Table 3.

Endpoints in the study.

Primary endpoint
Difference in mean blood glucose level between the two diet periods1
Secondary endpoints
The difference in standard deviation of blood glucose levels between the two diet periods1
The difference in time above range between the two diet periods (above 10.0 mmol/l and above 13.9 mmol/l respectively) 1
The difference in time in range (5.5–10.0 mmol/l and 3.9–10.0 mmol/l respectively) between the two diet periods1
The difference in weight between the two diet periods
The difference in total cholesterol between the two diet periods
The difference in LDL cholesterol between the two diet periods
The difference in HDL cholesterol between the two diet periods
The difference in triglycerides between the two diet periods
The difference in total insulin dose between the two diet periods
The difference in DTSQc score at the end of the study between the two diet periods
The difference in DTSQs scores between the two diet periods
The difference in hypoglycemia confidence scores between the two diet periods
Other exploratory endpoints
The difference in MAGE between the two diet periods1
The difference in HbA1c between the two diet periods
The difference in apolipoproteins between the two diet periods
Safety endpoints
The difference in the proportion of time with low blood glucose levels between the two diet periods (below 3.0 mmol/l and below 3.9 mmol/l respectively)1
The difference in the mean number of severe hypoglycemic events between the two diet periods defined as unconsciousness due to hypoglycemia or requiring assistance from another person
The difference in ketone levels between the two diet periods
Occurrence of ketoacidosis during the study period and differences between the two diet periods

¹Measured with continuous glucose monitoring during the last 2 weeks of interventions.