Characteristic Study ID
|
Intensive glucose control
[route, frequency, total dose/day] |
Conventional glucose control
[route, frequency, total dose/day] |
Bucharest‐Düsseldorf 1984 |
Glycaemic targets: preprandial: as normal as possible (˜ 5.5 mmol/L / 99 mg/dL)
5 day patient training at beginning of study
At least two insulin injections per day of mixed intermediate and rapid insulin preparations
3‐4 times daily preprandial and bedtime self‐monitoring of blood glucose or urine glucose concentrations
Self‐adaptation of insulin dosages to reach optimal glycaemic control
|
Glycaemic targets: aglucosuria without significant hypoglycaemic episodes
4 day patient training at the beginning of the study
Twice daily injection of intermediate acting insulin or a combination of intermediate and rapid acting insulin
Self‐monitoring of glucosuria and acetonuria
Self‐adjustment of insulin dosages
|
DCCT 1&2 (primary prevention and secondary intervention) 1993 |
Glycaemic targets: HbA1c < 6.05%
Preprandial: 3.9‐6.7 mmol/L (70‐120 mg/dL); postprandial: < 10 mmol/L (180 mg/dL); 3 am: > 3.6 mmol/L (65 mg/dL)
Administration of insulin three time or more per day by injection or pump, adjustment of insulin dose according to results of self‐monitored blood glucose
|
No specific glycaemic targets
Goals: absence of symptoms attributable to glycosuria or hyperglycaemia, absence of ketonuria, normal growth & development, ideal body weight, freedom from severe or frequent hypoglycaemia
One or two daily injections of insulin (including mixed intermediate and rapid‐acting insulins), daily self‐monitoring of urine or blood glucose
|
Holman 1983 |
Glycaemic targets: preprandial 4 ‐ 7 mmol/L (72‐126 mg/dL)
Treated more intensively
Dietary advice to maintain ideal body‐weight and optimise control
Patients were taught home blood glucose monitoring and encouraged to test four times/day
|
|
MCSG 1995 |
Glycaemic targets: HbA1c: ≤ 7.5%
Fasting glucose: 4 ‐ 6 mmol/L (72‐108 mg/dL); two hour postprandial: ≤ 10 mmol/L (180 mg/dL)
Continuous subcutaneous infusion or multiple daily injections regular seven point blood glucose profiles and adjustment of treatment regimen in consultation with the investigation team
|
No glycaemic targets
Two daily injections of insulin, including intermediate and short acting insulin
Conventional education about diet, exercise, and self‐monitoring of blood glucose values was given but targets were not set
|
MDCCT 1994 |
Glycaemic targets: HbA1c < 7.0%
Preprandial 3.3 – 8.3 mmol/L (60‐150 mg/dL); 1h postprandial < 10 mmol/L (180 mg/dL)
Urine free of glucose
Insulin injections several times a day (usually a mixture of beef/pork isophane insulin and crystalline regular insulin before breakfast, crystalline regular insulin before supper, and isophane insulin at bedtimed) or subcutaneous continuous insulin infusion
|
Glycaemic targetsa: HbA1c < 14.0%
No more than 60% of home glucose measurements > 11.1 mmol/L (200 mg/dL), and no more than 20% of measurements > 16.7 mmol/L (300 mg/dL),
24h urine < 50g glucose
Subcutaneous insulin given once or twice each day
One daily injection of a mixture of isophane insulin and crystalline regular insulin (100 U/mL, beef/pork) 30 minutes before breakfastb,c
|
Linn 1996 |
Glycaemic targets: HbA1c < 6.5%
Preprandial < 6.8 mmol/L (122 mg/dL)
Postprandial < 10 mmol/L (180 mg/dL)
Administration of insulin at least three times daily by injection; dosage adjusted by the patients or by health care professionals according to the results of self‐monitoring of blood glucose, dietary intake, and anticipated exercise
|
Glycaemic targets: absence of symptoms attributable to glucosuria or hyperglycaemia, and freedom from severe or frequent hypoglycaemia
One or two daily injections of insulin, including mixed intermediate and rapid‐acting insulins and variable self‐monitoring of blood glucose
Not always daily adjustments in the insulin dosage
|
Oslo 1987 |
Glycaemic targets: preprandial: 3‐5 mmol/L (54‐90 mg/dL); postprandial (90min): 5‐10 mmol/L (90‐180 mg/dL)
Absence of symptomatic hypoglycaemia
Continuous insulin infusion by insulin pump
˜ 50% of the daily insulin dose injected continuously, the rest as bolus insulin 15 minutes before meals
Multiple injections: NPH at bedtime, regular porcine insulin 15‐30 minutes before each meal (4‐6 times daily)
|
|
Steno 1 1983 |
Glycaemic targets: postprandial < 9 mmol/L (162 mg/dL), no glucosuria
Continuous subcutaneous insulin infusion (CSII): using the portable Mill Hill 1001HM
|
Glycaemic targets: postprandial morning blood glucose < 15 mmol/L (270 mg/dL); 24 urinary glucose excretion < 20g, no ketonuria, no hypoglycaemic episodes
Two daily injections of mixtures of intermediate‐ and short‐acting insulin
|
Steno 2 1986 |
Glycaemic targets: fasting: 4‐7 mmol/L (70‐130 mg/dL); postprandial: 5‐10 mmol/L (90‐180 mg/dL) while avoiding blood glucose level < 3 mmol/L (54 mg/dL)
Short‐acting insulin infusion at basal rates with bolus injections
|
|
Wysocki 2003
4 |
Glycaemic targets: HbA1c ≤ 6.5%
Preprandial: 3.9 ‐ 6.7 mmol/L (70 – 120 mg/dL); postprandial: < 8.3 mmol/L (150 mg/dL); 3 am blood glucose: > 3.6 mmol/L (65 mg/dL)
At least three daily insulin injections or use of an insulin pump
At least four blood glucose tests daily
Weekly telephone contact initiated by diabetes nurse, services as needed from dietitian and psychologist, monthly visits with diabetes nurse, quarterly visits with endocrinologist; advanced diabetes education; optional: monthly support group
|
Glycaemic targets: HbA1c ≤ 8.0%
Preprandial: 3.9 ‐ 7.8 mmol/L (70‐140 mg/dL); postprandial: < 10 mmol/L (180 mg/dL); 3 am blood glucose > 3.6 mmol/L (65 mg/dL)
2‐3 daily insulin injections
3‐4 daily glucose tests
Quarterly visits with endocrinologist, diabetes nurse, systematic diabetes education; annual visit with dietitian and psychologist
|
Verrillo 1988 |
Glycaemic targets: fasting: 4‐8 mmol/L (72‐144 mg/dL); 2h‐postprandial: < 10 mmol/L (180 mg/dL) while avoiding < 3 mmol/L (54 mg/dL)
Insulin administration three times daily (long‐acting insulin in the morning, short‐acting insulin 15‐30 minutes before lunch and dinner)
Clinic visits every 4 weeks for the first year, and every 8 weeks for the other years
|
Glycaemic targets: preprandial (morning) < 12 mmol/L (216 mg/dL); 24‐h urinary glucose excretion: < 20 g
Less than twice daily insulin injections of intermediate‐acting insulin, often mixed with short‐acting insulin
Routine diabetic clinic visits
|
Footnotes "‐" denotes not reported aSince 1980 the aim was to avoid HbA1c values ≥ 12% bApproximately one third of the patients were treated with two injections of a mixture of isophane insulin and crystalline regular insulin daily for extended periods to improve glycaemic control cDuring the last five years of the study most patients switched to an insulin regimen using human insulin dGlycaemic targets were relaxed for children who experienced ≥ 2 severe hypoglycaemic episodes within 6 months HbA1c: glycated haemoglobin concentration; NPH: neutral protamine Hagedorn |