**3. Randomised cross-over clinical trial on metabolic effectiveness and feasibility of three intensive insulin regimens with particular consideration of night period in PWD 1 (Institute of Diabetes Karlsburg, Germany, 1989–1990)**

**Subjects:** A group of 36 T1D (males, age 18 to 50 years, duration of diabetes at least 3 years, C-peptide 0,037 0,013 nmol/l, BMI 23,6 0,5 kg/m<sup>2</sup> , PWC 170 172,5 6,8 W, retinopathy 1st grade in 7 and 2nd grade in 7 of them, traces of proteinuria in 11 of them, proteinuria > 2 g/d in one of them) completed the study.

*Intensive Management of Type 1 Diabetes in Adults: One Centre Experience 1970–2022 DOI: http://dx.doi.org/10.5772/intechopen.108032*

### **Figure 7.**

*Abstract book Symposium on Diabetes and exercise, 21.-23.1.1982, Olomouc, Czechoslovakia, organised by Palacký University Olomouc and Central Institute of Diabetes G. Katsch Karlsburg; Olomouc, 1982 p 102 [63, 91–96].*

**Study design:** The suggested protocol considered our previous experience and outcomes of other studies on dawn phenomena and pharmacokinetics of various insulin preparations [97–105]. After admission, each of the three insulin regimens A, B, and C (**Tables 1** and **2**) was randomly tested over two weeks and then replaced by another one. At discharge (6 weeks after admission) the tested person could choose the preferred regimen for the 8-week treatment period at home/at work. Final inpatient examination targeted to the complex assessment of respective clinical and laboratory parameters.

**Results:** The basal and prandial insulin substitution with only purified porcine shortacting insulin (SNC, Berlin Chemie) given seven times a day (regimen A) was the most effective kind of the conventional insulin therapy as assessed by the mean cBG (MBG 16) of 16-point BG profiles at the end of the respective test period (**Figure 8**).

The regimen A led to the best metabolic control in 21/36 (58%) of patients (**Figures 9** and **10**).

The insulin regimen B with one animal intermediate insulin preparation (BS, Berlin Chemie) at 10 p.m. or the regimen C with a long-acting insulin (Ultratard HM, NovoNordisk) at 5.30 p.m. led to the best control in 6/36 (17 %) or in 9/36 (25%) of all patients, respectively.

