Clinical trial NCT00360815: Diabetes Control and Complications Trial (DCCT)
Official title: Diabetes Control and Complications Trial (DCCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2006-08-07
Enrollment: 1441
Sex: ALL
Minimum age (years): 13
Maximum age (years): 39
Standard ages: CHILD
ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background. Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications.

Methods. A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.


Eligibility criteria: Eligibility Criteria:

* The major criteria for eligibility included insulin dependence, as evidenced by deficient C-peptide secretion; an age of 13 to 39 years; and the absence of hypertension, hypercholesterolemia, and severe diabetic complications or medical conditions. To be eligible for the primary-prevention cohort, patients were required to have had insulin dependent diabetes mellitus (IDDM) for one to five years, to have no retinopathy as detected by seven-field stereoscopic fundus photography, and to have urinary albumin excretion of less than 40 mg per 24 hours. To be eligible for the secondary-intervention cohort, the patients were required to have IDDM for 1 to 15 years, to have very-mild to moderate nonproliferative retinopathy, and to have urinary albumin excretion of less than 200 mg per 24 hours.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Tampa
country: United States
facility: University of South Florida College of Medicine
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Springfield
country: United States
facility: DCCT Central Autonomic Coding Unit
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Rockville
country: United States
facility: George Washington University, Biostatistics Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Joslin Diabetes Center, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan, Sattelite-Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
city: Minneapolis
country: United States
facility: DCCT Central Nutrition Coding Unit
state: Minnesota
city: Minneapolis
country: United States
facility: DCCT Central ECG Reading Unit
state: Minnesota
city: Minneapolis
country: United States
facility: DCCT Central Biochemistry Laboratory
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Foundation
state: Minnesota
city: Columbia
country: United States
facility: Backup DCCT Central HbA1c Lab
state: Missouri
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: St. Louis
country: United States
facility: Washington University at St. Louis
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico School of Medicine
state: New Mexico
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: New York
country: United States
facility: Cornell University Medical College, The New York Hospital
state: New York
city: Cleveland
country: United States
facility: Case Western Reserve University, Lakeside Hospital
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania, The Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Children's Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: DCCT Central Neurobehavioral Coding Unit
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University, Diabetes Research and Training Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: University of Texas
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Madison
country: United States
facility: DCCT Central Ophthalmologic Reading Unit, Fundus Photo Reading Center
state: Wisconsin
city: Vancouver
country: Canada
facility: University of Washington (British Columbia Satellite)
state: British Columbia
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto, Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Vanderbilt University
name: Oscar B. Crofford, M.D.
role: STUDY_CHAIR
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Carolyn Siebert, M.P.H.
role: STUDY_DIRECTOR
affiliation: George Washington University
name: Patricia A. Cleary, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lachin JM, Bebu I, Gao X, Nathan DM, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group. Association of Estimated Time-in-Range Capillary Glucose Levels Versus HbA1c With Progression of Microvascular Complications in the Diabetes Control and Complications Trial. Diabetes Care. 2022 Oct 1;45(10):2445-2448. doi: 10.2337/dc21-2298.
citation: Martin CL, Trapani VR, Backlund JC, Lee P, Braffett BH, Bebu I, Lachin JM, Jacobson AM, Gubitosi-Klug R, Herman WH; DCCT/EDIC Research Group. Physical Function in Middle-aged and Older Adults With Type 1 Diabetes: Long-term Follow-up of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study. Diabetes Care. 2022 Sep 1;45(9):2037-2045. doi: 10.2337/dc21-2119.
citation: Jacobson AM, Braffett BH, Erus G, Ryan CM, Biessels GJ, Luchsinger JA, Bebu I, Gubitosi-Klug RA, Desiderio L, Lorenzi GM, Trapani VR, Lachin JM, Bryan RN, Habes M, Nasrallah IM; DCCT/EDIC Research Group. Brain Structure Among Middle-aged and Older Adults With Long-standing Type 1 Diabetes in the DCCT/EDIC Study. Diabetes Care. 2022 Aug 1;45(8):1779-1787. doi: 10.2337/dc21-2438.
citation: Gubitosi-Klug RA, Braffett BH, Bebu I, Johnson ML, Farrell K, Kenny D, Trapani VR, Meadema-Mayer L, Soliman EZ, Pop-Busui R, Lachin JM, Bergenstal RM, Tamborlane WV. Continuous Glucose Monitoring in Adults With Type 1 Diabetes With 35 Years Duration From the DCCT/EDIC Study. Diabetes Care. 2022 Mar 1;45(3):659-665. doi: 10.2337/dc21-0629.
citation: Carlson NE, Horton KW, Hokanson JE, Cleary PA, Jacobs DR Jr, Brunzell JD, Purnell JQ; DCCT/EDIC research group. Weight gain trajectories and obesity rates in intensive and conventional treatments of type 1 diabetes from the DCCT compared with a control population without diabetes. Diabet Med. 2022 May;39(5):e14794. doi: 10.1111/dme.14794. Epub 2022 Jan 26.
citation: Perkins BA, Bebu I, Gao X, Karger AB, Hirsch IB, Karanchi H, Molitch ME, Zinman B, Lachin JM, de Boer IH. Early Trajectory of Estimated Glomerular Filtration Rate and Long-term Advanced Kidney and Cardiovascular Complications in Type 1 Diabetes. Diabetes Care. 2022 Mar 1;45(3):585-593. doi: 10.2337/dc21-1883.
citation: Boyko EJ, Zelnick LR, Braffett BH, Pop-Busui R, Cowie CC, Lorenzi GM, Gubitosi-Klug R, Zinman B, de Boer IH. Risk of Foot Ulcer and Lower-Extremity Amputation Among Participants in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study. Diabetes Care. 2022 Feb 1;45(2):357-364. doi: 10.2337/dc21-1816.
citation: Steigmann L, Miller R, Trapani VR, Giannobile WV, Braffett BH, Pop-Busui R, Lorenzi G, Herman WH, Sarma AV; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Type 1 diabetes and oral health: Findings from the Epidemiology of Diabetes Interventions and Complications (EDIC) study. J Diabetes Complications. 2022 Apr;36(4):108120. doi: 10.1016/j.jdiacomp.2021.108120. Epub 2022 Jan 3.
citation: Polak JF, Backlund JC, Budoff M, Raskin P, Bebu I, Lachin JM; DCCT/EDIC Research Group. Coronary Artery Disease Events and Carotid Intima-Media Thickness in Type 1 Diabetes in the DCCT/EDIC Cohort. J Am Heart Assoc. 2021 Dec 21;10(24):e022922. doi: 10.1161/JAHA.121.022922. Epub 2021 Dec 7.
citation: Pop-Busui R, Braffett BH, Wessells H, Herman WH, Martin CL, Jacobson AM, Sarma AV. Diabetic Peripheral Neuropathy and Urological Complications in Type 1 Diabetes: Findings From the Epidemiology of Diabetes Interventions and Complications Study. Diabetes Care. 2022 Jan 1;45(1):119-126. doi: 10.2337/dc21-1276.
citation: Jenkins AJ, Braffett BH, Basu A, Bebu I, Dagogo-Jack S, Orchard TJ, Wallia A, Lopes-Virella MF, Garvey WT, Lachin JM, Lyons TJ; DCCT/EDIC Research Group. Serum urate and cardiovascular events in the DCCT/EDIC study. Sci Rep. 2021 Jul 9;11(1):14182. doi: 10.1038/s41598-021-90785-4.
citation: Jacobson AM, Ryan CM, Braffett BH, Gubitosi-Klug RA, Lorenzi GM, Luchsinger JA, Trapani VR, Bebu I, Chaytor N, Hitt SM, Farrell K, Lachin JM; DCCT/EDIC Research Group. Cognitive performance declines in older adults with type 1 diabetes: results from 32 years of follow-up in the DCCT and EDIC Study. Lancet Diabetes Endocrinol. 2021 Jul;9(7):436-445. doi: 10.1016/S2213-8587(21)00086-3. Epub 2021 May 27.
citation: Gubitosi-Klug R, Gao X, Pop-Busui R, de Boer IH, White N, Aiello LP, Miller R, Palmer J, Tamborlane W, Wallia A, Kosiborod M, Lachin JM, Bebu I; DCCT/EDIC Research Group. Associations of Microvascular Complications With the Risk of Cardiovascular Disease in Type 1 Diabetes. Diabetes Care. 2021 Jul;44(7):1499-1505. doi: 10.2337/dc20-3104. Epub 2021 May 12.
citation: Bebu I, Keshavarzi S, Gao X, Braffett BH, Canty AJ, Herman WH, Orchard TJ, Dagogo-Jack S, Nathan DM, Lachin JM, Paterson AD; DCCT/EDIC Research Group. Genetic Risk Factors for CVD in Type 1 Diabetes: The DCCT/EDIC Study. Diabetes Care. 2021 Jun;44(6):1309-1316. doi: 10.2337/dc20-2388. Epub 2021 Apr 21.
citation: Gubitosi-Klug RA, Braffett BH, Hitt S, Arends V, Uschner D, Jones K, Diminick L, Karger AB, Paterson AD, Roshandel D, Marcovina S, Lachin JM, Steffes M, Palmer JP; DCCT/EDIC Research Group. Residual beta cell function in long-term type 1 diabetes associates with reduced incidence of hypoglycemia. J Clin Invest. 2021 Feb 1;131(3):e143011. doi: 10.1172/JCI143011.
citation: Hainsworth DP, Gao X, Bebu I, Das A, Olmos de Koo L, Barkmeier AJ, Tamborlane W, Lachin JM, Aiello LP; Diabetes Control and Complications Trial and Follow-up Epidemiology of Diabetes Interventions and Complications Research Group. Refractive Error and Retinopathy Outcomes in Type 1 Diabetes: The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study. Ophthalmology. 2021 Apr;128(4):554-560. doi: 10.1016/j.ophtha.2020.09.014. Epub 2020 Sep 14.
citation: Bebu I, Braffett BH, Schade D, Sivitz W, Malone JI, Pop-Busui R, Lorenzi GM, Lee P, Trapani VR, Wallia A, Herman WH, Lachin JM; DCCT/EDIC Research Group. An Observational Study of the Equivalence of Age and Duration of Diabetes to Glycemic Control Relative to the Risk of Complications in the Combined Cohorts of the DCCT/EDIC Study. Diabetes Care. 2020 Oct;43(10):2478-2484. doi: 10.2337/dc20-0226. Epub 2020 Aug 11.
citation: Chen Z, Miao F, Braffett BH, Lachin JM, Zhang L, Wu X, Roshandel D, Carless M, Li XA, Tompkins JD, Kaddis JS, Riggs AD, Paterson AD; DCCT/EDIC Study Group; Natarajan R. DNA methylation mediates development of HbA1c-associated complications in type 1 diabetes. Nat Metab. 2020 Aug;2(8):744-762. doi: 10.1038/s42255-020-0231-8. Epub 2020 Jul 20.
citation: Braffett BH, Gubitosi-Klug RA, Albers JW, Feldman EL, Martin CL, White NH, Orchard TJ, Lopes-Virella M, Lachin JM, Pop-Busui R; DCCT/EDIC Research Group. Risk Factors for Diabetic Peripheral Neuropathy and Cardiovascular Autonomic Neuropathy in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study. Diabetes. 2020 May;69(5):1000-1010. doi: 10.2337/db19-1046. Epub 2020 Feb 12.
citation: Bebu I, Schade D, Braffett B, Kosiborod M, Lopes-Virella M, Soliman EZ, Herman WH, Bluemke DA, Wallia A, Orchard T, Lachin JM; DCCT/EDIC Research Group. Risk Factors for First and Subsequent CVD Events in Type 1 Diabetes: The DCCT/EDIC Study. Diabetes Care. 2020 Apr;43(4):867-874. doi: 10.2337/dc19-2292. Epub 2020 Jan 30.
citation: Braffett BH, Dagogo-Jack S, Bebu I, Sivitz WI, Larkin M, Kolterman O, Lachin JM; DCCT/EDIC Research Group. Response to Comment on Braffett et al. Association of Insulin Dose, Cardiometabolic Risk Factors, and Cardiovascular Disease in Type 1 Diabetes During 30 Years of Follow-up in the DCCT/EDIC Study. Diabetes Care 2019;42:657-664. Diabetes Care. 2019 Aug;42(8):e137. doi: 10.2337/dci19-0026. No abstract available.
citation: Sarma AV, Hotaling JM, de Boer IH, Dunn RL, Oerline MK, Singh K, Goldberg J, Jacobson A, Braffett B, Herman WH, Pop-Busui R, Wessells H; DCCT/EDIC Research Group. Blood pressure, antihypertensive medication use, and risk of erectile dysfunction in men with type I diabetes. J Hypertens. 2019 May;37(5):1070-1076. doi: 10.1097/HJH.0000000000001988.
citation: Perkins BA, Bebu I, de Boer IH, Molitch M, Tamborlane W, Lorenzi G, Herman W, White NH, Pop-Busui R, Paterson AD, Orchard T, Cowie C, Lachin JM; Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group. Risk Factors for Kidney Disease in Type 1 Diabetes. Diabetes Care. 2019 May;42(5):883-890. doi: 10.2337/dc18-2062. Epub 2019 Mar 4.
citation: Hainsworth DP, Bebu I, Aiello LP, Sivitz W, Gubitosi-Klug R, Malone J, White NH, Danis R, Wallia A, Gao X, Barkmeier AJ, Das A, Patel S, Gardner TW, Lachin JM; Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group. Risk Factors for Retinopathy in Type 1 Diabetes: The DCCT/EDIC Study. Diabetes Care. 2019 May;42(5):875-882. doi: 10.2337/dc18-2308. Epub 2019 Mar 4.
citation: Braffett BH, Dagogo-Jack S, Bebu I, Sivitz WI, Larkin M, Kolterman O, Lachin JM; DCCT/EDIC Research Group. Association of Insulin Dose, Cardiometabolic Risk Factors, and Cardiovascular Disease in Type 1 Diabetes During 30 Years of Follow-up in the DCCT/EDIC Study. Diabetes Care. 2019 Apr;42(4):657-664. doi: 10.2337/dc18-1574. Epub 2019 Feb 6.
citation: Wessells H, Braffett BH, Holt SK, Jacobson AM, Kusek JW, Cowie C, Dunn RL, Sarma AV; DCCT/EDIC Study Group. Burden of Urological Complications in Men and Women With Long-standing Type 1 Diabetes in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Cohort. Diabetes Care. 2018 Oct;41(10):2170-2177. doi: 10.2337/dc18-0255. Epub 2018 Aug 13.
citation: Herman WH, Braffett BH, Kuo S, Lee JM, Brandle M, Jacobson AM, Prosser LA, Lachin JM. What are the clinical, quality-of-life, and cost consequences of 30 years of excellent vs. poor glycemic control in type 1 diabetes? J Diabetes Complications. 2018 Oct;32(10):911-915. doi: 10.1016/j.jdiacomp.2018.05.007. Epub 2018 Jun 12.
citation: Herman WH, Braffett BH, Kuo S, Lee JM, Brandle M, Jacobson AM, Prosser LA, Lachin JM. The 30-year cost-effectiveness of alternative strategies to achieve excellent glycemic control in type 1 diabetes: An economic simulation informed by the results of the diabetes control and complications trial/epidemiology of diabetes interventions and complications (DCCT/EDIC). J Diabetes Complications. 2018 Oct;32(10):934-939. doi: 10.1016/j.jdiacomp.2018.06.005. Epub 2018 Jun 12.
citation: Basu A, Jenkins AJ, Stoner JA, Zhang Y, Klein RL, Lopes-Virella MF, Garvey WT, Schade DS, Wood J, Alaupovic P, Lyons TJ; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Apolipoprotein-defined lipoprotein subclasses, serum apolipoproteins, and carotid intima-media thickness in T1D. J Lipid Res. 2018 May;59(5):872-883. doi: 10.1194/jlr.P080143. Epub 2018 Mar 25.
citation: de Boer IH, Gao X, Bebu I, Hoofnagle AN, Lachin JM, Paterson A, Perkins BA, Saenger AK, Steffes MW, Zinman B, Molitch ME. Biomarkers of tubulointerstitial damage and function in type 1 diabetes. BMJ Open Diabetes Res Care. 2017 Nov 14;5(1):e000461. doi: 10.1136/bmjdrc-2017-000461. eCollection 2017.
citation: Purnell JQ, Braffett BH, Zinman B, Gubitosi-Klug RA, Sivitz W, Bantle JP, Ziegler G, Cleary PA, Brunzell JD; DCCT/EDIC Research Group. Impact of Excessive Weight Gain on Cardiovascular Outcomes in Type 1 Diabetes: Results From the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study. Diabetes Care. 2017 Dec;40(12):1756-1762. doi: 10.2337/dc16-2523.
citation: Kim C, Pan Y, Braffett BH, Arends VL, Steffes MW, Wessells H, Sarma AV; DCCT/EDIC Research Group. Anti-Mullerian hormone and its relationships with subclinical cardiovascular disease and renal disease in a longitudinal cohort study of women with type 1 diabetes. Womens Midlife Health. 2017 Aug 18;3:5. doi: 10.1186/s40695-017-0023-9. eCollection 2017.
citation: Bebu I, Braffett BH, Pop-Busui R, Orchard TJ, Nathan DM, Lachin JM; DCCT/EDIC Research Group. The relationship of blood glucose with cardiovascular disease is mediated over time by traditional risk factors in type 1 diabetes: the DCCT/EDIC study. Diabetologia. 2017 Oct;60(10):2084-2091. doi: 10.1007/s00125-017-4374-4. Epub 2017 Jul 16.
citation: Gubitosi-Klug RA, Braffett BH, White NH, Sherwin RS, Service FJ, Lachin JM, Tamborlane WV; Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group. Risk of Severe Hypoglycemia in Type 1 Diabetes Over 30 Years of Follow-up in the DCCT/EDIC Study. Diabetes Care. 2017 Aug;40(8):1010-1016. doi: 10.2337/dc16-2723. Epub 2017 May 26.
citation: DCCT/EDIC Research Group; Nathan DM, Bebu I, Hainsworth D, Klein R, Tamborlane W, Lorenzi G, Gubitosi-Klug R, Lachin JM. Frequency of Evidence-Based Screening for Retinopathy in Type 1 Diabetes. N Engl J Med. 2017 Apr 20;376(16):1507-1516. doi: 10.1056/NEJMoa1612836.
citation: Lachin JM, Bebu I, Bergenstal RM, Pop-Busui R, Service FJ, Zinman B, Nathan DM; DCCT/EDIC Research Group. Association of Glycemic Variability in Type 1 Diabetes With Progression of Microvascular Outcomes in the Diabetes Control and Complications Trial. Diabetes Care. 2017 Jun;40(6):777-783. doi: 10.2337/dc16-2426. Epub 2017 Apr 12.
citation: Armstrong AC, Ambale-Venkatesh B, Turkbey E, Donekal S, Chamera E, Backlund JY, Cleary P, Lachin J, Bluemke DA, Lima JA; DCCT/EDIC Research Group. Association of Cardiovascular Risk Factors and Myocardial Fibrosis With Early Cardiac Dysfunction in Type 1 Diabetes: The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study. Diabetes Care. 2017 Mar;40(3):405-411. doi: 10.2337/dc16-1889. Epub 2016 Dec 16.
citation: de Boer IH, Gao X, Cleary PA, Bebu I, Lachin JM, Molitch ME, Orchard T, Paterson AD, Perkins BA, Steffes MW, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group. Albuminuria Changes and Cardiovascular and Renal Outcomes in Type 1 Diabetes: The DCCT/EDIC Study. Clin J Am Soc Nephrol. 2016 Nov 7;11(11):1969-1977. doi: 10.2215/CJN.02870316. Epub 2016 Oct 24.
citation: Lenherr SM, Clemens JQ, Braffett BH, Dunn RL, Cleary PA, Kim C, Herman WH, Hotaling JM, Jacobson AM, Brown JS, Wessells H, Sarma AV; DCCT/EDIC Research Group. Glycaemic control and risk of incident urinary incontinence in women with Type 1 diabetes: results from the Diabetes Control and Complications Trial and Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study. Diabet Med. 2016 Nov;33(11):1528-1535. doi: 10.1111/dme.13126. Epub 2016 Apr 24.
citation: Writing Group for the DCCT/EDIC Research Group. Coprogression of Cardiovascular Risk Factors in Type 1 Diabetes During 30 Years of Follow-up in the DCCT/EDIC Study. Diabetes Care. 2016 Sep;39(9):1621-30. doi: 10.2337/dc16-0502. Epub 2016 Jul 19.
citation: Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Group. Mortality in Type 1 Diabetes in the DCCT/EDIC Versus the General Population. Diabetes Care. 2016 Aug;39(8):1378-83. doi: 10.2337/dc15-2399. Epub 2016 Jul 13.
citation: Hotaling JM, Sarma AV, Patel DP, Braffett BH, Cleary PA, Feldman E, Herman WH, Martin CL, Jacobson AM, Wessells H, Pop-Busui R; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Cardiovascular Autonomic Neuropathy, Sexual Dysfunction, and Urinary Incontinence in Women With Type 1 Diabetes. Diabetes Care. 2016 Sep;39(9):1587-93. doi: 10.2337/dc16-0059. Epub 2016 Jun 28.
citation: Roshandel D, Klein R, Klein BE, Wolffenbuttel BH, van der Klauw MM, van Vliet-Ostaptchouk JV, Atzmon G, Ben-Avraham D, Crandall JP, Barzilai N, Bull SB, Canty AJ, Hosseini SM, Hiraki LT, Maynard J, Sell DR, Monnier VM, Cleary PA, Braffett BH; DCCT/EDIC Research Group; Paterson AD. New Locus for Skin Intrinsic Fluorescence in Type 1 Diabetes Also Associated With Blood and Skin Glycated Proteins. Diabetes. 2016 Jul;65(7):2060-71. doi: 10.2337/db15-1484. Epub 2016 Apr 12.
citation: Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group. Risk Factors for Cardiovascular Disease in Type 1 Diabetes. Diabetes. 2016 May;65(5):1370-9. doi: 10.2337/db15-1517. Epub 2016 Feb 19.
citation: Sell DR, Sun W, Gao X, Strauch C, Lachin JM, Cleary PA, Genuth S; DCCT/EDIC Research Group; Monnier VM. Skin collagen fluorophore LW-1 versus skin fluorescence as markers for the long-term progression of subclinical macrovascular disease in type 1 diabetes. Cardiovasc Diabetol. 2016 Feb 11;15:30. doi: 10.1186/s12933-016-0343-3.
citation: Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Group. Intensive Diabetes Treatment and Cardiovascular Outcomes in Type 1 Diabetes: The DCCT/EDIC Study 30-Year Follow-up. Diabetes Care. 2016 May;39(5):686-93. doi: 10.2337/dc15-1990. Epub 2016 Feb 9.
citation: Porta M, Toppila I, Sandholm N, Hosseini SM, Forsblom C, Hietala K, Borio L, Harjutsalo V, Klein BE, Klein R, Paterson AD; DCCT/EDIC Research Group; Groop PH; FinnDiane Study Group. Variation in SLC19A3 and Protection From Microvascular Damage in Type 1 Diabetes. Diabetes. 2016 Apr;65(4):1022-30. doi: 10.2337/db15-1247. Epub 2015 Dec 30.
citation: Kim C, Bebu I, Braffett B, Cleary PA, Arends V, Steffes M, Wessells H, Orchard T, Sarma AV; DCCT/EDIC Research Group. Testosterone and cardiac mass and function in men with type 1 diabetes in the Epidemiology of Diabetes Interventions and Complications Study (EDIC). Clin Endocrinol (Oxf). 2016 May;84(5):693-9. doi: 10.1111/cen.12990. Epub 2016 Jan 25.
citation: Writing Team for the DCCT/EDIC Research Group; Gubitosi-Klug RA, Sun W, Cleary PA, Braffett BH, Aiello LP, Das A, Tamborlane W, Klein R. Effects of Prior Intensive Insulin Therapy and Risk Factors on Patient-Reported Visual Function Outcomes in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Cohort. JAMA Ophthalmol. 2016 Feb;134(2):137-45. doi: 10.1001/jamaophthalmol.2015.4606.
citation: Kim C, Pop-Busui R, Braffett B, Cleary PA, Bebu I, Wessells H, Orchard T, Sarma AV; DCCT/E.D.I.C. Research Group. Testosterone Concentrations and Cardiovascular Autonomic Neuropathy in Men with Type 1 Diabetes in the Epidemiology of Diabetes Interventions and Complications Study (EDIC). J Sex Med. 2015 Nov;12(11):2153-9. doi: 10.1111/jsm.13029. Epub 2015 Nov 12.
citation: Monnier VM, Sun W, Gao X, Sell DR, Cleary PA, Lachin JM, Genuth S; DCCT/EDIC Research Group. Skin collagen advanced glycation endproducts (AGEs) and the long-term progression of sub-clinical cardiovascular disease in type 1 diabetes. Cardiovasc Diabetol. 2015 Sep 5;14:118. doi: 10.1186/s12933-015-0266-4.
citation: Eny KM, Orchard TJ, Miller RG, Maynard J, Grant DM, Costacou T, Cleary PA, Braffett BH, Paterson AD; DCCT/EDIC Research Group. Caffeine Consumption Contributes to Skin Intrinsic Fluorescence in Type 1 Diabetes. Diabetes Technol Ther. 2015 Oct;17(10):726-34. doi: 10.1089/dia.2015.0017. Epub 2015 Jul 20.
citation: Lipska KJ, Montori VM. ACP Journal Club. In type 1 diabetes, intensive insulin therapy for 6.5 y reduced mortality at 27 y compared with usual care. Ann Intern Med. 2015 May 19;162(10):JC12. doi: 10.7326/ACPJC-2015-162-10-012. No abstract available.
citation: Bharucha AE, Batey-Schaefer B, Cleary PA, Murray JA, Cowie C, Lorenzi G, Driscoll M, Harth J, Larkin M, Christofi M, Bayless M, Wimmergren N, Herman W, Whitehouse F, Jones K, Kruger D, Martin C, Ziegler G, Zinsmeister AR, Nathan DM; Diabetes Control and Complications Trial-Epidemiology of Diabetes Interventions and Complications Research Group. Delayed Gastric Emptying Is Associated With Early and Long-term Hyperglycemia in Type 1 Diabetes Mellitus. Gastroenterology. 2015 Aug;149(2):330-9. doi: 10.1053/j.gastro.2015.05.007. Epub 2015 May 14.
citation: DCCT/EDIC Research Group; Aiello LP, Sun W, Das A, Gangaputra S, Kiss S, Klein R, Cleary PA, Lachin JM, Nathan DM. Intensive diabetes therapy and ocular surgery in type 1 diabetes. N Engl J Med. 2015 Apr 30;372(18):1722-33. doi: 10.1056/NEJMoa1409463.
citation: Pop-Busui R, Hotaling J, Braffett BH, Cleary PA, Dunn RL, Martin CL, Jacobson AM, Wessells H, Sarma AV; DCCT/EDIC Research Group. Cardiovascular autonomic neuropathy, erectile dysfunction and lower urinary tract symptoms in men with type 1 diabetes: findings from the DCCT/EDIC. J Urol. 2015 Jun;193(6):2045-51. doi: 10.1016/j.juro.2014.12.097. Epub 2015 Jan 10.
citation: Writing Group for the DCCT/EDIC Research Group; Orchard TJ, Nathan DM, Zinman B, Cleary P, Brillon D, Backlund JY, Lachin JM. Association between 7 years of intensive treatment of type 1 diabetes and long-term mortality. JAMA. 2015 Jan 6;313(1):45-53. doi: 10.1001/jama.2014.16107.
citation: Sarma AV, Hotaling J, Dunn RL, Cleary PA, Braffett BH, Kim C, Martin C, Herman W, Gatcomb P, Jacobson AM, Holt SK, Wessells H; DCCT/EDIC Research Group. Poor glycemic control is associated with reduced prostate specific antigen concentrations in men with type 1 diabetes. J Urol. 2015 Mar;193(3):786-93. doi: 10.1016/j.juro.2014.08.115. Epub 2014 Sep 11.
citation: Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group; Lachin JM, White NH, Hainsworth DP, Sun W, Cleary PA, Nathan DM. Effect of intensive diabetes therapy on the progression of diabetic retinopathy in patients with type 1 diabetes: 18 years of follow-up in the DCCT/EDIC. Diabetes. 2015 Feb;64(2):631-42. doi: 10.2337/db14-0930. Epub 2014 Sep 9.
citation: DCCT/EDIC research group. Effect of intensive diabetes treatment on albuminuria in type 1 diabetes: long-term follow-up of the Diabetes Control and Complications Trial and Epidemiology of Diabetes Interventions and Complications study. Lancet Diabetes Endocrinol. 2014 Oct;2(10):793-800. doi: 10.1016/S2213-8587(14)70155-X. Epub 2014 Jul 17.
citation: Eny KM, Lutgers HL, Maynard J, Klein BE, Lee KE, Atzmon G, Monnier VM, van Vliet-Ostaptchouk JV, Graaff R, van der Harst P, Snieder H, van der Klauw MM, Sell DR, Hosseini SM, Cleary PA, Braffett BH, Orchard TJ, Lyons TJ, Howard K, Klein R, Crandall JP, Barzilai N, Milman S, Ben-Avraham D; LifeLines Cohort Study Group; DCCT/EDIC Research Group; Wolffenbuttel BH, Paterson AD. GWAS identifies an NAT2 acetylator status tag single nucleotide polymorphism to be a major locus for skin fluorescence. Diabetologia. 2014 Aug;57(8):1623-34. doi: 10.1007/s00125-014-3286-9. Epub 2014 Jun 17.
citation: McGee P, Steffes M, Nowicki M, Bayless M, Gubitosi-Klug R, Cleary P, Lachin J, Palmer J; DCCT/EDIC Research Group. Insulin secretion measured by stimulated C-peptide in long-established Type 1 diabetes in the Diabetes Control and Complications Trial (DCCT)/ Epidemiology of Diabetes Interventions and Complications (EDIC) cohort: a pilot study. Diabet Med. 2014 Oct;31(10):1264-8. doi: 10.1111/dme.12504. Epub 2014 Jun 9.
citation: Larkin ME, Barnie A, Braffett BH, Cleary PA, Diminick L, Harth J, Gatcomb P, Golden E, Lipps J, Lorenzi G, Mahony C, Nathan DM; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Musculoskeletal complications in type 1 diabetes. Diabetes Care. 2014 Jul;37(7):1863-9. doi: 10.2337/dc13-2361. Epub 2014 Apr 10.
citation: Buschur E, Sarma AV, Pietropaolo M, Dunn RL, Braffett BH, Cleary PA, Cowie C, Larkin ME, Wessells H, Nathan DM, Kim C; DCCT/EDIC Research Group. Self-reported autoimmune disease by sex in the diabetes control and complications trial/epidemiology of diabetes interventions and complications (DCCT/EDIC) study. Diabetes Care. 2014 Feb;37(2):e28-9. doi: 10.2337/dc13-1890. No abstract available.
citation: de Boer IH, Sun W, Cleary PA, Lachin JM, Molitch ME, Zinman B, Steffes MW; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Research Group. Longitudinal changes in estimated and measured GFR in type 1 diabetes. J Am Soc Nephrol. 2014 Apr;25(4):810-8. doi: 10.1681/ASN.2013050557. Epub 2013 Dec 5.
citation: Nathan DM, Bayless M, Cleary P, Genuth S, Gubitosi-Klug R, Lachin JM, Lorenzi G, Zinman B; DCCT/EDIC Research Group. Diabetes control and complications trial/epidemiology of diabetes interventions and complications study at 30 years: advances and contributions. Diabetes. 2013 Dec;62(12):3976-86. doi: 10.2337/db13-1093. No abstract available.
citation: Kim C, Cleary PA, Cowie CC, Braffett BH, Dunn RL, Larkin ME, Gatcomb PM, Wessells HB, Nathan DM, Sarma AV; DCCT/EDIC Research Group. Effect of glycemic treatment and microvascular complications on menopause in women with type 1 diabetes in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) cohort. Diabetes Care. 2014;37(3):701-8. doi: 10.2337/dc13-1746. Epub 2013 Oct 29.
citation: Orchard TJ, Sun W, Cleary PA, Genuth SM, Lachin JM, McGee P, Paterson AD, Raskin P, Anbinder Y, Levy AP; DCCT/EDIC Research Group. Haptoglobin genotype and the rate of renal function decline in the diabetes control and complications trial/epidemiology of diabetes interventions and complications study. Diabetes. 2013 Sep;62(9):3218-23. doi: 10.2337/db13-0256. Epub 2013 Jun 12.
citation: Genuth SM, Backlund JY, Bayless M, Bluemke DA, Cleary PA, Crandall J, Lachin JM, Lima JA, Miao C, Turkbey EB; DCCT/EDIC Research Group. Effects of prior intensive versus conventional therapy and history of glycemia on cardiac function in type 1 diabetes in the DCCT/EDIC. Diabetes. 2013 Oct;62(10):3561-9. doi: 10.2337/db12-0546. Epub 2013 Mar 21.
citation: Turkbey EB, Redheuil A, Backlund JY, Small AC, Cleary PA, Lachin JM, Lima JA, Bluemke DA; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Aortic distensibility in type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2380-7. doi: 10.2337/dc12-0393. Epub 2013 Mar 8.
citation: Pop-Busui R, Cleary PA, Braffett BH, Martin CL, Herman WH, Low PA, Lima JAC, Bluemke DA; DCCT/EDIC Research Group. Association between cardiovascular autonomic neuropathy and left ventricular dysfunction: DCCT/EDIC study (Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications). J Am Coll Cardiol. 2013 Jan 29;61(4):447-454. doi: 10.1016/j.jacc.2012.10.028. Epub 2012 Dec 19.
citation: Purnell JQ, Zinman B, Brunzell JD; DCCT/EDIC Research Group. The effect of excess weight gain with intensive diabetes mellitus treatment on cardiovascular disease risk factors and atherosclerosis in type 1 diabetes mellitus: results from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study (DCCT/EDIC) study. Circulation. 2013 Jan 15;127(2):180-7. doi: 10.1161/CIRCULATIONAHA.111.077487. Epub 2012 Dec 4.
citation: Kramer JR, Bayless ML, Lorenzi GM, Ziegler GK, Larkin ME, Lackaye ME, Harth J, Diminick LJ, Anderson KL, Braffett BH, Cleary PA; DCCT/EDIC Study Group. Participant characteristics and study features associated with high retention rates in a longitudinal investigation of type 1 diabetes mellitus. Clin Trials. 2012 Dec;9(6):798-805. doi: 10.1177/1740774512458986. Epub 2012 Oct 1.
citation: de Boer IH, Sachs MC, Cleary PA, Hoofnagle AN, Lachin JM, Molitch ME, Steffes MW, Sun W, Zinman B, Brunzell JD; Diabetes Control and Complication Trial/Epidemiology of Diabetes Interventions and Complications Study Research Group. Circulating vitamin D metabolites and kidney disease in type 1 diabetes. J Clin Endocrinol Metab. 2012 Dec;97(12):4780-8. doi: 10.1210/jc.2012-2852. Epub 2012 Sep 18.
citation: Larkin ME, Lorenzi GM, Bayless M, Cleary PA, Barnie A, Golden E, Hitt S, Genuth S. Evolution of the study coordinator role: the 28-year experience in Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC). Clin Trials. 2012 Aug;9(4):418-25. doi: 10.1177/1740774512449532. Epub 2012 Jun 22.
citation: DCCT/EDIC Research Group; de Boer IH, Sun W, Cleary PA, Lachin JM, Molitch ME, Steffes MW, Zinman B. Intensive diabetes therapy and glomerular filtration rate in type 1 diabetes. N Engl J Med. 2011 Dec 22;365(25):2366-76. doi: 10.1056/NEJMoa1111732. Epub 2011 Nov 12.
citation: Turkbey EB, Backlund JY, Genuth S, Jain A, Miao C, Cleary PA, Lachin JM, Nathan DM, van der Geest RJ, Soliman EZ, Liu CY, Lima JA, Bluemke DA; DCCT/EDIC Research Group. Myocardial structure, function, and scar in patients with type 1 diabetes mellitus. Circulation. 2011 Oct 18;124(16):1737-46. doi: 10.1161/CIRCULATIONAHA.111.022327. Epub 2011 Sep 26.
citation: Gai N, Turkbey EB, Nazarian S, van der Geest RJ, Liu CY, Lima JA, Bluemke DA. T1 mapping of the gadolinium-enhanced myocardium: adjustment for factors affecting interpatient comparison. Magn Reson Med. 2011 May;65(5):1407-15. doi: 10.1002/mrm.22716. Epub 2010 Dec 16.
citation: Polak JF, Backlund JY, Cleary PA, Harrington AP, O'Leary DH, Lachin JM, Nathan DM; DCCT/EDIC Research Group. Progression of carotid artery intima-media thickness during 12 years in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study. Diabetes. 2011 Feb;60(2):607-13. doi: 10.2337/db10-0296.
citation: Nathan DM, Steffes MW, Sun W, Rynders GP, Lachin JM. Determining stability of stored samples retrospectively: the validation of glycated albumin. Clin Chem. 2011 Feb;57(2):286-90. doi: 10.1373/clinchem.2010.150250. Epub 2010 Oct 28.
citation: Larkin ME, Backlund JY, Cleary P, Bayless M, Schaefer B, Canady J, Nathan DM; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group. Disparity in management of diabetes and coronary heart disease risk factors by sex in DCCT/EDIC. Diabet Med. 2010 Apr;27(4):451-8. doi: 10.1111/j.1464-5491.2010.02972.x.
citation: Younes N, Cleary PA, Steffes MW, de Boer IH, Molitch ME, Rutledge BN, Lachin JM, Dahms W; DCCT/EDIC Research Group. Comparison of urinary albumin-creatinine ratio and albumin excretion rate in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications study. Clin J Am Soc Nephrol. 2010 Jul;5(7):1235-42. doi: 10.2215/CJN.07901109. Epub 2010 May 6.
citation: Molitch ME, Steffes M, Sun W, Rutledge B, Cleary P, de Boer IH, Zinman B, Lachin J; Epidemiology of Diabetes Interventions and Complications Study Group. Development and progression of renal insufficiency with and without albuminuria in adults with type 1 diabetes in the diabetes control and complications trial and the epidemiology of diabetes interventions and complications study. Diabetes Care. 2010 Jul;33(7):1536-43. doi: 10.2337/dc09-1098. Epub 2010 Apr 22.
citation: White NH, Sun W, Cleary PA, Tamborlane WV, Danis RP, Hainsworth DP, Davis MD; DCCT-EDIC Research Group. Effect of prior intensive therapy in type 1 diabetes on 10-year progression of retinopathy in the DCCT/EDIC: comparison of adults and adolescents. Diabetes. 2010 May;59(5):1244-53. doi: 10.2337/db09-1216. Epub 2010 Feb 11.
citation: Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group; Nathan DM, Zinman B, Cleary PA, Backlund JY, Genuth S, Miller R, Orchard TJ. Modern-day clinical course of type 1 diabetes mellitus after 30 years' duration: the diabetes control and complications trial/epidemiology of diabetes interventions and complications and Pittsburgh epidemiology of diabetes complications experience (1983-2005). Arch Intern Med. 2009 Jul 27;169(14):1307-16. doi: 10.1001/archinternmed.2009.193.
citation: White NH, Sun W, Cleary PA, Danis RP, Davis MD, Hainsworth DP, Hubbard LD, Lachin JM, Nathan DM. Prolonged effect of intensive therapy on the risk of retinopathy complications in patients with type 1 diabetes mellitus: 10 years after the Diabetes Control and Complications Trial. Arch Ophthalmol. 2008 Dec;126(12):1707-15. doi: 10.1001/archopht.126.12.1707.