Effect of a levonorgestrel intrauterine system on women with type 1 diabetes: A randomized trial
Rogovskaya,Svetlana; Rivera,Roberto; Grimes,David A.; Chen,Pai-lien; Pierre-Louis,Bosny; Prilepskaya,Vera; Kulakov,Vladimir
Obstetrics and Gynecology 105(4): 811-815
Publication date: 2005
Summary: Levonorgestrel Intrauterine System Safe for Women with Type I Diabetes
A recent study by Family Health International and the Russian Academy of Medical Science reports that women with type 1 diabetes (also known as juvenile or insulin-dependent diabetes) can safely use the levonorgestrel-releasing intrauterine system (LNG-IUS). This finding will be submitted to the World Health Organization (WHO) to encourage a revision of its widely used Medical Eligibility Criteria for Contraceptive Use, which currently states-cautiously-that the benefits of LNG-IUS use by women with diabetes generally outweigh the risks. Based in part on the new evidence, the authors of the study believe the WHO recommendation for the LNG-IUS should be changed to no restrictions on use among women with diabetes. This would then match the current recommendation for use of the nonhormonal intrauterine device (IUD) by this same population. In the study, 62 women with uncomplicated type 1 diabetes were randomly assigned to use either an LNG-IUS or a copper IUD for 12 months. Throughout that period, no important differences were found in glycosylated hemoglobin levels, fasting serum-glucose levels, or daily insulin requirements between the groups.
Women with diabetes need safe, effective contraception. Although intrauterine devices provide superior contraception, concerns remain that progestin absorbed systemically from the levonorgestrel-releasing device may impair carbohydrate metabolism. To examine the effect of the levonorgestrel-releasing intrauterine system on glucose metabolism in diabetic women.
We randomly assigned 62 women with uncomplicated insulin-dependent diabetes mellitus to either a levonorgestrel-releasing or a copper T 380A intrauterine device. The primary outcome to assess glucose metabolism was glycosylated hemoglobin; fasting serum-glucose levels and daily insulin dose requirements over 12 months of observation were examined as well.
Outcome data were available for 29 women using the levonorgestrel-releasing and 30 using the copper device. At 12 months, mean glycosylated levels were similar for women of the 2 groups (6.3%, standard deviation [SD] ± 1.5 compared with 6.3%, SD ± 1.3, respectively). The same was true for mean fasting-serum glucose levels (7.4 mM, SD ± 4.2 compared with 7.5 mM, SD ± 4.2) and daily insulin doses (35.1 units, SD ± 12.8 compared with 36.4 units, SD ± 9.0). No important differences were noted at either 6 weeks or 6 months.
The levonorgestrel-releasing device had no adverse effect on glucose metabolism, even at the 6-week observation when systemic levels of levonorgestrel would have been higher than at later observations. Concern about a potential adverse effect of this contraceptive on glucose control is unwarranted, and its use in women with diabetes should be liberalized.
Level of Evidence