Contents

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.

J Pediatr. 1994 Aug;125(2):177-88.
Full text | Metrics.

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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Updated on March 7th, 2022

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