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1. Improved postprandial glucose control with ultra rapid lispro versus lispro with continuous subcutaneous insulin infusion in type 1 diabetes: <scp>PRONTO‐Pump</scp> ‐2

Author

Moshe Phillip, Rong Liu, Debra A. Ignaut, Mark Warren, Barry Horowitz, Farai Chigutsa, Janet Tobian, Jang Ik Cho, Thomas Hardy, and Bruce W. Bode

Subjects
Blood Glucose, medicine.medical_specialty, Diabetic ketoacidosis, type 1 diabetes, insulin analogues, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Internal medicine, Internal Medicine, Clinical endpoint, medicine, Humans, Hypoglycemic Agents, Insulin, Adverse effect, Glycated Hemoglobin, Type 1 diabetes, Insulin Lispro, continuous subcutaneous insulin infusion, business.industry, Incidence (epidemiology), Original Articles, medicine.disease, Confidence interval, Subcutaneous insulin, Diabetes Mellitus, Type 1, Postprandial, Original Article, continuous glucose monitoring, business
Abstract

Aim To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro (Humalog®) in people with type 1 diabetes on continuous subcutaneous insulin infusion (CSII). Materials and Methods This was a phase 3, 16‐week, treat‐to‐target study in patients randomized to double‐blind URLi (N = 215) or lispro (N = 217). The primary endpoint was change from baseline HbA1c (non‐inferiority margin 4.4 mmol/mol [0.4%]), with multiplicity‐adjusted objectives for postprandial glucose (PPG) levels during a meal test, and time spent in the target range 70–180 mg/dL (TIR). Results URLi was non‐inferior to lispro for change in HbA1c, with a least‐squares mean (LSM) difference of 0.3 mmol/mol (95% confidence interval [CI] –0.6, 1.2) or 0.02% (95% CI –0.06, 0.11). URLi was superior to lispro in controlling 1‐ and 2‐h PPG levels after the meal test: LSM difference −1.34 mmol/L (95% CI –2.00, −0.68) or −24.1 mg/dL (95% CI –36.0, −12.2) at 1 h and −1.54 mmol/L (95% CI –2.37, −0.72) or −27.8 mg/dL (95% CI –42.6, −13.0) at 2 h; both p

Published
2021

2. Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26‐week <scp>PRONTO‐T1D</scp> study

Author

Juliana M. Bue-Valleskey, Dachuang Cao, Dominik Dahl, Junnosuke Miura, Janet Tobian, Jean Lucas, Mary Anne Dellva, and Leslie J. Klaff

Subjects
Adult, Blood Glucose, medicine.medical_specialty, endocrine system diseases, Endocrinology, Diabetes and Metabolism, Insulin Glargine, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, Gastroenterology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Randomized controlled trial, law, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, Clinical endpoint, Humans, Hypoglycemic Agents, Insulin lispro, Glycated Hemoglobin, Type 1 diabetes, Insulin Lispro, business.industry, Insulin glargine, digestive, oral, and skin physiology, Original Articles, Postprandial Period, medicine.disease, Confidence interval, Diabetes Mellitus, Type 1, Postprandial, Original Article, business, medicine.drug
Abstract

Aims To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes in a 26‐week, treat‐to‐target, phase 3 trial. Materials and methods After an 8‐week lead‐in to optimize basal insulin glargine or degludec, patients were randomized to double‐blind mealtime URLi (n = 451) or lispro (n = 442), or open‐label post‐meal URLi (n = 329). The primary endpoint was change from baseline glycated haemoglobin (HbA1c) to 26 weeks (non‐inferiority margin 0.4%), with multiplicity‐adjusted objectives for postprandial glucose (PPG) excursions after a meal test. Results Both mealtime and post‐meal URLi demonstrated non‐inferiority to lispro for HbA1c: estimated treatment difference (ETD) for mealtime URLi −0.08% [95% confidence interval (CI) −0.16, 0.00] and for post‐meal URLi +0.13% (95% CI 0.04, 0.22), with a significantly higher endpoint HbA1c for post‐meal URLi versus lispro (P = 0.003). Mealtime URLi was superior to lispro in reducing 1‐ and 2‐hour PPG excursions during the meal test: ETD −1.55 mmol/L (95% CI −1.96, −1.14) at 1 hour and − 1.73 mmol/L (95% CI −2.28, −1.18) at 2 hours (both P 4 hours after meals (P = 0.013). Injection site reactions were reported by 2.9% of patients on mealtime URLi, 2.4% on post‐meal URLi, and 0.2% on lispro. Overall, the incidence of treatment‐emergent adverse events was similar between treatments. Conclusions The results showed that URLi provided good glycaemic control, with non‐inferiority to lispro confirmed for both mealtime and post‐meal URLi, while superior PPG control was demonstrated with mealtime dosing.

Published
2020

3. Circulating sex hormone binding globulin levels are modified with intensive lifestyle intervention, but their changes did not independently predict diabetes risk in the Diabetes Prevention Program

Author

Mike Reidy, Christine Lee, Michael Brändle, Sherita Hill Golden, Samuel Dagogo-Jack, David Kessler, Elizabeth Barrett-Connor, Steve Jones, Ling Chen, Judith Wylie-Rosett, Ping Zhang, Paula Williamson, Carlos Lorenzo, Leigh Perreault, Dana Dabelea, Santica Marcovina, Rachel Williams, Marie Smith, Carmen Pal, Patricia Katz, William H. Herman, Sharon L Edelstein, Yong Ma, Vanita R Aroda, Costas A Christophi, Catherine Kim, Sherita H Golden, Edward Horton, Kieren J Mather, George A. Bray, Kishore Gadde, Iris W. Culbert, Jennifer Arceneaux, Annie Chatellier, Amber Dragg, Catherine M. Champagne, Crystal Duncan, Barbara Eberhardt, Frank Greenway, Fonda G. Guillory, April A. Herbert, Michael L. Jeffirs, Betty M. Kennedy, Erma Levy, Monica Lockett, Jennifer C. Lovejoy, Laura H. Morris, Lee E. Melancon, Donna H. Ryan, Deborah A. Sanford, Kenneth G. Smith, Lisa L. Smith, Julia A. St, Richard T. Tulley Amant, Paula C. Vicknair, Donald Williamson, Jeffery J. Zachwieja, Kenneth S. Polonsky, Janet Tobian, David A. Ehrmann, Margaret J. Matulik, Bart Clark, Kirsten Czech, Catherine DeSandre, Ruthanne Hilbrich, Wylie McNabb, Ann R. Semenske, Jose F. Caro, Kevin Furlong, Barry J. Goldstein, Pamela G. Watson, Kellie A. Smith, Jewel Mendoza, Wendi Wildman, Renee Liberoni, John Spandorfer, Constance Pepe, Richard P. Donahue, Ronald B. Goldberg, Ronald Prineas, Jeanette Calles, Juliet Ojito, Patricia Rowe, Paul Cassanova-Romero, Sumaya Castillo-Florez, Hermes J. Florez, Anna Giannella, Lascelles Kirby, Carmen Larreal, Olga Lara, Valerie McLymont, Jadell Mendez, Arlette Perry, Patrice Saab, Beth Veciana, Steven M. Haffner, Helen P. Hazuda, Maria G. Montez, Kathy Hattaway, Arlene Martinez, Tatiana Walker, Richard F. Hamman, Patricia V. Nash, Sheila C. Steinke, Lisa Testaverde, Denise R. Anderson, Larry B. Ballonoff, Alexis Bouffard, Brian Bucca, B. Ned Calonge, Lynne Delve, Martha Farago, James O. Hill, Shelley R. Hoyer, Tonya Jenkins, Bonnie T. Jortberg, Dione Lenz, Marsha Miller, David W. Price, Judith G. Regensteiner, Helen Seagle, Carissa M. Smith, Brent VanDorsten, Edward S. Horton, Kathleen E. Lawton, Catherine S. Poirier, Kati Swift, Ronald A. Arky, Marybeth Bryant, Jacqueline P. Burke, Enrique Caballero, Karen M. Callaphan, Barbara Fargnoli, Therese Franklin, Om P. Ganda, Ashley Guidi, Mathew Guido, Sharon D. Jackson, Alan M. Jacobsen, Lori Lambert, Sarah Ledbury, Margaret Kocal, Lyn M. Kula, Maureen A. Malloy, Maryanne Nicosia, Cathryn F. Oldmixon, Jocelyn Pan, Marizel Quitingon, Stacy Rubtchinsky, Jessica Sansoucy, Dana Schweizer, Ellen W. Seely, Donald Simonson, Fannie Smith, Caren G. Solomon, Jeanne Spellman, James Warram, Steven E. Kahn, Brenda K. Montgomery, Wilfred Fujimoto, Robert H. Knopp, Edward W. Lipkin, Michelle Marr, Ivy Morgan-Taggart, Anne Murillo, Dace Trence, Lonnese Taylor, April Thomas, Elaine C. Tsai, Abbas E. Kitabchi, Mary E. Murphy, Laura Taylor, Jennifer Dolgoff, William B. Applegate, Michael Bryer-Ash, Debra Clark, Sandra L. Frieson, Uzoma Ibebuogu, Raed Imseis, Helen Lambeth, Lynne C. Lichtermann, Hooman Oktaei, Harriet Ricks, Lily M.K. Rutledge, Amy R. Sherman, Clara M. Smith, Judith E. Soberman, Beverly Williams-Cleaves, Boyd E. Metzger, Mark E. Molitch, Mariana K. Johnson, Daphne T. Adelman, Catherine Behrends, Michelle Cook, Marian Fitzgibbon, Mimi M. Giles, Deloris Heard, Cheryl K.H. Johnson, Diane Larsen, Anne Lowe, Megan Lyman, David McPherson, Samsam C. Penn, Thomas Pitts, Renee Reinhart, Susan Roston, Pamela A. Schinleber, David M. Nathan, Charles McKitrick, Heather Turgeon, Mary Larkin, Kathy Abbott, Ellen Anderson, Laurie Bissett, Kristy Bondi, Enrico Cagliero, Jose C. Florez, Kali D’Anna, Linda Delahanty, Valerie Goldman, Peter Lou, Alexandra Poulos, Elyse Raymond, Christine Stevens, Beverly Tseng, Jerrold M. Olefsky, Mary Lou Carrion-Petersen, Madeline Beltran, Lauren N. Claravall, Jonalle M. Dowden, Steven V. Edelman, Robert R. Henry, Javiva Horne, Marycie Lamkin, Simona Szerdi Janesch, Diana Leos, Sunder Mudaliar, William Polonsky, Jean Smith, Jennifer Torio-Hurley, Karen Vejvoda, F. Xavier Pi-Sunyer, Jane E. Lee, David B. Allison, Nnenna Agharanya, Nancy J. Aronoff, Maria Baldo, Jill P. Crandall, Sandra T. Foo, Susan Hagamen, Jose A. Luchsinger, Kathy Parkes, Mary Beth Pena, Ellen S. Rooney, Gretchen E.H. Van Wye, Kristine A. Viscovich, David G. Marrero, Kieren J. Mather, Melvin J. Prince, Susie M. Kelly, Marcia A. Jackson, Gina McAtee, Paula Putenney, Ronald T. Ackermann, Carolyn M. Cantrell, Yolanda F. Dotson, Edwin S. Fineberg, Megan Fultz, John C. Guare, Angela Hadden, James M. Ignaut, Marion S. Kirkman, Erin O’Kelly Phillips, Beverly D. Porter, Paris J. Roach, Nancy D. Rowland, Madelyn L. Wheeler, Vanita Aroda, Robert E. Ratner, Gretchen Youssef, Sue Shapiro, Catherine Bavido-Arrage, Geraldine Boggs, Marjorie Bronsord, Ernestine Brown, Wayman W. Cheatham, Susan Cola, Cindy Evans, Peggy Gibbs, Tracy Kellum, Renee Wiggins, Milvia Lagarda, Lilia Leon, Claresa Levatan, Milajurine Lindsay, Asha K. Nair, Maureen Passaro, Angela Silverman, Gabriel Uwaifo, Debra Wells-Thayer, Mohammed F. Saad, Karol Watson, Maria Budget, Sujata Jinagouda, Medhat Botrous, Khan Akbar, Claudia Conzues, Perpetua Magpuri, Kathy Ngo, Amer Rassam, Debra Waters, Kathy Xapthalamous, Julio V. Santiago, Neil H. White, Angela L. Brown, Samia Das, Prajakta Khare-Ranade, Tamara Stich, Ana Santiago, Edwin Fisher, Emma Hurt, Tracy Jones, Michelle Kerr, Lucy Ryder, Cormarie Wernimont, Christopher D. Saudek, Vanessa Bradley, Emily Sullivan, Tracy Whittington, Caroline Abbas, Adrienne Allen, Frederick L. Brancati, Sharon Cappelli, Jeanne M. Clark, Jeanne B. Charleston, Janice Freel, Katherine Horak, Alicia Greene, Dawn Jiggetts, Deloris Johnson, Hope Joseph, Kimberly Loman, Henry Mosley, John Reusing, Richard R. Rubin, Alafia Samuels, Thomas Shields, Shawne Stephens, Kerry J. Stewart, LeeLana Thomas, Evonne Utsey, David S. Schade, Karwyn S. Adams, Janene L. Canady, Carolyn Johannes, Claire Hemphill, Penny Hyde, Leslie F. Atler, Patrick J. Boyle, Mark R. Burge, Lisa Chai, Kathleen Colleran, Ysela Gonzales, Doris A. Hernandez-McGinnis, Carolyn King, Sofya Rubinchik, Willette Senter, Jill Crandall, Harry Shamoon, Janet O. Brown, Gilda Trandafirescu, Elsie Adorno, Liane Cox, Helena Duffy, Samuel Engel, Allison Friedler, Angela Goldstein, Crystal J. Howard-Century, Jennifer Lukin, Stacey Kloiber, Nadege Longchamp, Helen Martinez, Dorothy Pompi, Jonathan Scheindlin, Elissa Violino, Elizabeth A. Walker, Elise Zimmerman, Joel Zonszein, Trevor Orchard, Rena R. Wing, Susan Jeffries, Gaye Koenning, M. Kaye Kramer, Susan Barr, Catherine Benchoff, Miriam Boraz, Lisa Clifford, Rebecca Culyba, Marlene Frazier, Ryan Gilligan, Stephanie Guimond, Susan Harrier, Louann Harris, Andrea Kriska, Bonny Rockette-Wagner, Qurashia Manjoo, Monica Mullen, Alicia Noel, Amy Otto, Jessica Pettigrew, Debra Rubinstein, Linda Semler, Cheryl F. Smith, Elizabeth Venditti, Valarie Weinzierl, Katherine V. Williams, Tara Wilson, Richard F. Arakaki, Renee W. Latimer, Narleen K. Baker-Ladao, Mae K. Isonaga, Ralph Beddow, Nina E. Bermudez, Lorna Dias, Jillian Inouye, Marjorie K. Mau, John S. Melish, Kathy Mikami, Pharis Mohideen, Sharon K. Odom, Raynette U. Perry, Robin E. Yamamoto, William C. Knowler, Norman Cooeyate, Mary A. Hoskin, Carol A. Percy, Alvera Enote, Camille Natewa, Kelly J. Acton, Vickie L. Andre, Rosalyn Barber, Shandiin Begay, Peter H. Bennett, Mary Beth Benson, Evelyn C. Bird, Brenda A. Broussard, Brian C. Bucca, Marcella Chavez, Sherron Cook, Jeff Curtis, Tara Dacawyma, Matthew S. Doughty, Roberta Duncan, Charlotte Dodge, Cyndy Edgerton, Jacqueline M. Ghahate, Justin Glass, Martia Glass, Dorothy Gohdes, Wendy Grant, Robert L. Hanson, Ellie Horse, Louise E. Ingraham, Merry Jackson, Priscilla Jay, Roylen S. Kaskalla, Kathleen M. Kobus, Jonathan Krakoff, Jason Kurland, Catherine Manus, Cherie McCabe, Sara Michaels, Tina Morgan, Yolanda Nashboo, Julie A. Nelson, Steven Poirier, Evette Polczynski, Christopher Piromalli, Jeanine Roumain, Debra Rowse, Robert J. Roy, Sandra Sangster, Janet Sewenemewa, Miranda Smart, Darryl Tonemah, Charlton Wilson, Michelle Yazzie, Raymond Bain, Sarah Fowler, Marinella Temprosa, Michael D. Larsen, Tina Brenneman, Sharon L. Edelstein, Solome Abebe, Julie Bamdad, Melanie Barkalow, Joel Bethepu, Tsedenia Bezabeh, Nicole Butler, Jackie Callaghan, Caitlin E. Carter, Costas Christophi, Gregory M. Dwyer, Mary Foulkes, Yuping Gao, Robert Gooding, Adrienne Gottlieb, Kristina L. Grimes, Nisha Grover-Fairchild, Lori Haffner, Heather Hoffman, Kathleen Jablonski, Tara L. Jones, Richard Katz, Preethy Kolinjivadi, John M. Lachin, Pamela Mucik, Robert Orlosky, Qing Pan, Susan Reamer, James Rochon, Alla Sapozhnikova, Hanna Sherif, Charlotte Stimpson, Ashley Hogan Tjaden, Fredricka Walker-Murray, Elizabeth M. Venditti, Andrea M. Kriska, Valerie Weinzierl, Jessica Harting, F. Alan Aldrich, John Albers, Greg Strylewicz, R. Eastman, Judith Fradkin, Sanford Garfield, Edward Gregg, Morton B. Brown, David Altshuler, Liana K. Billings, Maegan Harden, Toni I. Pollin, Alan R. Shuldiner, Paul W. Franks, and Marie-France Hivert

Subjects
Male, Aging, Endocrinology, Diabetes and Metabolism, primary prevention, Overweight, Cardiovascular, Medical and Health Sciences, lcsh:Diseases of the endocrine glands. Clinical endocrinology, law.invention, Impaired glucose tolerance, 0302 clinical medicine, Sex hormone-binding globulin, Randomized controlled trial, law, Sex Hormone-Binding Globulin, polycyclic compounds, skin and connective tissue diseases, reproductive and urinary physiology, biology, DPP Research Group, Diabetes, Metformin, type 2, 030220 oncology & carcinogenesis, diabetes mellitus, Female, Clinical care/Education/Nutrition, medicine.symptom, hormones, hormone substitutes, and hormone antagonists, medicine.drug, medicine.medical_specialty, Diabetes risk, hormone, Clinical Trials and Supportive Activities, Clinical Sciences, 030209 endocrinology & metabolism, Placebo, 03 medical and health sciences, Clinical Research, Internal medicine, Diabetes mellitus, Health Sciences, Glucose Intolerance, Diabetes Mellitus, medicine, Humans, Obesity, Life Style, Metabolic and endocrine, Nutrition, lcsh:RC648-665, business.industry, Prevention, life style, medicine.disease, Estrogen, Diabetes Mellitus, Type 2, biology.protein, 3.1 Primary prevention interventions to modify behaviours or promote wellbeing, sense organs, business
Abstract

IntroductionSex hormone binding globulin (SHBG) levels are reported to be inversely associated with diabetes risk. It is unknown whether diabetes prevention interventions increase SHBG and whether resultant changes in SHBG affect diabetes risk. The purpose of this analysis was to determine whether intensive lifestyle intervention (ILS) or metformin changed circulating SHBG and if resultant changes influenced diabetes risk in the Diabetes Prevention Program (DPP).Research design and methodsThis is a secondary analysis from the DPP (1996–2001), a randomized trial of ILS or metformin versus placebo on diabetes risk over a mean follow-up of 3.2 years. The DPP was conducted across 27 academic study centers in the USA. Men, premenopausal and postmenopausal women without hormone use in the DPP were evaluated. The DPP included overweight/obese persons with elevated fasting glucose and impaired glucose tolerance. Main outcomes measures were changes in SHBG levels at 1 year and risk of diabetes over 3 years.ResultsILS resulted in significantly higher increases (postmenopausal women: pConclusionsLifestyle intervention may be associated with favorable changes in circulating SHBG, which is largely due to changes in adiposity. Changes in circulating SHBG do not independently predict reductions in diabetes incidence.

Published
2020

4. Genetic Modulation of Lipid Profiles following Lifestyle Modification or Metformin Treatment: The Diabetes Prevention Program

Author

James M. Ignaut, Kathy Ngo, Yuping Gao, Roylen S. Kaskalla, Kellie Smith, Margaret Kocal, Patrick J. Boyle, Peggy Gibbs, Lorna Dias, Richard P. Donahue, Deloris Heard, Javiva Horne, Jewel Mendoza, Samia Das, Cheryl F. Smith, Stacy Rubtchinsky, Susie M. Kelly, Kathleen A. Jablonski, Richard Arakaki, Elise Zimmerman, Kenneth S. Polonsky, Toni I. Pollin, Judith E. Soberman, Mary Beth Benson, Jeanine Roumain, Justin Glass, Mary Lou Carrion-Petersen, Jill P. Crandall, Wilfred Y. Fujimoto, Wendy Grant, Rosalyn Barber, Khan Akbar, Catherine Behrends, Roberta Duncan, Jose C. Florez, David M. Nathan, Ping Zhang, Claresa Levatan, Pentti Rautaharju, Steven Poirier, Cathryn F. Oldmixon, Carolyn Johannes, Patricia Katz, Patrice G. Saab, Maria Budget, Pamela Mucik, Jeanne M. Clark, Mark E. Molitch, Alexandra Poulos, Sharon L. Edelstein, Sheila Steinke, Valerie Goldman, Enrico Cagliero, Kristin David, Maureen Passaro, Yabing Li, Marizel Quitingon, Robert Moran, Louise E. Ingraham, Elizabeth M. Venditti, Evette Polczynski, Marsha Miller, Marie Smith, Caren G. Solomon, Anne Lowe, Maryanne Nicosia, Farida Rautaharju, Elizabeth Barrett-Connor, Shandiin Begay, Sharon D. Jackson, Tara L. Jones, James H. Warram, Tina Brenneman, Margaret J. Matulik, Lisa Testaverde, Marjorie K. Mau, George A. Bray, Rena R. Wing, Lisa Clifford, Andrew W. Taylor, Elissa Violino, Paul Cassanova-Romero, William B. Applegate, Fannie E. Smith, Kristine A. Viscovich, Alicia Noel, Barbara Eberhardt, Edward W. Gregg, Ellie Horse, Sofya M Rubinchik, Cormarie Wernimont, Patricia Rowe, Donna H. Ryan, Doris A. Hernandez-McGinnis, Janet Sewenemewa, Mary Beth Pena, Sara Michaels, Linda Semler, Amy D. Otto, Donald A. Williamson, David D. McPherson, Kieren J. Mather, Kirsten Czech, Hermes Florez, Jonathan Scheindlin, Charles Campbell, Evelyn C. Bird, Tracy Jones, Nancy D. Rowland, Linda M. Delahanty, Vickie L. Andre, Donald C. Simonson, Angela L. Brown, Michelle Kerr, Edward S. Horton, Zhu Ming Zhang, Margaret Mills, Alla Sapozhnikova, Edward W. Lipkin, Marion S. Kirkman, Ellen S. Rooney, Robert Orlosky, Julio V. Santiago, Emily Sullivan, Jeanette Calles, Mike Reidy, Lascelles Kirby, William C. Knowler, Catherine Manus, Paula C. Vicknair, Elizabeth J. Mayer-Davis, Willette Senter, Samuel S. Engel, Ysela Gonzales, Sandra Foo, Dorothy Pompi, Steve Jones, Sharon Hall, Robert R. Henry, Sujata Jinagouda, Beverly D. Porter, Fredricka Walker-Murray, Mary A. Hoskin, Iris W. Culbert, Michelle Cook, Steven E. Kahn, H. Shamoon, Frank L. Greenway, Enrique Caballero, Valerie McLymont, Marian L. Fitzgibbon, Carolyn King, David W. Price, Leslie F. Atler, Christopher D. Saudek, Frederick L. Brancati, Judith Wylie-Rosett, Brent VanDorsten, Marcella Chavez, Ronald J. Prineas, N. Grover, Beverly Williams-Cleaves, Catherine DeSandre, Mohammed F. Saad, Ronald A. Arky, Ronald B. Goldberg, Raed E. Imseis, Alexis Bouffard, Jerrold M. Olefsky, Joel Zonszein, Carissa M. Smith, Marinella Temprosa, Greg Strylewicz, Maria G. Montez, Gretchen Youssef, David A. Ehrmann, Janice Freel, Dace L. Trence, Robert E. Ratner, Susan Jeffries, Richard C. Eastman, Andrea M. Kriska, Dione Lenz, Kathleen E. Lawton, Cindy Evans, Neil H. White, Henry Mosley, Susan Cola, William H. Herman, Jean Smith, Alafia Samuels, Larry B. Ballonoff, Yolanda F. Dotson, Merry Jackson, Ann R. Semenske, Diane Larsen, Janet O. Brown, Tina Morgan, Simona Szerdi Janesch, Kerry J. Stewart, Jacqueline M. Ghahate, Ernestine Brown, Kathy Xapthalamous, Narleen K. Baker-Ladao, Maureen Malloy, Richard T. Tulley, Constance Pepe, Mary E. Murphy, Solome Abebe, Jill Crandall, Tracy Kellum, Lucy Ryder, David B. Allison, Samuel Dagogo-Jack, Steven V. Edelman, Ted Ganiats, Jeanne Charleston, James O. Hill, Renee W. Latimer, Sandra L. Frieson, Robert L. Hanson, F. Alan Aldrich, Barry J. Goldstein, Denise R. Anderson, Om P. Ganda, Helen M. Seagle, Gretchen E H van Wye, Monica Mullen, David S. Schade, Santica M. Marcovina, Jeffery J. Zachwieja, Mimi M. Giles, Janene L. Canady, Liane Cox, Madelyn L. Wheeler, John C. Guare, Helen Lambeth, Cheryl K H Johnson, Lynne Lichtermann, Alan R. Shuldiner, Susan Roston, Geraldine Boggs, Bonnie T. Jortberg, Paris Roach, Elsie Adorno, Arlene Martinez, Qing Pan, Pamela A. Schinleber, Jillian Inouye, Kathy Parkes, Katherine Horak, Elizabeth A. Walker, Carol Percy, Perpetua Magpuri, Michelle Yazzie, Cyndy Edgerton, Melvin J. Prince, Ralph Beddow, Sandra Sangster, Laura H. Morris, Carlos Lorenzo, Carmen A. Larreal, Richard J. Katz, Claudia Conzues, Gabriel Uwaifo, Juliet Ojito, Lynne Delve, William H. Polonsky, Julie A. Nelson, Raymond P. Bain, Mark R. Burge, Anna Giannella, Bart Clark, Renee Reinhart, Nancy Pemberton, Norman Cooeyate, Ryan Gilligan, Wayman W. Cheatham, Alan M. Jacobsen, Crystal J. Howard-Century, Sue Shapiro, Louann Harris, Jarred McAteer, Helena Duffy, Trevor J. Orchard, Marcia L. Jackson, Heather Turgeon, Sanford A. Garfield, Jonathan Krakoff, Debra Rowse, Jocelyn Pan, Patricia V. Nash, Kathy Abbott, Pamela G. Watson, James Rochon, M. Kaye Kramer, Paula Williamson, Betty M. Kennedy, Susan Harrier, Jose F. Caro, Richard R. Rubin, Megan Lyman, Kristina L. Grimes, Boyd E. Metzger, Priscilla Jay, Paul W. Franks, Ruthanne Hilbrich, Ellen W. Seely, B. Ned Calonge, Sundar R. D. Mudaliar, Tara Dacawyma, Marybeth Bryant, Abbas E. Kitabchi, Deborah A. Sanford, Renee Liberoni, Angela M. Hadden, Allison Friedler, Charlton Wilson, Valarie A. Weinzierl, Martia Glass, Michael L. Jeffirs, F. Xavier Pi-Sunyer, Elizabeth R. Stamm, John Spandorfer, Wylie L. McNabb, Janet Tobian, Yolanda Nashboo, Edwin S. Fineberg, Caroline Abbas, Amer Rassam, Hooman Oktaei, Robert H. Knopp, Vanessa Bradley, Charlotte Stimpson, Qurashia Manjoo, Marlene Frazier, Dorothy Gohdes, David Kessler, Gaye Koenning, Raynette U. Perry, Lily M K Rutledge, Amy R. Sherman, Catherine M. Champagne, Therese Franklin, Ellen J. Anderson, Arlette C. Perry, Lori Haffner, Darryl Tonemah, Charles McKitrick, Rebecca Culyba, Jennifer C. Lovejoy, Nancy J. Aronoff, Laurie Bissett, Jane E. Lee, Richard F. Hamman, Hanna Sherif, Julia A. St. Amant, Diana Leos, Judith E. Fradkin, David G. Marrero, Mariana K. Johnson, Michael Bryer-Ash, Lisa Chai, Deloris Johnson, Teresa Alexander, Jacqueline P. Burke, Edwin B. Fisher, Miriam A. Boraz, Jarred B. McAteer, Paul I.W. de Bakker, Tracy Whittington, Pharis Mohideen, John M. Lachin, Peter H. Bennett, Karen M. Callaphan, Kenneth G. Smith, Kimberly Loman, Sharon K. Odom, Karen Vejvoda, Susan Barr, L. Delahanty, Catherine Bavido-Arrage, Brenda A. Broussard, Daniel H. O'Leary, Dawn Jiggetts, Helen Martinez, Brenda Montgomery, Debra Waters, Carmen Pal, Tara Wilson, Nadege Longchamp, Lyn M. Kula, Katherine V. Williams, Martha Farago, Judith G. Regensteiner, Asha K. Nair, Karwyn S. Adams, Hope Joseph, Ana Santiago, Marjorie Bronsord, Emma Hurt, Lee E. Melancon, Michelle Marr, Jackie Callaghan, Dana Schweizer, Kathleen M. Kobus, Matthew S. Doughty, Shelley R. Hoyer, Stacey Kloiber, Steven M. Haffner, Sarah E. Fowler, Julie A. Bamdad, Lisa L. Smith, Clara Smith, David Altshuler, Fonda G. Guillory, Jadell Mendez, Thomas Pitts, April A. Herbert, Kathy Mikami, Kelly J. Acton, Andrew J. Sarkin, Tamara Isakova, and Allison, David B

Subjects
Male, Cancer Research, Magnetic Resonance Spectroscopy, 030204 cardiovascular system & hematology, Cardiovascular, chemistry.chemical_compound, 0302 clinical medicine, Endocrinology, Weight loss, Risk Factors, Genetics (clinical), 0303 health sciences, medicine.diagnostic_test, Diabetes, Single Nucleotide, Middle Aged, Metformin, 3. Good health, Cholesterol, Cardiovascular Diseases, Medicine, Female, medicine.symptom, Type 2, medicine.drug, Research Article, Adult, medicine.medical_specialty, Drugs and Devices, HDL, lcsh:QH426-470, Lipoproteins, Biology, Endocrinology and Diabetes, Polymorphism, Single Nucleotide, LDL, 03 medical and health sciences, Clinical Research, Internal medicine, Diabetes mellitus, Weight Loss, Diabetes Mellitus, Genetics, medicine, Humans, Hypoglycemic Agents, Polymorphism, Allele, Molecular Biology, Life Style, Metabolic and endocrine, Ecology, Evolution, Behavior and Systematics, Genetic Association Studies, Triglycerides, Nutrition, 030304 developmental biology, Dyslipidemias, Diabetic Endocrinology, Prevention, Cholesterol, HDL, Lipid metabolism, Cholesterol, LDL, Diabetes Mellitus Type 2, medicine.disease, Lipid Metabolism, Diabetes Prevention Program Research Group, lcsh:Genetics, chemistry, Diabetes Mellitus, Type 2, Pharmacogenetics, Lipid profile, Developmental Biology, Lipoprotein
Abstract

Weight-loss interventions generally improve lipid profiles and reduce cardiovascular disease risk, but effects are variable and may depend on genetic factors. We performed a genetic association analysis of data from 2,993 participants in the Diabetes Prevention Program to test the hypotheses that a genetic risk score (GRS) based on deleterious alleles at 32 lipid-associated single-nucleotide polymorphisms modifies the effects of lifestyle and/or metformin interventions on lipid levels and nuclear magnetic resonance (NMR) lipoprotein subfraction size and number. Twenty-three loci previously associated with fasting LDL-C, HDL-C, or triglycerides replicated (P = 0.04–1×10−17). Except for total HDL particles (r = −0.03, P = 0.26), all components of the lipid profile correlated with the GRS (partial |r| = 0.07–0.17, P = 5×10−5–1×10−19). The GRS was associated with higher baseline-adjusted 1-year LDL cholesterol levels (β = +0.87, SEE±0.22 mg/dl/allele, P = 8×10−5, P interaction = 0.02) in the lifestyle intervention group, but not in the placebo (β = +0.20, SEE±0.22 mg/dl/allele, P = 0.35) or metformin (β = −0.03, SEE±0.22 mg/dl/allele, P = 0.90; P interaction = 0.64) groups. Similarly, a higher GRS predicted a greater number of baseline-adjusted small LDL particles at 1 year in the lifestyle intervention arm (β = +0.30, SEE±0.012 ln nmol/L/allele, P = 0.01, P interaction = 0.01) but not in the placebo (β = −0.002, SEE±0.008 ln nmol/L/allele, P = 0.74) or metformin (β = +0.013, SEE±0.008 nmol/L/allele, P = 0.12; P interaction = 0.24) groups. Our findings suggest that a high genetic burden confers an adverse lipid profile and predicts attenuated response in LDL-C levels and small LDL particle number to dietary and physical activity interventions aimed at weight loss., Author Summary The study included 2,993 participants from the Diabetes Prevention Program, a randomized clinical trial of intensive lifestyle intervention, metformin treatment, and placebo control. We examined associations between 32 gene variants that have been reproducibly associated with dyslipidemia and concentrations of lipids and NMR lipoprotein particle sizes and numbers. We also examined whether genetic background influences a person's response to cardioprotective interventions on lipid levels. Our analysis, which focused on determining whether common genetic variants impact the effects of cardioprotective interventions on lipid and lipoprotein particle size, shows that in persons with a high genetic risk score the benefit of intensive lifestyle intervention on LDL and small LDL particle levels is substantially diminished; this information may be informative for the targeted prevention of dyslipidemia, as it suggests that genetics might help identify persons in whom lifestyle intervention is likely to be an effective treatment for elevated lipids and lipoproteins. The NMR subfraction analyses provide novel insight into the biology of dyslipidemia by illustrating how numerous genetic variants that have previously been associated with lipid levels also modulate NMR lipoprotein particle sizes and number. This information may be informative for the targeted prevention of cardiovascular disease.

Published
2012

5. Initiation of prandial insulin therapy with AIR inhaled insulin or insulin lispro in patients with type 2 diabetes: A randomized noninferiority trial

Author

Zvonko Milicevic, Jeffrey A. Ferguson, Masako Nakano, Pierre-Yves Berclaz, Jorge Luiz Gross, Gildred Colon-Vega, Sandra Althouse, Ramon Ortiz-Carasquillo, and Janet Tobian

Subjects
Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Vital Capacity, Type 2 diabetes, Body Mass Index, Endocrinology, Internal medicine, Diabetes mellitus, Forced Expiratory Volume, Administration, Inhalation, medicine, Insulin lispro, Humans, Hypoglycemic Agents, Insulin, In patient, Lung, Aged, Glycated Hemoglobin, Insulin Lispro, business.industry, Patient Selection, Body Weight, Inhaled insulin, Middle Aged, medicine.disease, Metformin, Medical Laboratory Technology, Diabetes Mellitus, Type 2, Drug Therapy, Combination, Female, business, Prandial insulin, medicine.drug
Abstract

Insulin initiation in patients with type 2 diabetes is often delayed because of concerns about injections. Our objective was to compare the effects of AIR inhaled insulin (Eli Lilly and Co., Indianapolis, IN) (AIR is a registered trademark of Alkermes, Inc., Cambridge, MA) with those of injectable insulin on glycemic control and safety.This was planned as a 24-month, open-label, randomized study in adults with diabetes inadequately controlled by one or more oral antihyperglycemic medications (OAMs). Following a 2-week baseline period, patients continued OAMs and were randomized to AIR insulin (n = 208) or insulin lispro (n = 203) before meals. The primary end point was hemoglobin A1C (A1C) change from baseline to 6 months. Noninferiority was established if the upper limit of the 95% confidence interval of the difference in A1C change wasor =0.4%.Early termination of the study diminished the number of patients for the 12- and 24-month analyses, but not for the primary 6-month end point analyses. AIR insulin and injectable insulin groups had comparable baseline A1C values (8.18% vs. 8.21%, respectively). Change in A1C from baseline to 6-month end point was similar (least squares mean, -0.81 +/- 0.09% and -0.87 +/- 0.09%; 95% confidence interval for the difference -0.117, 0.234; P = 0.51) and so were final A1C values of 7.36% and 7.31% for AIR insulin and injectable insulin, respectively. At 6 months, no differences were observed in eight-point profiles, overall and nocturnal hypoglycemia, and weight gain. Greater decreases in spirometry were observed in the AIR insulin group at 12 months. Cough was the most frequently reported adverse event (20% [AIR insulin] vs. 10% [insulin lispro]; P = 0.002).Treatment with AIR insulin resulted in similar improvement in glycemic control compared with insulin lispro. More frequent cough and greater decrease in spirometry were observed with AIR insulin.

Published
2009

6. Safety and efficacy of AIR inhaled insulin compared with subcutaneous insulin in patients having diabetes and asthma: A 12-month, randomized, noninferiority trial

Author

Cory R Heilmann, Ernesto Ang, Jeffrey A. Ferguson, Mary K Lawrence, Pierre-Yves Berclaz, David M. Webb, and Janet Tobian

Subjects
Adult, Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Injections, Subcutaneous, Vital Capacity, Type 2 diabetes, law.invention, Body Mass Index, Diabetes Complications, Endocrinology, Randomized controlled trial, law, Internal medicine, Diabetes mellitus, Forced Expiratory Volume, Administration, Inhalation, medicine, Diabetes Mellitus, Humans, Insulin, Age of Onset, Asthma, Aged, Glycated Hemoglobin, Carbon Monoxide, business.industry, Smoking, Middle Aged, medicine.disease, Confidence interval, Surgery, Medical Laboratory Technology, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Concomitant, Female, business, Body mass index
Abstract

Long-term safety and efficacy of AIR((R)) inhaled insulin (Eli Lilly and Co., Indianapolis, IN) (AIR is a registered trademark of Alkermes, Inc., Cambridge, MA) in patients with diabetes and concomitant lung disease remain to be established.This 1-year, randomized, open-label, active comparator, two-arm, parallel study compared the safety and efficacy of AIR insulin to subcutaneous (SC) insulin in patients having type 1 or type 2 diabetes and asthma. Patients with type 2 diabetes continued taking their prestudy oral antihyperglycemic medication.Change in hemoglobin A1C from baseline to end point was similar for the AIR insulin and SC insulin groups (-0.063 +/- 0.128% and -0.315 +/- 0.128% respectively, P = 0.105), but noninferiority failed to be achieved (the upper limit of the 95% confidence interval [-0.053, 0.555] was0.4%). The total daily prandial dose increased more in the AIR insulin group than in the SC insulin group (0.150 U/kg and 0.044 U/kg, respectively, P = 0.002). Safety profiles were generally comparable between treatments. At end point, forced expiratory volume in 1 s (FEV(1))/forced vital capacity (FVC) postbronchodilator (-0.016 +/- 0.005 vs. 0.002 +/- 0.005, P = 0.006) and diffusing capacity of the lung for carbon monoxide (-1.214 +/- 0.325 mL/min/torr vs. -0.383 +/- 0.311 mL/min/torr, P = 0.028) both decreased more in the AIR insulin group than in the SC insulin group, but the differences were not present at follow-up. FEV(1) and FVC were similar between treatment groups at end point. Incidences of hypoglycemia were comparable between groups. Insulin antibody binding increased more in the AIR insulin group. Cough was the most common adverse event; however, there was no difference in incidence between the AIR insulin (15.3%) and SC insulin (12.4%) treatment groups (P = 0.572).In patients who have diabetes and asthma, AIR insulin demonstrated glycemic efficacy similar to SC insulin. Additionally, the safety profile of AIR insulin in patients with and without asthma is consistent.

Published
2009

7. Two-year efficacy and safety of AIR inhaled insulin in patients with type 1 diabetes: An open-label randomized controlled trial

Author

Haitao Gao, Jeffrey A. Ferguson, Janet Tobian, David M. Webb, Satish K. Garg, Jeffrey R. Gates, Chantal Mathieu, Pierre-Yves Berclaz, and Nadeem Rais

Subjects
Adult, Blood Glucose, Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Injections, Subcutaneous, Vital Capacity, Insulin Glargine, law.invention, Body Mass Index, Endocrinology, Randomized controlled trial, law, Internal medicine, Diabetes mellitus, Forced Expiratory Volume, Administration, Inhalation, medicine, Humans, Hypoglycemic Agents, Insulin, In patient, Intensive care medicine, Glycemic, Glycated Hemoglobin, Type 1 diabetes, Insulin Lispro, business.industry, Body Weight, Inhaled insulin, Middle Aged, medicine.disease, Hypoglycemia, Insulin, Long-Acting, Medical Laboratory Technology, Diabetes Mellitus, Type 1, Female, Open label, Safety, business
Abstract

Patients with type 1 diabetes require intensive insulin therapy for optimal glycemic control. AIR((R)) inhaled insulin (system from Eli Lilly and Company, Indianapolis, IN) (AIR is a registered trademark of Alkermes, Inc., Cambridge, MA) may be an efficacious and safe alternative to subcutaneously injected (SC) mealtime insulin.This was a Phase 3, 2-year, randomized, open-label, active-comparator, parallel-group study in 385 patients with type 1 diabetes who were randomly assigned to receive AIR insulin or SC insulin (regular human insulin or insulin lispro) at mealtimes. Both groups received insulin glargine once daily. Efficacy measures included mean change in hemoglobin A1C (A1C) from baseline to end point, eight-point self-monitored blood glucose profiles, and insulin dosage. Safety assessments included hypoglycemic events, pulmonary function tests, adverse events, and insulin antibody levels.In both treatment groups, only 20% of subjects reached the target of A1C7.0%. A significant A1C difference of 0.44% was seen favoring SC insulin, with no difference between the groups in insulin doses or hypoglycemic events at end point. Patients in both treatment groups experienced progressive decreases in lung function, but larger (reversible) decrements in diffusing capacity of the lung for carbon monoxide (DL(CO)) were associated with AIR insulin treatment. Greater weight gain was seen with SC insulin treatment.The AIR inhaled insulin program was terminated by the sponsor prior to availability of any Phase 3 data for reasons unrelated to safety or efficacy. Despite early termination, this trial provides evidence that AIR insulin was less efficacious in lowering A1C and was associated with a greater decrease in DL(CO) and increased incidence of cough than SC insulin in patients with type 1 diabetes.

Published
2009

8. The impact of diabetes and age on pulmonary function: data from the National Health and Nutrition Examination Survey

Author

Pierre-Yves Berclaz, Robert O. Crapo, Diana L. Swanson, Haitao Gao, Robert L. Jensen, David M. Webb, and Janet Tobian

Subjects
Adult, Male, medicine.medical_specialty, National Health and Nutrition Examination Survey, Endocrinology, Diabetes and Metabolism, Vital Capacity, Pulmonary function testing, FEV1/FVC ratio, Endocrinology, NHANES III, Internal medicine, Diabetes mellitus, Forced Expiratory Volume, Internal Medicine, medicine, Diabetes Mellitus, Humans, Lung function, Aged, business.industry, Age Factors, General Medicine, respiratory system, Middle Aged, medicine.disease, Health Surveys, United States, respiratory tract diseases, Physical therapy, Female, business
Abstract

Using data from NHANES III, we evaluated the effect of diabetes on the age-related decline in lung function. The Diabetes group ( n = 471) had significantly lower mean FEV 1 and FVC values than the No Diabetes group ( n = 4317), but pulmonary function declined with increasing age at a similar rate for both groups.

Published
2008

9. The AIR inhaled insulin system: system components and pharmacokinetic/glucodynamic data

Author

Douglas B. Muchmore, Janet Tobian, Bernard L. Silverman, and Amparo de la Peña

Subjects
Blood Glucose, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Phases of clinical research, Pharmacology, Endocrinology, Pharmacokinetics, Internal medicine, Diabetes mellitus, Administration, Inhalation, medicine, Insulin lispro, Humans, Insulin, Glycemic, Aerosols, Insulin Lispro, Inhalation, business.industry, Nebulizers and Vaporizers, Inhaled insulin, Equipment Design, medicine.disease, Medical Laboratory Technology, business, medicine.drug
Abstract

The diabetes epidemic and lack of adequate glycemic control in patients with diabetes emphasize the need for alternative diabetes treatment strategies. Although many new compounds have been developed, insulin remains the most potent agent for controlling glycemia. Inhaled insulin systems have been developed to alleviate the fear of insulin injections and to improve the convenience of insulin administration. The AIR Inhaled Insulin System being developed by Eli Lilly (Indianapolis, IN) and Alkermes (Cambridge, MA) uses AIR particle technology to deliver dry powder insulin to the deep lung. Pharmacokinetic and glucodynamic data in Phase 1 clinical trials have demonstrated that AIR Insulin is rapidly absorbed with prolonged insulin exposure and action compared to insulin lispro. AIR Insulin has also been shown to have dose equivalence and dose reproducibility across a range of doses, and it has been shown that three inhalations of the 2 U-equivalent dose can be interchanged with one 6 U-equivalent dose. A Phase 2 study demonstrated preference for AIR Insulin over subcutaneous injectable insulins, and a recent study reported that the system is easy to teach and use. Several Phase 3 studies are currently underway to further investigate the safety and efficacy and to evaluate the system's intention to meet provider and patient expectations.

Published
2007

10. Use of the Continuous Glucose Monitoring System to guide therapy in patients with insulin-treated diabetes: a randomized controlled trial

Author

Claresa S. Levetan, Jorge H. Mestman, Wendy Lane, John J. Mastrototaro, Robert J. Tanenberg, Anne Peters Harmel, Janet Tobian, Bruce W. Bode, and Todd M. Gross

Subjects
Adult, Blood Glucose, Male, medicine.medical_specialty, medicine.medical_treatment, Hypoglycemia, Risk Assessment, Sensitivity and Specificity, Severity of Illness Index, law.invention, Insulin Infusion Systems, Randomized controlled trial, law, Diabetes management, Reference Values, Diabetes mellitus, Internal medicine, medicine, Confidence Intervals, Humans, Insulin, Prospective Studies, Glycemic, Aged, Monitoring, Physiologic, business.industry, Glucose meter, Blood Glucose Self-Monitoring, General Medicine, Middle Aged, medicine.disease, Surgery, Hemoglobin A, Diabetes Mellitus, Type 1, Treatment Outcome, Hyperglycemia, Female, business
Abstract

OBJECTIVE To show improved glycemic control in patients with insulin-treated diabetes after adjustments to the diabetes management plan based on either continuous glucose monitoring using the Continuous Glucose Monitoring System (CGMS) or frequent self-monitoring of blood glucose (SMBG) using a home blood glucose meter. PATIENTS AND METHODS From January to September 2000, patients aged 19 to 76 years with insulin-treated diabetes were assigned to insulin therapy adjustments based on either CGMS or SMBG values. At the end of the study, patients in both groups used the CGMS for 3 days; these values were used to calculate measures of hypoglycemia. Repeated-measures analysis of variance with post hoc comparisons were used to test differences in hemoglobin A 1c levels and hypoglycemia between the 2 study groups. RESULTS A total of 128 patients were enrolled in the study. Nineteen discontinued study participation, leaving 51 in the CGMS group and 58 in the SMBG group. No significant differences were noted in demographics or baseline characteristics between the 2 groups. There were no significant differences in hemoglobin A 1c levels between the CGMS group and the SMBG group at baseline (9.1%±1.1% vs 9.0%±1.0%, P =.70), and both groups showed statistically significant ( P >.001) and similar ( P =.95) improvement in hemoglobin A 1c levels after 12 weeks of study. However, the CGMS group had a significantly shorter duration of hypoglycemia (sensor glucose, ≤60 mg/dL) at week 12 of the study (49.4±40.8 vs 81.0±61.1 minutes per event, P =.009). CONCLUSION Use of the CGMS to guide therapy adjustments in patients with insulin-treated diabetes reduces the duration of hypoglycemia compared with therapy adjustments guided by SMBG values alone.

Published
2004

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