In order to test clinically a newly developed, simple, and convenient device for giving multiple injections of short-acting insulin (Actrapid HM, Novo, Bagsvaerd, Denmark), 16 type I diabetic patients previously stabilized on intensified conventional therapy regimens participated in a randomized crossover study for a period of 6 wk. The patients used conventional syringes for injections of short-acting insulin during one period and the new device during the other. Conventional syringes were used for injections of basal insulin during both periods. Metabolic control was assessed by twice-weekly blood glucose profiles, HbA1c, and the frequency of hypoglycemic reactions; no significant differences were found during the two treatment periods. No infections at the injection sites were seen. Patients' evaluation of the new device was very positive.
The clinical acceptability and the influence on diabetes control were investigated in 50 women with insulin-dependent diabetes mellitus (IDDM) during intake of a combined nonalkylated estrogen/progestogen compound (4 mg 17-beta estradiol, 2 mg estriol and 1 mg norethindrone) for one year. In 6 IDDM women, the influence of the hormonal treatment on diabetes control and on ovarian function was investigated by measuring the concentration of glycosylated hemoglobin (Hb-Alc), fasting plasma glucose, serum estradiol, serum estrone, serum progesterone and sex hormone binding globulin (SHBG) capacity. No pregnancy occurred during the study and the overall continuation rate of 60% compare well with the continuation rate normally found in non-diabetic women after administration of conventional type oral contraceptives. No difficulties with diabetes control was registered and no significant changes in insulin requirements, 24-h urinary glucose excretion nd Hb-Alc were found. Ovulation was inhibited during the hormonal intake as judged by serum progesterone measurements. Serum estrone increased (p less than 0.05), but this had no influence on SHBG capacity, indicating that the estrogen/androgen balance was unchanged during treatment.
A longitudinal study was carried out of all patients with newly acquired insulin dependent diabetes during pregnancy (as distinct from non-insulin-dependent gestational diabetes) seen at the Copenhagen Centre for Diabetes and Pregnancy during 1966 to 1980. The series comprised 63 patients with a mean age of 27 (SEM 1) years. At diagnosis the mean fasting blood glucose concentration was 15.6 (1.3) mmol/l and mean maximal insulin dose 49 (3) IU/day. At a prospective follow up examination a mean of 8 (SEM 1) years after diagnosis 46 of 60 patients (77%) were being treated with insulin (35 (2) IU/day) and had a very low mean stimulated plasma C peptide value (0.12 (0.02) nmol/l) suggesting absent or nearly absent beta cell function. The remaining 14 patients (23%), not currently receiving insulin, appeared to be severely glucose intolerant, having a mean fasting blood glucose concentration of 13.4 (1.2) mmol/l. Thus most of these patients developing insulin dependent diabetes during pregnancy had true type I disease. Compared with the age specific incidence of type I diabetes in the background population of women the incidence was at least 70% higher in pregnant than non-pregnant women (p less than 0.001; chi 2 = 11.6; f = 1). This increased incidence occurred in the third trimester when the risk of developing type I diabetes was 3.8 times that of non-pregnant women (p less than 0.000001; chi 2 = 35.6; f = 1). Finally, the risk of developing insulin dependent diabetes during pregnancy was lower when conception occurred in the winter (p less than 0.05; chi 2 = 4.18; f = 1).
55 children who were in utero when type 1 diabetes developed in their mothers were studied at a mean (SEM) age of 10.4 (0.6) years: only 1 was diabetic. Biochemical and immunological indices, measured in 35 children, showed no evidence of beta cell dysfunction. Thus, the fetal beta cells seem to be unaffected by the mechanisms that cause diabetes in their mothers.
A screening system for detection of diabetes in pregnancy was carried out in a geographically well-defined unselected population of 2 457 pregnant women all living in the community of Copenhagen. The screening was based on clinical criteria for potential diabetes consisting of previous delivery of a large baby, a family history of diabetes and obesity combined with examination of glucosuria and determination of the fasting blood glucose concentration. It was possible to follow up 95% of all pregnancies. One hundred and ninety women had a positive screening determination and among these women, 24 (1%) were found to have diabetes in pregnancy. It was established that a fasting blood glucose concentration of 4.1 mmol/l was the ideal cut-off point for referring potential diabetics to an oral glucose tolerance test (OGTT). The screening procedure is easy to administer and acceptable for the pregnant woman. The screening OGTT should be performed in the second or third trimester as only one woman had diabetes detected in the first trimester in this study.
The study concerns the clinical outcome and later prognosis (regarding permanent insulin treatment) of patients who develop insulin-dependent diabetes mellitus during pregnancy (which is different from gestational diabetes). Sixty-three such patients (27 +/- 1 (SEM) years old) were delivered at the Copenhagen Centre for Diabetes and Pregnancy during the years 1966-1980. Obstetric complications such as toxaemia were seen in 9.5% of these study patients and the perinatal mortality was 6.3%, both percentages being higher than in the general population (1.1%, p less than 10(-7) and 1.0%, p less than 10(-3), respectively), but similar to those observed in patients with Type 1 diabetes diagnosed before pregnancy. In contrast, the frequency of malformations was 1.6%, the same as in the general population (1.4%), but lower than that seen in patients with long-standing diabetes (8.3%, p less than 0.05). At follow-up examination 8 +/- 1 years after diagnosis all patients were diabetic; 77% were insulin treated, having no or virtually no residual B-cell function, and were clearly Type 1 diabetic patients. After delivery 80% of the patients had a remission period (median 256 days) without insulin treatment. This remission period was absent or shortest in patients with the following characteristics (p less than or equal to 0.03): low age, first parity, not overweight, and high blood glucose level at diagnosis. These prognostic parameters should be considered in obligatory, clinical follow-up plans for such patients.