Objective. To document that strict dietary regimen are not necessary i
n the context of intensified insulin therapy. Design. German multicent
re, prospective cohort study; 6 years follow-up. Setting. Ambulatory e
xamination using a mobile ambulance. Subjects, A total of 636 type 1 d
iabetic patients (age 33+/-7 years, diabetes duration 15+/-7 years; me
an+/-SD), who had participated in a structured, 5-day, in-patient, gro
up treatment and teaching programme for intensification of insulin the
rapy and liberalization of the diabetes diet 6 years prior to follow-u
p. Main outcome measures. Relations between the extent to which patien
ts practise a liberalized diet, the degree of metabolic control (HbAlc
, severe hypoglycaemia, body mass index, cholesterol), and the patient
s' perceived burden through dietary treatment. Results. In the total p
atient group, HbAlc was 7.9+/-1.6%, and the incidence of severe hypogl
ycaemia was 0.17 cases per patient during the preceding year; 31% pati
ents injected insulin less than or equal to 3 times per day, 58% 4-7 t
imes per day, and 11% used insulin pump therapy. Only 11% patients rep
orted following a meal plan, whereas 89% continually changed timing an
d amount of carbohydrate intake; only 5% had the same number of meals
every day, whereas as many as 20% varied the number of meals per day b
y four or more; 53% skipped main meals; 85% habitually consumed sugar
or sugar containing foods. Patients with a higher degree of diet liber
alization injected insulin or used an insulin pump therapy more freque
ntly, and perceived their dietary treatment to be less burdensome. No
clinically significant associations were found between the extent of d
iet liberalization and metabolic control. Conclusions. Under the condi
tions where type 1 diabetic patients have the opportunity to participa
te in an intensified insulin treatment and teaching programme, liberal
ization of the diabetes diet is not associated with adverse effects on
glycaemic control, but is associated with less perceived burden throu
gh dietary treatment.