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

被引：29

作者：

Calles-Escandon, Jorge ^{[1
]}

Koch, Kenneth L. ^{[2
]}

Hasler, William L. ^{[3
]}

Van Natta, Mark L. ^{[4
,5
]}

Pasricha, Pankaj J. ^{[6
]}

Tonascia, James ^{[5
]}

Parkman, Henry P. ^{[7
]}

Hamilton, Frank ^{[8
]}

Herman, William H. ^{[9
]}

Basina, Marina ^{[10
]}

Buckingham, Bruce ^{[10
]}

Earle, Karen ^{[11
]}

Kirkeby, Kjersti ^{[11
]}

Hairston, Kristen ^{[12
]}

Bright, Tamis ^{[13
]}

Rothberg, Amy E. ^{[9
]}

Kraftson, Andrew T. ^{[9
]}

Siraj, Elias S. ^{[14
]}

Subauste, Angela ^{[15
]}

Lee, Linda A. ^{[6
]}

Abell, Thomas L. ^{[16
]}

McCallum, Richard W. ^{[17
]}

Sarosiek, Irene ^{[17
]}

Nguyen, Linda ^{[18
]}

Fass, Ronnie ^{[19
]}

Snape, William J. ^{[20
]}

Vaughn, Ivana A. ^{[4
,5
]}

Miriel, Laura A. ^{[4
,5
]}

Farrugia, Gianrico ^{[21
]}

机构：

[1] Case Western Reserve Univ, Endocrinol Sect, MetroHlth Reg, Cleveland, OH 44106 USA

[2] Wake Forest Univ, Sect Gastroenterol, Winston Salem, NC 27109 USA

[3] Univ Michigan, Div Gastroenterol, Ann Arbor, MI 48109 USA

[4] Johns Hopkins Univ, Bloomberg Sch Publ Hlth, Dept Biostat, Baltimore, MD USA

[5] Johns Hopkins Univ, Bloomberg Sch Publ Hlth, Dept Epidemiol, Baltimore, MD USA

[6] Johns Hopkins Sch Med, Sect Gastroenterol, Baltimore, MD USA

[7] Temple Univ, Sch Med, Sect Gastroenterol, Philadelphia, PA USA

[8] Natl Inst Diabet & Digest & Kidney Dis, Bethesda, MD USA

[9] Univ Michigan, Div Metab Endocrinol & Diabet, Ann Arbor, MI 48109 USA

[10] Stanford Univ, Sch Med, Div Pediat Endocrinol, Palo Alto, CA 94304 USA

[11] Calif Pacific Med Ctr, Div Endocrinol, San Francisco, CA USA

[12] Wake Forest Univ, Sect Endocrinol, Winston Salem, NC 27109 USA

[13] Texas Tech Univ, Sch Med, Div Endocrinol Diabet & Metab, El Paso, TX USA

[14] Temple Univ, Sch Med, Sect Endocrinol, Philadelphia, PA USA

[15] Univ Mississippi, Div Endocrinol, Jackson, MS 39216 USA

[16] Univ Louisville, Sch Med, Div Gastroenterol, Louisville, KY 40292 USA

[17] Texas Tech Univ, Sch Med, Sect Gastroenterol, El Paso, TX USA

[18] Stanford Univ, Sch Med, Div Gastroenterol, Palo Alto, CA 94304 USA

[19] Case Western Reserve Univ, Gastroenterol Div, MetroHlth Reg, Cleveland, OH 44106 USA

[20] Calif Pacific Med Ctr, Div Gastroenterol, San Francisco, CA USA

[21] Mayo Clin, Sect Gastroenterol, Rochester, MN USA

来源：

PLOS ONE | 2018年 / 13卷 / 04期

关键词：

COMPLICATIONS TRIAL/EPIDEMIOLOGY; GLYCEMIC CONTROL; HYPERGLYCEMIA; SYMPTOMS; INTERVENTIONS; VALIDATION; SEVERITY; MELLITUS; MEAL;

D O I：

10.1371/journal.pone.0194759

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

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 (P <= 0.001). 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.

引用

页数：19

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