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Diabetes Control and Complications Trial (DCCT)
July, 1998
Clinical trial
Early worsening of diabetic retinopathy in the Diabetes Control and Complications Trial.
Arch Ophthalmol. 1998 Jul;116(7):874-86.
Full text
Main finding: Early worsening of retinopathy can occur with intensive treatment in patients with long-standing poor glycemic control, particularly if retinopathy is at or past the moderate nonproliferative stage.
- Purpose: To examine whether intensive blood glucose control could decrease the frequency and severity of long-term microvascular and neurologic complications in patients with insulin-dependent diabetes mellitus
- Study type: Randomized controlled trial
- Condition: Diabetes Mellitus
Participants: 13-39yo, insulin-dependent DM
- n=1441
Intervention:
Group 1: No retinopathy at baseline (Primary prevention cohort)
Group 2: Mild retinopathy at baseline (Secondary intervention cohort)
Each group were then randomised to:
Intervention 1: Intensive therapy: external insulin pump or ≥daily insulin injections + frequent BSL monitoring
Intervention 2: Conventional therapy: 1-2 daily insulin injections
Early worsening was observed at the 6- and/or 12-month visit in 13.1% of patients who had intensive treatment and in 7.6% who had conventional treatment.
August, 1995
Clinical trial
The relationship of glycemic exposure (HbA1c) to the risk of development and progression of retinopathy in the diabetes control and complications trial.
Diabetes. 1995 Aug;44(8):968-83.
Full text
Main finding: Mean HbA1c during the DCCT was the dominant predictor of retinopathy progression.
- Purpose: To examine whether intensive blood glucose control could decrease the frequency and severity of long-term microvascular and neurologic complications in patients with insulin-dependent diabetes mellitus
- Study type: Randomized controlled trial
- Condition: Diabetes Mellitus
Participants: 13-39yo, insulin-dependent DM
n=1441
Intervention:
Group 1: No retinopathy at baseline (Primary prevention cohort)
Group 2: Mild retinopathy at baseline (Secondary intervention cohort)
Each group were then randomised to:
Intervention 1: Intensive therapy: external insulin pump or ≥daily insulin injections + frequent BSL monitoring
Intervention 2: Conventional therapy: 1-2 daily insulin injections
Mean HbA1c during the DCCT was the dominant predictor of retinopathy progression
- A 10% lower HbA1c is associated with a 43% lower risk in the intensive group and a 45% lower risk in the conventional group.
Glycaemic exposure pre-DCCT (screening HbA1c value and IDDM duration) and glycemic exposure during the DCCT (mean HbA1c, time in study, and their interaction) were significantly associated with risk of retinopathy progression
August 1, 1994
Clinical trial
Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial.
Main finding: Intensive control effectively delays the onset and slows the progression of diabetic retinopathy.
- Purpose: To examine whether intensive blood glucose control could decrease the frequency and severity of long-term microvascular and neurologic complications in patients with insulin-dependent diabetes mellitus
- Study type: Randomized controlled trial
- Condition: Diabetes Mellitus
Participants: 13-39yo, insulin-dependent DM
- n=1441
Intervention:
Group 1: No retinopathy at baseline (Primary prevention cohort)
Group 2: Mild retinopathy at baseline (Secondary intervention cohort)
Each group were then randomised to:
Intervention 1: Intensive therapy: external insulin pump or ≥daily insulin injections + frequent BSL monitoring
Intervention 2: Conventional therapy: 1-2 daily insulin injections
Adolescent subgroup of 13-17yo:
Primary prevention cohort: intensive therapy decreased the risk of having retinopathy by 53% vs conventional therapy.
Secondary-intervention cohort: Intensive therapy decreased the risk of retinopathy progression by 70%.
September 30, 1993
Clinical trial
The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus.
Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C.
N Engl J Med. 1993 Sep 30;329(14):977-86.
Full text
Main finding: Intensive control effectively delays the onset and slows the progression of diabetic retinopathy.
- Purpose: To examine whether intensive blood glucose control could decrease the frequency and severity of long-term microvascular and neurologic complications in patients with insulin-dependent diabetes mellitus
- Study type: Randomized controlled trial
- Condition: Diabetes Mellitus
Participants: 13-39yo, insulin-dependent DM
- n=1441
Intervention:
Group 1: No retinopathy at baseline (Primary prevention cohort)
Group 2: Mild retinopathy at baseline (Secondary intervention cohort)
Each group were then randomised to:
Intervention 1: Intensive therapy: external insulin pump or ≥daily insulin injections + frequent BSL monitoring
Intervention 2: Conventional therapy: 1-2 daily insulin injections
Primary prevention cohort: Intensive therapy reduced mean risk of developing retinopathy by 76% vs conventional therapy.
Secondary-intervention cohort: Intensive therapy slowed progression of retinopathy by 54%, and reduced development of proliferative or severe nonproliferative retinopathy by 47%.
The main adverse event for intensive control was a 2-3x increased risk of severe hypoglycaemia.
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