Maternal Glycemic Control and Hypoglycemia in Type 1 Diabetic Pregnancy
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OBJECTIVE—To assess the safety and efficacy of insulin aspart (IAsp) versus regular human insulin (HI) in basal-bolus therapy with NPH insulin in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS—Subjects (n = 322) who were pregnant or planning pregnancy were randomized to IAsp or HI as meal-time insulin in an open-label, parallel-group, multicenter study. Subjects had A1C ≤8% at confirmation of pregnancy. Insulin doses were titrated toward predefined glucose targets and A1C <6.5%. Outcomes assessed included risk of major maternal hypoglycemia, A1C, plasma glucose profiles, and maternal safety outcomes. RESULTS—Major hypoglycemia occurred at a rate of 1.4 vs. 2.1 episodes/year exposure with IAsp and HI, respectively (relative risk 0.720 [95% CI 0.36–1.46]). Risk of major/major nocturnal hypoglycemia was 52% (RR 0.48 [0.20–1.143]; P = NS) lower with IAsp compared with HI. A1C was comparable with human insulin in second (IAsp-HI −0.04 [−0.18 to 0.11]) and third (−0.08 [−0.23 to 0.06]) trimesters. A total of 80% of subjects achieved an A1C ≤6.5%. At the end of first and third trimesters, average postprandial plasma glucose increments were significantly lower with IAsp than HI (P = 0.003 and P = 0.044, respectively), as were mean plasma glucose levels 90 min after breakfast (P = 0.044 and P = 0.001, respectively). Maternal safety profiles and pregnancy outcomes were similar between treatments. CONCLUSIONS—IAsp is at least as safe and effective as HI when used in basal-bolus therapy with NPH insulin in pregnant women with type 1 diabetes and may potentially offer some benefits in terms of postprandial glucose control and preventing severe hypoglycemia.
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Metformin or glyburide have not shown increased adverse pregnancy outcomes.
“oral agents such as metformin or glyburide have not shown increased adverse pregnancy outcomes and therefore can be considered.1430–1435”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1430]
The Treatments section describes insulin aspart and human insulin, not metformin or glyburide. The Pregnancy outcome section reports no significant difference between those insulin groups, but our copy does not address whether either oral agent increases adverse pregnancy outcomes (searched: metformin, glyburide, oral agents). (LLM, conf=0.78)
Experimental — accuracy not yet measuredRapid-acting insulin analogs are less likely than regular human insulin to cause hypoglycemia.
“Rapid-acting insulin analogs are likely more able than regular human insulin to help a woman achieve postprandial blood glucose targets and are less likely to cause hypoglycemia; fetal outcomes, however, seem comparable (28–30).”
From Diabetes and Pregnancy: An Endocrine Society Clinical Practice Guideline (2013) · cites this paper as [29]
Fetal outcomes with rapid-acting insulin analogs seem comparable to regular human insulin.
“Rapid-acting insulin analogs are likely more able than regular human insulin to help a woman achieve postprandial blood glucose targets and are less likely to cause hypoglycemia; fetal outcomes, however, seem comparable (28–30).”
From Diabetes and Pregnancy: An Endocrine Society Clinical Practice Guideline (2013) · cites this paper as [29]
Rapid-acting insulin analogs are likely more able than regular human insulin to help a woman achieve postprandial blood glucose targets.
“Rapid-acting insulin analogs are likely more able than regular human insulin to help a woman achieve postprandial blood glucose targets and are less likely to cause hypoglycemia; fetal outcomes, however, seem comparable (28–30).”
From Diabetes and Pregnancy: An Endocrine Society Clinical Practice Guideline (2013) · cites this paper as [29]
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- Authors
- Mathiesen, E. R., Kinsley, B., Amiel, S. A., Heller, S., McCance, D., Duran, S., Bellaire, S., Raben, A., & on behalf of the Insulin Aspart Pregnancy Study Group
- Affiliations
- Rigshospitalet (DK)
- Mater Misericordiae University Hospital (IE)
- King's College London (GB)
- Northern General Hospital (GB)
- Royal Victoria Hospital (GB)
- Unidad de Investigacion Diabetes, Hospital Virgen de Valme, Seville, Spain
- Novo Nordisk (Denmark) (DK)
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2007-04-01
- Volume
- 30
- Issue
- 4
- Pages
- 771-776
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2066807346
- Cited by
- 265
- References
- 40
- Citations by year
- 2026: 8 · 2025: 4 · 2024: 6 · 2023: 6 · 2022: 9 · 2021: 13 · 2020: 9 · 2019: 16 · 2018: 14 · 2017: 7 · 2016: 20 · 2015: 24 · 2014: 8 · 2013: 20 · 2012: 23
- FWCI
- 22.69
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Research Portal (King's College London) (submittedVersion)
- Funders
- Novo Nordisk
- Topics
- Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Keywords
- insulin aspart, regular insulin, type 1 diabetes in pregnancy, maternal hypoglycemia, multiple daily insulin injections, NPH insulin, glycemic control, HbA1c, postprandial blood glucose, nocturnal hypoglycemia, pregnancy outcomes
- MeSH terms
- Adult, Diabetes Mellitus, Type 1, Drug Administration Schedule, Europe, Female, Gestational Age, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin, Isophane, Pregnancy, Pregnancy Complications, Pregnancy Outcome, Quality of Life, Body Mass Index, Insulin Aspart
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