Dcct trial summary

Dcct trial summary DEFAULT

Epidemiology of Diabetes Interventions and Complications (EDIC)

University of California, San DiegoSan Diego, California, United States, 92093 George Washington University, Biostatistics Center, Data Coordinating CenterBethesda, Maryland, United States, 20852 National Institutes of Health, National Institute of Diabetes and Digestive and Kidney DiseasesBethesda, Maryland, United States, 20892 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 University of MichiganAnn Arbor, Michigan, United States, 48109 Case Western Reserve University, Clinical Coordinating CenterCleveland, Ohio, United States, 44106 University of Toronto, Mount Sinai HospitalToronto, Ontario, Canada, M5t 3L9
Sours: https://www.clinicaltrials.gov/ct2/show/NCT00360893

Blood Glucose Control Studies for Type 1 Diabetes: DCCT and EDIC

The NIDDK funded the landmark Diabetes Control and Complications Trial (DCCT) to see if people with type 1 diabetes who kept their blood glucose levels as close to normal as safely possible with intensive diabetes treatment (three or more shots of insulin per day or an insulin pump with self-monitoring of blood glucose at least four times per day) could slow the development of eye, kidney, and nerve disease, compared with people who used the conventional treatment at the time of the study (one or two shots of insulin per day with daily self-monitoring of urine or blood glucose). The DCCT ended after 10 years in 1993—a year earlier than planned—when the study proved that participants who kept their blood glucose levels close to normal greatly lowered their chances of having eye, kidney, and nerve disease.

A follow-up study to the DCCT, the ongoing Epidemiology of Diabetes Interventions and Complications (EDIC) study, has continued to follow DCCT participants since 1994. EDIC has shown that there are long-term benefits of early and intensive blood glucose control on the future development of diabetes-related complications such as heart, eye, kidney, and nerve disease, and that early and intensive blood glucose control also lengthens life. EDIC has also shown that scheduling eye exams based on personal risk for retinopathy, rather than once a year, results in fewer eye exams, lower costs, and quicker diagnosis and treatment of advanced diabetic eye disease.

Findings from DCCT/EDIC have changed the way diabetes is treated worldwide. As a result of DCCT/EDIC and other studies, early and intensive blood glucose control is now the standard treatment for people with type 1 and some people with type 2 diabetes, and it helps people with diabetes live longer and healthier lives.

Diabetes Control and Complications Trial (DCCT)

DCCT Results

The DCCT showed that people with type 1 diabetes who kept their blood glucose levels as close to normal as safely possible with intensive diabetes treatment as early as possible in their disease had fewer diabetes-related health problems after 6.5 years, compared with people who used the conventional treatment.

DCCT showed that people who used intensive treatment lowered their risk of

  • diabetic eye disease by 76 percent; and advancement of eye disease by about half (54 percent), in people with some eye disease at the beginning of the study
  • diabetic kidney disease by 50 percent
  • diabetic nerve disease by 60 percent

Researchers were not able to show whether people who used intensive treatment lowered their risk of heart disease during the DCCT, because only a few people had heart disease during the study.

Participants who used intensive treatment had an average A1C of 7 percent, while participants who used the conventional treatment had an average A1C of 9 percent. The A1C blood test shows a person’s average blood glucose levels over the previous 2 to 3 months. A normal A1C value is 5.7 percent or less.

In the DCCT, the major side effect of intensive treatment was a higher risk for hypoglycemia, also called low blood glucose, which can be deadly if not treated immediately. Participants were taught how to treat hypoglycemia.

DCCT Study Size, Participant Demographics, and Study Design

The DCCT took place from 1983 to 1993. The study involved 1,441 volunteers, ages 13 to 39, and took place in 29 medical centers in the United States and Canada. At the start of the DCCT, participants had type 1 diabetes for at least 1 year, but no longer than 15 years, and had no or only early signs of diabetic eye or kidney disease.

DCCT participants were randomly assigned to one of the following groups

  • intensive diabetes treatment group. Participants took insulin three or more times per day by injection or an insulin pump and self-monitored their blood glucose levels four or more times a day. The treatment goal was to keep A1C levels as close to normal as safely possible. Participants met with their health care team monthly.
  • conventional diabetes treatment group. Participants used what was conventional diabetes treatment at the time (in the early 1980s): one or two shots of insulin a day with daily urine or blood glucose testing. Participants met with their health care team every 3 months.

Researchers followed participants for an average of 6.5 years and compared the study groups to see whether there was more eye, kidney, and nerve disease in one group or the other.

After DCCT ended, participants who used conventional treatment were taught about intensive treatment. Participants who continued into the EDIC follow-up study were transferred to their own health care team for medical care and were encouraged to use intensive treatment.

Epidemiology of Diabetes Interventions and Complications (EDIC) Study

EDIC Results

EDIC researchers are trying to understand how diabetes affects the body over time and the long-term benefits of a period of early and intensive blood glucose control in the development of later diabetes complications. EDIC has shown that early and intensive blood glucose control during the DCCT lowers the risk of

  • advanced diabetic eye disease by 49 percent, 18 years after the DCCT ended and eye surgery by 49 percent, 21 years after the DCCT ended
  • advanced kidney diseaseby 33 percent, 24 years after the DCCT ended
  • nerve problems by about 30 percent, 14 years after the DCCT ended
  • cardiovascular diseases (such as heart attack and stroke) by 30 percent, 22 years after the DCCT ended

DCCT participants who had tight control of their blood glucose levels had a 33 percent lower risk of death, 21 years after the DCCT ended. Historically, people with type 1 diabetes tended to die earlier than the general population. DCCT/EDIC researchers found that this earlier death can be reduced through careful management of blood glucose.

Additionally, EDIC has shown that personalizing the frequency of eye screenings for people with type 1 diabetes based on their risk of severe eye problems and A1C level would result in

  • fewer eye exams by 50 percent, lowering the overall cost of care by 1 billion dollars over 20 years
  • quicker diagnosis and treatment of advanced diabetic eye disease, a condition which can lead to vision loss

These long-term benefits occurred even though all participants had an average A1C of 8 percent during the 25-plus years of the EDIC study. Participants from the DCCT’s intensive treatment and conventional treatment groups had reached similar blood glucose levels about 5 years after EDIC began.

EDIC Study Size, Participant Demographics, and Study Design

The EDIC follow-up study started in 1994, enrolling 96 percent of the living DCCT participants at the beginning of the study. When EDIC began, participants who used conventional treatment were taught about intensive treatment, and received follow-up care from their own health care teams. The EDIC study is ongoing and includes the majority of the original surviving DCCT participants. These people continue to take part in a variety of studies concerning diabetes-related health problems, including hypoglycemia, irregular heartbeats, hearing loss, weakened bones, trouble thinking clearly, physical frailty, and problems with the eyes, kidneys, nerves, feet, bladder, and sexual function.

Researchers are also looking at the small amount of insulin that some EDIC participants continue to make to determine whether it improves their health.

Related Health Information

Related Studies

  • United Kingdom Prospective Diabetes Study. Researchers showed that controlling blood glucose levels in people with type 2 diabetes reduced the risk of diabetic eye disease and diabetic kidney disease.
  • Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study. Researchers compared standard practice guidelines with more intensive blood glucose and blood pressure management and control of abnormal blood fats in 10,000 people with type 2 diabetes, including those at especially high risk for cardiovascular disease. ACCORD researchers found that participants maintained good control of blood glucose levels during the study, however the risk of cardiovascular events such as heart attack, stroke, and death was not lowered with intensive control of blood pressure or treatment for abnormal blood fats.
  • SEARCH for Diabetes in Youth Study. Researchers found that rates of new diagnosed cases of type 1 and type 2 diabetes are increasing among youth in the United States. Researchers also found that teens and young adults with type 2 diabetes develop kidney, nerve, and eye diseases—as well as some risk factors for heart disease—more often than their peers with type 1 diabetes in the years shortly after diagnosis.

News Releases and Reports

Scientific Publications and Resources

  • DCCT and EDIC Study website
  • DCCT on ClinicalTrials.gov
  • EDIC on ClinicalTrials.gov
  • Study Documents and Materials from the NIDDK Central Repository
  • DCCT Grant Award information from the dkNET
  • EDIC Grant Award Information from dkNET
  • The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin dependent diabetes mellitus. New England Journal of Medicine. 1993;329(14):977–986.
  • Nathan DM, Cleary PA, Backlund JY, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. New England Journal of Medicine. 2005;353(25):2643–2653.
  • Martin CL, Albers GW, Pop-Busui R; DCCT/EDIC Research Group. Neuropathy and related findings in the diabetes control and complications trial/epidemiology of diabetes interventions and complications study. Diabetes Care. 2014;37(1): 31–38.
  • Orchard TJ, Nathan DM, Zinman B, et al. Association between seven years of intensive treatment of type 1 diabetes and long-term mortality. Journal of the American Medical Association. 2015;313(1):45–53.
  • The DCCT/EDIC Research Group, Aiello LP, Sun W, et al. Intensive diabetes therapy and ocular surgery in type 1 diabetes. New England Journal of Medicine. 2015;372(18):1722–1733.
  • The DCCT/EDIC Research Group. Intensive diabetes treatment and cardiovascular outcomes in type 1 diabetes: the DCCT/EDIC study 30-year follow-up. Diabetes Care. 2016;39(5):686–693.
  • Herman WH, Braffett BH, Kuo S, et al. What are the clinical, quality-of-life, and cost consequences of 30 years of excellent vs. poor glycemic control in type 1 diabetes?. Journal of Diabetes and Its Complications. 2018;32(10):911–915.
  • Herman WH, Braffett BH, Kuo S, et al. 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). Journal of Diabetes and Its Complications. 2018;32(10):934–939.
  • Bebu I, Schade D, Braffett B, et al.; DCCT/EDIC Research Group. Risk factors for first and subsequent CVD events in type 1 diabetes: the DCCT/EDIC study.Diabetes Care. 2020;43(4):867–874.
  • Braffett BH, Gubitosi-Klug RA, Albers JW, et al; DCCT/EDIC Study 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;69(5):1000–1010.

Last Reviewed August 2020

Sours: https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/blood-glucose-control-studies-type-1-diabetes-dcct-edic
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DCCT

Published

DCCT Research Group. "The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus". The New England Journal of Medicine. 1993. 329(14):977-986.
PubMed • Full text • PDF

Clinical Question

In patients with T1DM, how does strict glycemic control with intensive therapy compare with conventional therapy in preventing microvascular complications?

Bottom Line

Among patients with T1DM, strict glycemic control prevents up to 70% of microvascular complications, particularly retinopathy.

Major Points

The Diabetes Control and Complications Trial (DCCT) demonstrated that strict glycemic control targeting lower HbA1c goals among patients with T1DM can both delay the onset of retinopathy, nephropathy, and neuropathy and slow the progression of existing microvascular complications. This came at the expense of a threefold higher risk of hypoglycemia, underlying the fact that HbA1c goals should be tailored to the individual.

DCCT was unable to demonstrate a reduction in CV events, likely because the study population was relatively young at the time. However, EDIC and other follow-up studies did demonstrate such benefits.

Despite the fact that DCCT studied only patients with T1DM, many physicians began recommending strict glycemic control to patients with T2DM as well.

Design

  • Multicenter, parallel-group, randomized controlled trial
  • N=1,441
    • Primary prevention (n=726) with no retinopathy at baseline
    • Secondary intervention (n=715) with mild retinopathy at baseline
  • Setting: 29 international centers
  • Enrollment: 1983 to 1989
  • Mean follow-up: 6.5 years (9,300 patient-years)

Population

Inclusion Criteria

  • T1DM, as evidenced by deficient C-peptide secretion
  • Age: 13-39 years
  • To be eligible for primary prevention cohort:
    • T1DM for 1-5 years
    • No retinopathy as detected by seven-field stereoscopic fundus photography
    • Urinary albumin excretion ≥40 mg/day
  • To be eligible for secondary prevention cohort:
    • T1DM for 1-15 years
    • Very-mild-to-moderate nonproliferative retinopathy
    • Urinary albumin excretion ≤200 mg/day

Exclusion Criteria

  • T1DM diagnosed <1 year or >15 years prior to enrollment
  • T2DM
  • History of cardiovascular disease
  • Hypertension (BP ≥140/90 mmHg)
  • Hyperlipidemia
  • Serum creatinine ≥1.2 mg/dL or creatinine clearance ≤100 ml/min/1.73 m2 BSA
  • Severe diabetic complications (e.g., greater degrees of retinopathy)
  • Severe medical comorbidities

Baseline Characteristics

  • Mean age: 27 years
  • Male: 53%
  • White: 97%
  • Duration of T1DM: 2.6 years in primary-prevention vs 8.8 years in secondary-intervention
  • HbA1c: 8.9%
  • Mean blood glucose: 232 mg/dL
  • SBP 114 mm Hg, DBP 73 mm Hg
  • IBW: 104%
  • Current smokers: 19%
  • Serum LDL: 110

Interventions

  • Randomized to intensive vs. conventional therapy
  • Stratified according to primary-prevention and secondary-intervention cohorts at each center
  • Retinopathy assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
    • Scale of 25 steps which represent overall extent of retinopathy
    • Development or progression of retinopathy defined as sustained (≥6 month) change of ≥3 steps from baseline

Intensive therapy: injections of insulin ≥3 times daily or via external pump; dosages adjusted according to self-monitoring of blood glucose QID

  • Preprandial glucose between 70-120 mg/dL
  • Postprandial glucose <180 mg/dL
  • Weekly 3am glucose >65 mg/dL
  • Monthly HbA1c <6.05%
  • Appointments every 1 month and frequent telephone calls

Conventional therapy: injections of insulin one or two times daily; self-monitoring of urine or blood glucose daily, ± daily adjustments

  • Absence of symptoms attributable to glycosuria or hyperglycemia
  • Absence of ketonuria
  • Maintenance of normal group, development, IBW
  • Freedom from severe or frequent hypoglycemia
  • Appointments every 3 months

Outcomes

Comparisons are intensive vs. conventional therapy.

Primary Outcomes

Development of retinopathy (primary-prevention cohort)
6.0% vs 24.1% (RR 0.26; 95% CI 0.15-0.38; P<0.001)
Progress of retinopathy (secondary-intervention cohort)
21.2% vs 40.6% (RR 0.46; 95% CI 0.34-0.61; P<0.001)
Development of proliferative or severe non-proliferative retinopathy
(RR 0.53; 95% CI 0.33-0.86; P=0.011)
Microalbuminuria (urinary albumin excretion of ≥40 mg/24 hours)
34% reduction (P=0.04) in primary-prevention cohort
43% reduction (P=0.001) in secondary-intervention cohort
Albuminuria (urinary albumin excretion of ≥300 mg/24 hours)
56% reduction (P=0.01) in secondary-intervention cohort
Peripheral sensorimotor neuropathy
3% vs 10% (RR 0.30; P=0.006) in primary-prevention cohort at 5 years
7% vs 16% (RR 0.44; P<0.001) in secondary-intervention cohort at 5 years
Glycemic control
Mean glucose: 155 vs 231 mg/dL (P<0.001)
Mean HbA1c: 7.2% vs 9.1% (P<0.001); HbA1c reached nadir at 6 months in patients receiving intensive therapy

Subgroup Analysis

  • Intensive therapy consistently reduced risk of retinopathy and nephropathy in all subgroups in both cohorts among all clinics.
  • Baseline covariates, including age, sex, duration of T1DM, % IBW, level of retinopathy, mean BP, presence of clinical neuropathy, baseline HbA1c, history of smoking, and albuminuria

Adverse Events

Incidence of hypoglycemia
62 vs 19 episodes per 100 patient-years (P<0.001)
16 vs 5 episodes of coma or seizure per 100 patient-years
54 hospitalizations in 40 patients vs 36 hospitalizations in 27 patients to treat severe hypoglycemia

Funding

Supported by the Division of Diabetes, Endocrinology, and Metabolic Diseases of the National Institute of Diabetes and Digestive and Kidney Diseases and by the National Heart, Lung, and Blood Institute, the National Eye Institute, the National Center for Research Resources, and various corporate sponsors.

Sours: https://www.wikijournalclub.org/wiki/DCCT
What Is Kafkaesque? - The 'Philosophy' of Franz Kafka

Diabetes Control and Complications Trial (DCCT)

University of CaliforniaLa Jolla, California, United States, 92093-0620 Yale University School of MedicineNew Haven, Connecticut, United States, 06510 University of South Florida College of MedicineTampa, Florida, United States, 33612 Northwestern UniversityChicago, Illinois, United States, 60611 DCCT Central Autonomic Coding UnitSpringfield, Illinois, United States, 62702 University of IowaIowa City, Iowa, United States, 52242 University of MarylandBaltimore, Maryland, United States, 21201 George Washington University, Biostatistics CenterRockville, Maryland, United States, 20852 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Joslin Diabetes Center, Inc.Boston, Massachusetts, United States, 02215 University of Michigan, Sattelite-Henry Ford HospitalAnn Arbor, Michigan, United States, 48109-0832 Henry Ford HospitalDetroit, Michigan, United States, 48202 International Diabetes CenterMinneapolis, Minnesota, United States, 55416 DCCT Central Nutrition Coding UnitMinneapolis, Minnesota, United States, 55454-1015 DCCT Central ECG Reading UnitMinneapolis, Minnesota, United States, 55455-1015 DCCT Central Biochemistry LaboratoryMinneapolis, Minnesota, United States, 55455-9980 University of MinnesotaMinneapolis, Minnesota, United States, 55455 Mayo FoundationRochester, Minnesota, United States, 55905 Backup DCCT Central HbA1c LabColumbia, Missouri, United States, 65201 University of MissouriColumbia, Missouri, United States, 65212 Washington University at St. LouisSt. Louis, Missouri, United States, 63110 University of New Mexico School of MedicineAlbuquerque, New Mexico, United States, 87131 Albert Einstein College of MedicineBronx, New York, United States, 10461 Cornell University Medical College, The New York HospitalNew York, New York, United States, 10021 Case Western Reserve University, Lakeside HospitalCleveland, Ohio, United States, 44106 University of Pennsylvania, The Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania, United States, 19104 University of Pittsburgh, Children's HospitalPittsburgh, Pennsylvania, United States, 15213-3417 DCCT Central Neurobehavioral Coding UnitPittsburgh, Pennsylvania, United States, 15213 Medical University of South CarolinaCharleston, South Carolina, United States, 29403-5851 University of TennesseeMemphis, Tennessee, United States, 38163 Vanderbilt University, Diabetes Research and Training CenterNashville, Tennessee, United States, 37212 Vanderbilt UniversityNashville, Tennessee, United States, 37232-2230 University of TexasDallas, Texas, United States, 75235 University of WashingtonSeattle, Washington, United States, 98195 DCCT Central Ophthalmologic Reading Unit, Fundus Photo Reading CenterMadison, Wisconsin, United States, 53705-0240 University of Washington (British Columbia Satellite)Vancouver, British Columbia, Canada, V5Z 3N9 University of Western OntarioLondon, Ontario, Canada, N6A 5A5 University of Toronto, Mount Sinai HospitalToronto, Ontario, Canada, M5G 1X5
Sours: https://clinicaltrials.gov/ct2/show/NCT00360815

Summary dcct trial

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