title: Outpatient glycemic control with a bionic pancreas in type 1 diabetes.
abstract: BACKGROUND
  The safety and effectiveness of automated glycemic management have not been tested in multiday studies under unrestricted outpatient conditions.
  
  
  METHODS
  In two random-order, crossover studies with similar but distinct designs, we compared glycemic control with a wearable, bihormonal, automated, "bionic" pancreas (bionic-pancreas period) with glycemic control with an insulin pump (control period) for 5 days in 20 adults and 32 adolescents with type 1 diabetes mellitus. The automatically adaptive algorithm of the bionic pancreas received data from a continuous glucose monitor to control subcutaneous delivery of insulin and glucagon.
  
  
  RESULTS
  Among the adults, the mean plasma glucose level over the 5-day bionic-pancreas period was 138 mg per deciliter (7.7 mmol per liter), and the mean percentage of time with a low glucose level (<70 mg per deciliter [3.9 mmol per liter]) was 4.8%. After 1 day of automatic adaptation by the bionic pancreas, the mean (±SD) glucose level on continuous monitoring was lower than the mean level during the control period (133±13 vs. 159±30 mg per deciliter [7.4±0.7 vs. 8.8±1.7 mmol per liter], P<0.001) and the percentage of time with a low glucose reading was lower (4.1% vs. 7.3%, P=0.01). Among the adolescents, the mean plasma glucose level was also lower during the bionic-pancreas period than during the control period (138±18 vs. 157±27 mg per deciliter [7.7±1.0 vs. 8.7±1.5 mmol per liter], P=0.004), but the percentage of time with a low plasma glucose reading was similar during the two periods (6.1% and 7.6%, respectively; P=0.23). The mean frequency of interventions for hypoglycemia among the adolescents was lower during the bionic-pancreas period than during the control period (one per 1.6 days vs. one per 0.8 days, P<0.001).
  
  
  CONCLUSIONS
  As compared with an insulin pump, a wearable, automated, bihormonal, bionic pancreas improved mean glycemic levels, with less frequent hypoglycemic episodes, among both adults and adolescents with type 1 diabetes mellitus. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov numbers, NCT01762059 and NCT01833988.).
authors.affiliation: Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Russell
authors.affiliation: Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
authors.forename: Firas H
authors.initials: FH
authors.lastname: El-Khatib
authors.affiliation: Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
authors.forename: Manasi
authors.initials: M
authors.lastname: Sinha
authors.affiliation: Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
authors.forename: Kendra L
authors.initials: KL
authors.lastname: Magyar
authors.affiliation: Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
authors.forename: Katherine
authors.initials: K
authors.lastname: McKeon
authors.affiliation: Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
authors.forename: Laura G
authors.initials: LG
authors.lastname: Goergen
authors.affiliation: Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
authors.forename: Courtney
authors.initials: C
authors.lastname: Balliro
authors.affiliation: Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
authors.forename: Mallory A
authors.initials: MA
authors.lastname: Hillard
authors.affiliation: Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
authors.forename: David M
authors.initials: DM
authors.lastname: Nathan
authors.affiliation: Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
authors.forename: Edward R
authors.initials: ER
authors.lastname: Damiano
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001701:Bionics; D001786:Blood Glucose / Q000378:metabolism; D002648:Child; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy / Q000628:therapy*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000209:etiology; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D019397:Pancreas, Artificial / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin