1. Glucose sensor-augmented continuous subcutaneous insulin infusion in patients with diabetic gastroparesis: An open-label pilot prospective study
- Author
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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 Lee, Thomas L Abell, Richard W McCallum, Irene Sarosiek, Linda Nguyen, Ronnie Fass, William J Snape, Ivana A Vaughn, Laura A Miriel, Gianrico Farrugia, and NIDDK Gastroparesis Clinical Research Consortium (GpCRC)
- Subjects
Blood Glucose ,Male ,Gastroparesis ,medicine.medical_treatment ,lcsh:Medicine ,Pilot Projects ,Infusions, Subcutaneous ,Gastroenterology ,Biochemistry ,0302 clinical medicine ,Endocrinology ,Medicine and Health Sciences ,Diabetes diagnosis and management ,Insulin ,030212 general & internal medicine ,Prospective cohort study ,lcsh:Science ,Multidisciplinary ,Organic Compounds ,Monosaccharides ,Drugs ,Middle Aged ,3. Good health ,Chemistry ,Treatment Outcome ,Physical Sciences ,Female ,medicine.symptom ,Symptom Assessment ,Research Article ,Adult ,medicine.medical_specialty ,HbA1c ,Adolescent ,Nausea ,Endocrine Disorders ,Carbohydrates ,Hypoglycemics ,030209 endocrinology & metabolism ,Hypoglycemia ,Diabetes Complications ,03 medical and health sciences ,Young Adult ,Diabetes mellitus ,Internal medicine ,medicine ,Diabetes Mellitus ,Humans ,Hemoglobin ,Glycemic ,Aged ,Diabetic Endocrinology ,Pharmacology ,Gastric emptying ,business.industry ,lcsh:R ,Organic Chemistry ,Chemical Compounds ,Biology and Life Sciences ,Proteins ,medicine.disease ,Hormones ,Diagnostic medicine ,Health Care ,Glucose ,Metabolic Disorders ,Hyperglycemia ,Quality of Life ,lcsh:Q ,business - 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 (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
- Published
- 2018