DCCT - Hypoglycemia

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  • Group characteristics:Slighlty more menAvarage age 26 – 27Mainly caucasianMinority ovewightNo significant differences in stimulated C-paptide, HBA1c at eligibility screening, insulin dosage
  • There were 3,788 episodes of severe hypoglycemia (requiring assistance); 1,027 of these episodes were associated with coma and/or seizure.The overall rates of severe hypoglycemia were 61.2 per 100 patient-years vs. 18.7 per 100 patient-years in the intensive and conventional treatment groups, respec­tively, with a relative risk (RR) of 3.28. The relative risk for coma and/or seizure was 3.02 for intensive therapy.When baseline patient charac­teristics were examined for effects on the risk of severe hypoglycemia, the relative risk of hypoglycemia for intensive versus conventional treatment was >2 for all subgroups. Several subgroups defined by baseline characteristics, including males, adolescents, and sub­jects with no residual C-peptide or with a prior history of hypoglycemia, had a particularly high risk of severe hypoglycemia in both treatment groups.
  • 65% of patients in the intensive group vs. 35% of patients in the conventional group ≥1 episode of severe hypoglycemia by the study end. Cumulative incidence of successive episodes indi­cated that intensive treatment was also associated with an increased risk of multiple episodes within the same patient (e.g., 22% experienced five or more episodes of severe hypoglycemia within the first 5 years of follow- up vs. 4% in the conventional group). Within both treatment groups, patients who experienced severe hypoglycemia were at increased risk of subsequent episodes. Approximately 30% of patients in each group experienced a second episode within the 4 months fol­lowing the first episode of severe hypoglycemia.
  • DCCT - Hypoglycemia

    1. 1. Hypoglycemia in the diabetes control and complications trial The Diabetes Control and Complications Trial Research Group Diabetes (1997) Diabetes and Endocrine Study Day 2013/12/19 Buckfast Abbey Conference Centre Andrzej Rys
    2. 2. Patients/Population • • • multicentre, randomized clinical trial, 26 clinics across the U.S. + 3 in Canada patients with IDDM from 1983 to 1989 and followed them until 1993. 1,441 patients randomly assigned to receive intensive (n = 711)/con-ventional (n = 730) Rx
    3. 3. Intervention Clinical goals for both groups - avoidance of symptoms of hyperglycaemia and hypoglycaemia. Conventional Intensive  R/V by health care team 1x  hospitalized to initiate therapy every 3 months,  seen at least monthly thereafter by the  one or two insulin injections per health care team# day,  additional specific targets:  monitor either urine or blood • Pre-prandial 70-120 mg/dl (3.9-6.67 mmol/l) glucose without specific numeric • Post-prandial <180 mg/dl (<10 mmol/l) glucose targets, • 03:00 am (tested 1x/week) >65 mg/dl (>3.61 mmol/l)  Choice of either: • • MDI regimen continuous subcutaneous insulin infusion with an external pump
    4. 4. Comparison (1) Conventional (n = 730) Intensive (n = 711) Percentage of patients with an event Percentage of patients with an event At study end Cumulative at 9 years Number of Rate At study end Cumulative at Number 9 years of Rate Relativ e risk 95% Cl Hypoglycaemi c events 34.9 41.3 892 18.7 64.6 72.8 2,896 61.2 3.285 (2.65,4.05) Coma and/or seizure 18.8 25.5 257 5.4 38.1 47.4 770 16.3 3.02 (2.36,3.86) Hypoglycaemia risk CONVENTIONAL Percentage Number of n INTENSIVE Percentage Number of with event events Rate n with event events Rate RR 95% CI Sex Male 395 33.9 373 14.63 366 66.4 1,535 63.59 4.35 3.20-5.90 Feniale 335 36.1 519 23.31 345 62.6 1,361 58.69 2.52 1.87-3.38 Adolesce 103 nt 44.7 207 27.80 92 81.5 603 85.74 3.08 1.97-4.84 Adult 33.3 685 16.99 619 62.0 2,293 56.90 3.35 2.63-4.26 AGE 627
    5. 5. Comparison (2) CONVENTIONAL Percentage Number of n with event INTENSIVE Percentage Number of events Rate n with event events Rate RR 95% CI Stimulated C-peptide (pmol/ml) <0.20 565 37.5 787 20.79 572 68.5 2,598 66.94 3.22 2.56-4.05 >0.20 165 26.1 105 10.61 139 48.2 298 34.99 3.30 1.94-5.62 IDDM duration (years) <6 469 30.1 457 15.64* 436 61.0 1,522 54.87 3.51 2.5.5-4.83 6-10 128 48.4 232 25.91 119 67.2 574 67.00 2.59 1.74-3.84 >10 133 39.1 203 21.19 156 72.4 800 72.56 3.42 2.33-5.04 HbA1c at eligibility screening (%) <7.825 189 45.0 327 27.22 171 59.1 607 56.93 2.09 1..37-3.19 7.82.5- 8.819 185 38.9 232 18.82 175 67.4 682 58.65 3.12 2.15-4.51 8.820- 10.099 166 30.7 176 16.07 192 68.8 898 66.39 4.13 2.79-6.13 10.100+ 190 24.7 157 12.60 173 62.4 709 61.59 4.89 3.05-7.83 <0.635 373 27.6 290 12.41 345 55.9 1,090 49.26 3.97 2.73-5.76 >0.635 357 42.6 602 24.68 366 72.7 1,806 71.66 2.90 2.25-3.75 Insulin (U/kg)
    6. 6. Outcomes • Hypoglycemia - the most frequent adverse effect of intensive therapy of IDDM • DCCT rate of hypoglycaemic episodes (16.3 per 100 patient-years in the intensive therapy group) and episodes of loss of consciousness (11%) were in the range reported elsewhere • 65% of patients in the intensive group vs. 35% of patients in the conventional group ≥1 episode of severe hypoglycemia by the study end • Intensive treatment - increased risk of multiple episodes within the same patient (e.g., 22% ≥ 5 episodes of severe hypoglycemia within the first 5 years of follow- up vs. 4% in the conventional group) • Both treatment groups - increased risk of subsequent episodes after 1st episode • Both treatment groups - ~ 30% experienced a 2nd episode within the 4 months fol-lowing the 1st episode

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