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)
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 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
- Health Information on Diabetes - The NIDDK offers information on many diabetes-related topics.
- 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
- As DCCT/EDIC looks to 35 years, researchers study effect of T1D on aging
- Fewer Exams Better Eye Health? Aye-aye, finds type 1 diabetes study
- Intensive blood glucose management for those with type 1 diabetes preserves heart health for decades
- Early tight blood glucose control reduces eye surgeries in people with type 1 diabetes
- Early blood glucose control lengthens life in people with type 1 diabetes
- Three decades later, diabetes study volunteers still find reward in participation
- Intensive therapy halves kidney disease in type 1 diabetes
- Celebrating 30 Years of Research Accomplishments of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study
- DCCT and EDIC 30th anniversary booklet (PDF, 4.26 MB)
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.