The medical history (age, gender, duration of diabetes) was collected from each subject. The subjects continued to receive the PHI70/30 regimen during the 2-week lead-in period, and were then randomly divided into two treatment arms: one arm received the LM25 regimen and the other arm received the LM50 regimen during the first 16-week treatment period, and the two arms then switched regimens for the next 16-week treatment period. The first four weeks of each 16-week treatment phase were the insulin dose titration period, when the patients were asked to self-monitor their blood glucose levels and insulin dose adjustments were made based on their results (the adjustment protocol is shown in Table 1). The next 12 weeks were the steady dose period. Oral hypoglycemic agents were not adjusted throughout the entire period of the study. The targets for glycemic control were blood glucose levels before breakfast and dinner of > 3.9 and ≤ 6.1 mmol/L, respectively.

Insulin sliding scale

Blood glucose (mmol/L)Insulin dose adjustment
≤ 3.9− 1 ~ 2 U
> 3.9 and ≤ 6.1Unchanged
> 6.1 and ≤ 7.8+ 1 ~ 2 U
> 7.8+ 2 ~ 4U
During the study, the subjects were assigned diets recommended by nutritionists based on the 2013 China Medical Nutrition Therapy Guidelines for Diabetes [14 ]. The diets led to 45–60% of the total daily energy being derived from carbohydrates, 25–35% from dietary fat, and 15–25% from protein. The total daily energy intake was calculated based on the height and weight of each subject. Subjects were also required to exercise regularly during the study. During the 3 days of CGM at the end of each treatment phase, the subjects were given high-carbohydrate test meals (with 56.8–58.4% of the total energy deriving from carbohydrate, 15.7–17.2% from protein, and 24.4–26.7% from fat) on day 1 and high-fat test meals (with 39.8–40.7% of the total energy deriving from carbohydrate, 23.0–24.4% from protein, and 33.0–36.1% from fat) on day 2. They continued their habitual diets in day 3.
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