Premixed insulin aspart 30 (BIAsp 30) versus premixed human insulin 30 (BHI 30) in gestational diabetes mellitus: a randomized open-label controlled study.

A randomized, open-label, parallel study was conducted to assess the efficacy and safety of premixed insulin aspart 30 (biphasic insulin aspart [BIAsp] 30) in managing gestational diabetes mellitus (GDM). A total of 323 women with GDM registered at a single center in India were randomly assigned to receive 6 U of either BIAsp 30 (Group A) or premixed human insulin (biphasic human insulin [BHI] 30; Group B) in a 1:1 ratio. Subjects performed home glucose monitoring and visited their care provider twice a month. The primary outcome was the degree of neonatal macrosomia (neonatal birth weight >90th percentile). Groups A and B were demographically comparable at study entry. Before labor onset, Groups A and B achieved similar degrees of fasting plasma glucose and postprandial plasma glucose control (92.97 ± 14.44 vs. 95.43 ± 18.96 and 127.59 ± 28.99 vs. 126.98 ± 29.89, respectively; both p = NS). Neonatal macrosomia frequency was 6.3% in Group A and 6.9% in Group B; however, this difference was not statistically significant. By last visit, the required insulin dose was significantly lower for Group A than Group B (19.83 ± 15.75 IU vs. 26.34 ± 23.15 IU, respectively; p = 0.006). BIAsp 30 was noninferior to BHI 30, producing comparable fetal outcomes when administered during pregnancy. Based on final doses, BIAsp 30 may offer greater treat-to-target potential for pregnant women.

Point of care for gestational diabetes mellitus--a community-based study.

Universal screening for gestational diabetes mellitus (GDM) is advocated in Indian women as they have the highest frequency of GDM, among South Asian population. For this the diagnostic procedure has to be simple, economical and evidence based. Hence, this study was undertaken to compare the point-of-care measuring capillary blood glucose (CBG) by glucometer and venous plasma glucose (VPG) estimated in the laboratory and to suggest the feasible diagnostic tool. Consecutive pregnant women in the third trimester were included in this study with the approval of the institutional ethical committee. They were given 75 g oral glucose in the fasting state. After 2 hours, CBG was measured by finger-prick using one touch select simple glucometer and venous blood was drawn to estimate VPG in the laboratory by GOD- POD method. The diagnosis of GDM was based on 2 hours plasma glucose > or = 7.8 mmol/l. Among a cohort of 500 pregnant women, 32 (6.4%) were diagnosed as GDM in their first visit. The CBG value at 2 hours plasma glucose > or = 7.8 mmol/l had a sensitivity of 93.8% and specificity of 97.4% with a false positive and false negative of 2.6% and 6.2%, respectively. The area under the receiver operating characteristic curve of CBG was 0.993. CBG value at 2 hours plasma glucose > or = 7.8 mmol/l may be recommended for the diagnosis of GDM in healthcare centres where laboratory technology is not available.