Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Feb;16(2):527-34.
doi: 10.1111/ajt.13539. Epub 2015 Nov 20.

Successful Application of Closed-Loop Artificial Pancreas Therapy After Islet Autotransplantation

G P Forlenza  1   2 , B M Nathan  1 , A M Moran  1 , T B Dunn  3 , G J Beilman  3 , T L Pruett  3 , M D Bellin  1
Affiliations
Randomized Controlled Trial

Successful Application of Closed-Loop Artificial Pancreas Therapy After Islet Autotransplantation

G P Forlenza et al. Am J Transplant. 2016 Feb.

Abstract

Total pancreatectomy with islet autotransplantation (TPIAT) may relieve the pain of chronic pancreatitis while avoiding postsurgical diabetes. Minimizing hyperglycemia after TPIAT limits beta cell apoptosis during islet engraftment. Closed-loop (CL) therapy combining an insulin pump with a continuous glucose monitor (CGM) has not been investigated previously in islet transplant recipients. Our objective was to determine the feasibility and efficacy of CL therapy to maintain glucose profiles close to normoglycemia following TPIAT. Fourteen adult subjects (36% male; aged 35.9 ± 11.4 years) were randomized to subcutaneous insulin via CL pump (n = 7) or multiple daily injections with blinded CGM (n = 7) for 72 h at transition from intravenous to subcutaneous insulin. Mean serum glucose values were significantly lower in the CL pump group than in the control group (111 ± 4 vs. 130 ± 13 mg/dL; p = 0.003) without increased risk of hypoglycemia (percentage of time <70 mg/dL: CL pump 1.9%, control 4.8%; p = 0.46). Results from this pilot study suggest that CL therapy is superior to conventional therapy in maintaining euglycemia without increased hypoglycemia. This technology shows significant promise to safely maintain euglycemic targets during the period of islet engraftment following islet transplantation.

Trial registration: ClinicalTrials.gov NCT01945138.

Keywords: artificial organs; autotransplantation; clinical research; diabetology; endocrinology; islet transplantation; islets of Langerhans; practice; support devices; type 1.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Recruitment Flow Chart
Figure 2
Figure 2
Serum Glucose Values by Patient and Study Group. Large circle denotes mean, box denotes 25th percentile, median and 75th percentile and small circles denote outliers.
Figure 3
Figure 3
Multiple Least-Squares Linear Regression Analysis for Effect Modification
See this image and copyright information in PMC

References

    1. Hathout E, Chan NK, Tan A, Sakata N, Mace J, Pearce W, et al. In vivo imaging demonstrates a time-line for new vessel formation in islet transplantation. Pediatric transplantation. 2009;13(7):892–7. - PMC - PubMed
    1. Speier S, Nyqvist D, Cabrera O, Yu J, Molano RD, Pileggi A, et al. Noninvasive in vivo imaging of pancreatic islet cell biology. Nature medicine. 2008;14(5):574–8. - PMC - PubMed
    1. Finzi G, Davalli A, Placidi C, Usellini L, La Rosa S, Folli F, et al. Morphological and ultrastructural features of human islet grafts performed in diabetic nude mice. Ultrastructural pathology. 2005;29(6):525–33. - PubMed
    1. Nacher V, Merino JF, Raurell M, Soler J, Montanya E. Normoglycemia restores beta-cell replicative response to glucose in transplanted islets exposed to chronic hyperglycemia. Diabetes. 1998;47(2):192–6. - PubMed
    1. Biarnes M, Montolio M, Nacher V, Raurell M, Soler J, Montanya E. Beta-cell death and mass in syngeneically transplanted islets exposed to short- and long-term hyperglycemia. Diabetes. 2002;51(1):66–72. - PubMed

Publication types

MeSH terms

Associated data