety outcome was combined numbers of mild, moderate, and severe hypoglycemic events at screening and 24 weeks treatment. Secondary outcomes included glycemic excursions on CGM, hemoglobin A1c, gastroparesis symptoms, quality-of-life, and liquid meal tolerance. Combined mild, moderate, and severe hypoglycemic events occurred similarly during the screening/run-in (1.9/week) versus treatment (2.2/week) phases with a relative risk of 1.18 (95% CI 0.85–1.64, P = 0.33). CGM time in hypoglycemia (<70 mg/dL) decreased from 3.9% to 1.8% (P<0.0001), time in euglycemia (70–180 mg/dL) increased from 44.0% to 52.0% (P = 0.02), time in severe hyperglycemia (>300 mg/dL) decreased from 14.2% to 7.0% (P = 0.005), and hemoglobin A1c decreased from 9.4±1.4% to 8.3±1.3% (P = 0.001) on CSII plus CGM. Symptom scores decreased from 29.3±7.1 to 21.9±10.2 with lower nausea/vomiting, fullness/early satiety, and bloating/distention scores (P0.001). Quality-of-life scores improved from 2.4±1.1 to 3.1±1.1 (P<0.0001) and volumes of liquid nutrient meals tolerated increased from 420±258 to 487±312 mL (P = 0.05) at 24 weeks. In conclusion, CSII plus CGM appeared to be safe with minimal risks of hypoglycemic events and associated improvements in glycemic control, gastroparesis symptoms, quality-of-life, and meal tolerance in patients with poorly controlled diabetes and gastroparesis. This study supports the safety, feasibility, and potential benefits of improving glycemic control in diabetic gastroparesis.

Original languageEnglish (US)
Article numbere0194759
JournalPLoS One
Volume13
Issue number4
DOIs
StatePublished - Apr 1 2018

Fingerprint

Gastroparesis
Glucose sensors
Subcutaneous Infusions
prospective studies
Labels
glycohemoglobin
insulin
Prospective Studies
Insulin
Medical problems
Glucose
glycemic control
glucose
signs and symptoms (animals and humans)
diabetes
Monitoring
monitoring
Hemoglobins
quality of life
Hypoglycemic Agents

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)

Cite this

Glucose sensor-augmented continuous subcutaneous insulin infusion in patients with diabetic gastroparesis : An open-label pilot prospective study. / Calles-Escandón, Jorge; Koch, Kenneth L.; Hasler, William L.; Van Natta, Mark L.; Pasricha, Pankaj J.; Tonascia, James; Parkman, Henry P.; Hamilton, Frank; Herman, William H.; Basina, Marina; Buckingham, Bruce; Earle, Karen; Kirkeby, Kjersti; Hairston, Kristen; Bright, Tamis; Rothberg, Amy E.; Kraftson, Andrew T.; Siraj, Elias S.; Subauste, Angela; Lee, Linda A.; Abell, Thomas L.; McCallum, Richard W.; Sarosiek, Irene; Nguyen, Linda; Fass, Ronnie; Snape, William J.; Vaughn, Ivana A.; Miriel, Laura A.; Farrugia, Gianrico.

In: PLoS One, Vol. 13, No. 4, e0194759, 01.04.2018.

Research output: Contribution to journalArticle

Calles-Escandón, J, Koch, KL, Hasler, WL, Van Natta, ML, Pasricha, PJ, Tonascia, J, Parkman, HP, Hamilton, F, Herman, WH, Basina, M, Buckingham, B, Earle, K, Kirkeby, K, Hairston, K, Bright, T, Rothberg, AE, Kraftson, AT, Siraj, ES, Subauste, A, Lee, LA, Abell, TL, McCallum, RW, Sarosiek, I, Nguyen, L, Fass, R, Snape, WJ, Vaughn, IA, Miriel, LA & Farrugia, G 2018, 'Glucose sensor-augmented continuous subcutaneous insulin infusion in patients with diabetic gastroparesis: An open-label pilot prospective study', PLoS One, vol. 13, no. 4, e0194759. https://doi.org/10.1371/journal.pone.0194759
Calles-Escandón, Jorge ; Koch, Kenneth L. ; Hasler, William L. ; Van Natta, Mark L. ; Pasricha, Pankaj J. ; Tonascia, James ; Parkman, Henry P. ; Hamilton, Frank ; Herman, William H. ; Basina, Marina ; Buckingham, Bruce ; Earle, Karen ; Kirkeby, Kjersti ; Hairston, Kristen ; Bright, Tamis ; Rothberg, Amy E. ; Kraftson, Andrew T. ; Siraj, Elias S. ; Subauste, Angela ; Lee, Linda A. ; Abell, Thomas L. ; McCallum, Richard W. ; Sarosiek, Irene ; Nguyen, Linda ; Fass, Ronnie ; Snape, William J. ; Vaughn, Ivana A. ; Miriel, Laura A. ; Farrugia, Gianrico. / Glucose sensor-augmented continuous subcutaneous insulin infusion in patients with diabetic gastroparesis : An open-label pilot prospective study. In: PLoS One. 2018 ; Vol. 13, No. 4.
@article{83783e0180e44c76b2ca6f4f59fcea73,
title = "Glucose sensor-augmented continuous subcutaneous insulin infusion in patients with diabetic gastroparesis: An open-label pilot prospective study",
abstract = "Erratic blood glucose levels can be a cause and consequence of delayed gastric emptying in patients with diabetes. It is unknown if better glycemic control increases risks of hypoglycemia or improves hemoglobin A1c levels and gastrointestinal symptoms in diabetic gastroparesis. This study investigated the safety and potential efficacy of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) in poorly controlled diabetes with gastroparesis. Forty-five type 1 or 2 patients with diabetes and gastroparesis and hemoglobin A1c >8{\%} from the NIDDK Gastroparesis Consortium enrolled in a 24 week open-label pilot prospective study of CSII plus CGM. The primary safety outcome was combined numbers of mild, moderate, and severe hypoglycemic events at screening and 24 weeks treatment. Secondary outcomes included glycemic excursions on CGM, hemoglobin A1c, gastroparesis symptoms, quality-of-life, and liquid meal tolerance. Combined mild, moderate, and severe hypoglycemic events occurred similarly during the screening/run-in (1.9/week) versus treatment (2.2/week) phases with a relative risk of 1.18 (95{\%} CI 0.85–1.64, P = 0.33). CGM time in hypoglycemia (<70 mg/dL) decreased from 3.9{\%} to 1.8{\%} (P<0.0001), time in euglycemia (70–180 mg/dL) increased from 44.0{\%} to 52.0{\%} (P = 0.02), time in severe hyperglycemia (>300 mg/dL) decreased from 14.2{\%} to 7.0{\%} (P = 0.005), and hemoglobin A1c decreased from 9.4±1.4{\%} to 8.3±1.3{\%} (P = 0.001) on CSII plus CGM. Symptom scores decreased from 29.3±7.1 to 21.9±10.2 with lower nausea/vomiting, fullness/early satiety, and bloating/distention scores (P0.001). Quality-of-life scores improved from 2.4±1.1 to 3.1±1.1 (P<0.0001) and volumes of liquid nutrient meals tolerated increased from 420±258 to 487±312 mL (P = 0.05) at 24 weeks. In conclusion, CSII plus CGM appeared to be safe with minimal risks of hypoglycemic events and associated improvements in glycemic control, gastroparesis symptoms, quality-of-life, and meal tolerance in patients with poorly controlled diabetes and gastroparesis. This study supports the safety, feasibility, and potential benefits of improving glycemic control in diabetic gastroparesis.",
author = "Jorge Calles-Escand{\'o}n and Koch, {Kenneth L.} and Hasler, {William L.} and {Van Natta}, {Mark L.} and Pasricha, {Pankaj J.} and James Tonascia and Parkman, {Henry P.} and Frank Hamilton and Herman, {William H.} and Marina Basina and Bruce Buckingham and Karen Earle and Kjersti Kirkeby and Kristen Hairston and Tamis Bright and Rothberg, {Amy E.} and Kraftson, {Andrew T.} and Siraj, {Elias S.} and Angela Subauste and Lee, {Linda A.} and Abell, {Thomas L.} and McCallum, {Richard W.} and Irene Sarosiek and Linda Nguyen and Ronnie Fass and Snape, {William J.} and Vaughn, {Ivana A.} and Miriel, {Laura A.} and Gianrico Farrugia",
year = "2018",
month = "4",
day = "1",
doi = "10.1371/journal.pone.0194759",
language = "English (US)",
volume = "13",
journal = "PLoS One",
issn = "1932-6203",
publisher = "Public Library of Science",
number = "4",

}

TY - JOUR

T1 - Glucose sensor-augmented continuous subcutaneous insulin infusion in patients with diabetic gastroparesis

T2 - An open-label pilot prospective study

AU - Calles-Escandón, Jorge

AU - Koch, Kenneth L.

AU - Hasler, William L.

AU - Van Natta, Mark L.

AU - Pasricha, Pankaj J.

AU - Tonascia, James

AU - Parkman, Henry P.

AU - Hamilton, Frank

AU - Herman, William H.

AU - Basina, Marina

AU - Buckingham, Bruce

AU - Earle, Karen

AU - Kirkeby, Kjersti

AU - Hairston, Kristen

AU - Bright, Tamis

AU - Rothberg, Amy E.

AU - Kraftson, Andrew T.

AU - Siraj, Elias S.

AU - Subauste, Angela

AU - Lee, Linda A.

AU - Abell, Thomas L.

AU - McCallum, Richard W.

AU - Sarosiek, Irene

AU - Nguyen, Linda

AU - Fass, Ronnie

AU - Snape, William J.

AU - Vaughn, Ivana A.

AU - Miriel, Laura A.

AU - Farrugia, Gianrico

PY - 2018/4/1

Y1 - 2018/4/1

N2 - Erratic blood glucose levels can be a cause and consequence of delayed gastric emptying in patients with diabetes. It is unknown if better glycemic control increases risks of hypoglycemia or improves hemoglobin A1c levels and gastrointestinal symptoms in diabetic gastroparesis. This study investigated the safety and potential efficacy of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) in poorly controlled diabetes with gastroparesis. Forty-five type 1 or 2 patients with diabetes and gastroparesis and hemoglobin A1c >8% from the NIDDK Gastroparesis Consortium enrolled in a 24 week open-label pilot prospective study of CSII plus CGM. The primary safety outcome was combined numbers of mild, moderate, and severe hypoglycemic events at screening and 24 weeks treatment. Secondary outcomes included glycemic excursions on CGM, hemoglobin A1c, gastroparesis symptoms, quality-of-life, and liquid meal tolerance. Combined mild, moderate, and severe hypoglycemic events occurred similarly during the screening/run-in (1.9/week) versus treatment (2.2/week) phases with a relative risk of 1.18 (95% CI 0.85–1.64, P = 0.33). CGM time in hypoglycemia (<70 mg/dL) decreased from 3.9% to 1.8% (P<0.0001), time in euglycemia (70–180 mg/dL) increased from 44.0% to 52.0% (P = 0.02), time in severe hyperglycemia (>300 mg/dL) decreased from 14.2% to 7.0% (P = 0.005), and hemoglobin A1c decreased from 9.4±1.4% to 8.3±1.3% (P = 0.001) on CSII plus CGM. Symptom scores decreased from 29.3±7.1 to 21.9±10.2 with lower nausea/vomiting, fullness/early satiety, and bloating/distention scores (P0.001). Quality-of-life scores improved from 2.4±1.1 to 3.1±1.1 (P<0.0001) and volumes of liquid nutrient meals tolerated increased from 420±258 to 487±312 mL (P = 0.05) at 24 weeks. In conclusion, CSII plus CGM appeared to be safe with minimal risks of hypoglycemic events and associated improvements in glycemic control, gastroparesis symptoms, quality-of-life, and meal tolerance in patients with poorly controlled diabetes and gastroparesis. This study supports the safety, feasibility, and potential benefits of improving glycemic control in diabetic gastroparesis.

AB - Erratic blood glucose levels can be a cause and consequence of delayed gastric emptying in patients with diabetes. It is unknown if better glycemic control increases risks of hypoglycemia or improves hemoglobin A1c levels and gastrointestinal symptoms in diabetic gastroparesis. This study investigated the safety and potential efficacy of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) in poorly controlled diabetes with gastroparesis. Forty-five type 1 or 2 patients with diabetes and gastroparesis and hemoglobin A1c >8% from the NIDDK Gastroparesis Consortium enrolled in a 24 week open-label pilot prospective study of CSII plus CGM. The primary safety outcome was combined numbers of mild, moderate, and severe hypoglycemic events at screening and 24 weeks treatment. Secondary outcomes included glycemic excursions on CGM, hemoglobin A1c, gastroparesis symptoms, quality-of-life, and liquid meal tolerance. Combined mild, moderate, and severe hypoglycemic events occurred similarly during the screening/run-in (1.9/week) versus treatment (2.2/week) phases with a relative risk of 1.18 (95% CI 0.85–1.64, P = 0.33). CGM time in hypoglycemia (<70 mg/dL) decreased from 3.9% to 1.8% (P<0.0001), time in euglycemia (70–180 mg/dL) increased from 44.0% to 52.0% (P = 0.02), time in severe hyperglycemia (>300 mg/dL) decreased from 14.2% to 7.0% (P = 0.005), and hemoglobin A1c decreased from 9.4±1.4% to 8.3±1.3% (P = 0.001) on CSII plus CGM. Symptom scores decreased from 29.3±7.1 to 21.9±10.2 with lower nausea/vomiting, fullness/early satiety, and bloating/distention scores (P0.001). Quality-of-life scores improved from 2.4±1.1 to 3.1±1.1 (P<0.0001) and volumes of liquid nutrient meals tolerated increased from 420±258 to 487±312 mL (P = 0.05) at 24 weeks. In conclusion, CSII plus CGM appeared to be safe with minimal risks of hypoglycemic events and associated improvements in glycemic control, gastroparesis symptoms, quality-of-life, and meal tolerance in patients with poorly controlled diabetes and gastroparesis. This study supports the safety, feasibility, and potential benefits of improving glycemic control in diabetic gastroparesis.

UR - http://www.scopus.com/inward/record.url?scp=85045553471&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85045553471&partnerID=8YFLogxK

U2 - 10.1371/journal.pone.0194759

DO - 10.1371/journal.pone.0194759

M3 - Article

C2 - 29652893

AN - SCOPUS:85045553471

VL - 13

JO - PLoS One

JF - PLoS One

SN - 1932-6203

IS - 4

M1 - e0194759

ER -