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Meta-Analysis
. 2017 Nov 5;11(11):CD012037.
doi: 10.1002/14651858.CD012037.pub2.

Insulin for the treatment of women with gestational diabetes

Julie Brown  1 , Luke Grzeskowiak, Kathryn Williamson, Michelle R Downie, Caroline A Crowther
Affiliations
Meta-Analysis

Insulin for the treatment of women with gestational diabetes

Julie Brown et al. Cochrane Database Syst Rev. .

Abstract

Background: Gestational diabetes mellitus (GDM) is associated with short- and long-term complications for the mother and her infant. Women who are unable to maintain their blood glucose concentration within pre-specified treatment targets with diet and lifestyle interventions will require anti-diabetic pharmacological therapies. This review explores the safety and effectiveness of insulin compared with oral anti-diabetic pharmacological therapies, non-pharmacological interventions and insulin regimens.

Objectives: To evaluate the effects of insulin in treating women with gestational diabetes.

Search methods: We searched Pregnancy and Childbirth's Trials Register (1 May 2017), ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP) (1 May 2017) and reference lists of retrieved studies.

Selection criteria: We included randomised controlled trials (including those published in abstract form) comparing:a) insulin with an oral anti-diabetic pharmacological therapy;b) with a non-pharmacological intervention;c) different insulin analogues;d) different insulin regimens for treating women with diagnosed with GDM.We excluded quasi-randomised and trials including women with pre-existing type 1 or type 2 diabetes. Cross-over trials were not eligible for inclusion.

Data collection and analysis: Two review authors independently assessed study eligibility, risk of bias, and extracted data. Data were checked for accuracy.

Main results: We included 53 relevant studies (103 publications), reporting data for 7381 women. Forty-six of these studies reported data for 6435 infants but our analyses were based on fewer number of studies/participants.Overall, the risk of bias was unclear; 40 of the 53 included trials were not blinded. Overall, the quality of the evidence ranged from moderate to very low quality. The primary reasons for downgrading evidence were imprecision, risk of bias and inconsistency. We report the results for our maternal and infant GRADE outcomes for the main comparison. Insulin versus oral anti-diabetic pharmacological therapyFor the mother, insulin was associated with an increased risk for hypertensive disorders of pregnancy (not defined) compared to oral anti-diabetic pharmacological therapy (risk ratio (RR) 1.89, 95% confidence interval (CI) 1.14 to 3.12; four studies, 1214 women; moderate-quality evidence). There was no clear evidence of a difference between those who had been treated with insulin and those who had been treated with an oral anti-diabetic pharmacological therapy for the risk of pre-eclampsia (RR 1.14, 95% CI 0.86 to 1.52; 10 studies, 2060 women; moderate-quality evidence); the risk of birth by caesarean section (RR 1.03, 95% CI 0.93 to 1.14; 17 studies, 1988 women; moderate-quality evidence); or the risk of developing type 2 diabetes (metformin only) (RR 1.39, 95% CI 0.80 to 2.44; two studies, 754 women; moderate-quality evidence). The risk of undergoing induction of labour for those treated with insulin compared with oral anti-diabetic pharmacological therapy may possibly be increased, although the evidence was not clear (average RR 1.30, 95% CI 0.96 to 1.75; three studies, 348 women; I² = 32%; moderate-quality of evidence). There was no clear evidence of difference in postnatal weight retention between women treated with insulin and those treated with oral anti-diabetic pharmacological therapy (metformin) at six to eight weeks postpartum (MD -1.60 kg, 95% CI -6.34 to 3.14; one study, 167 women; low-quality evidence) or one year postpartum (MD -3.70, 95% CI -8.50 to 1.10; one study, 176 women; low-quality evidence). The outcomes of perineal trauma/tearing or postnatal depression were not reported in the included studies.For the infant, there was no evidence of a clear difference between those whose mothers had been treated with insulin and those treated with oral anti-diabetic pharmacological therapies for the risk of being born large-for-gestational age (average RR 1.01, 95% CI 0.76 to 1.35; 13 studies, 2352 infants; moderate-quality evidence); the risk of perinatal (fetal and neonatal death) mortality (RR 0.85; 95% CI 0.29 to 2.49; 10 studies, 1463 infants; low-quality evidence);, for the risk of death or serious morbidity composite (RR 1.03, 95% CI 0.84 to 1.26; two studies, 760 infants; moderate-quality evidence); the risk of neonatal hypoglycaemia (average RR 1.14, 95% CI 0.85 to 1.52; 24 studies, 3892 infants; low-quality evidence); neonatal adiposity at birth (% fat mass) (mean difference (MD) 1.6%, 95% CI -3.77 to 0.57; one study, 82 infants; moderate-quality evidence); neonatal adiposity at birth (skinfold sum/mm) (MD 0.8 mm, 95% CI -2.33 to 0.73; random-effects; one study, 82 infants; very low-quality evidence); or childhood adiposity (total percentage fat mass) (MD 0.5%; 95% CI -0.49 to 1.49; one study, 318 children; low-quality evidence). Low-quality evidence also found no clear differences between groups for rates of neurosensory disabilities in later childhood: hearing impairment (RR 0.31, 95% CI 0.01 to 7.49; one study, 93 children), visual impairment (RR 0.31, 95% CI 0.03 to 2.90; one study, 93 children), or any mild developmental delay (RR 1.07, 95% CI 0.33 to 3.44; one study, 93 children). Later infant mortality, and childhood diabetes were not reported as outcomes in the included studies.We also looked at comparisons for regular human insulin versus other insulin analogues, insulin versus diet/standard care, insulin versus exercise and comparisons of insulin regimens, however there was insufficient evidence to determine any differences for many of the key health outcomes. Please refer to the main results for more information about these comparisons.

Authors' conclusions: The main comparison in this review is insulin versus oral anti-diabetic pharmacological therapies. Insulin and oral anti-diabetic pharmacological therapies have similar effects on key health outcomes. The quality of the evidence ranged from very low to moderate, with downgrading decisions due to imprecision, risk of bias and inconsistency.For the other comparisons of this review (insulin compared with non-pharmacological interventions, different insulin analogies or different insulin regimens), there is insufficient volume of high-quality evidence to determine differences for key health outcomes.Long-term maternal and neonatal outcomes were poorly reported for all comparisons.The evidence suggests that there are minimal harms associated with the effects of treatment with either insulin or oral anti-diabetic pharmacological therapies. The choice to use one or the other may be down to physician or maternal preference, availability or severity of GDM. Further research is needed to explore optimal insulin regimens. Further research could aim to report data for standardised GDM outcomes.

PubMed Disclaimer

Conflict of interest statement

Julie Brown: Julie Brown has received a University of Auckland Departmental Grant to support the preparation of an overview of treatments for women with gestational diabetes. This review is one of the reviews to be included in the overview.

Luke Grzeskowiak: none known.

Michelle Downie: has received honorarium for lectures (and partial sponsorship to attend conferences) from Novo Nordisk and Sanofi Aventis.

Caroline A Crowther: none known.

Kathryn Williamson: has been awarded the Auckland Medical Research Foundation Ruth Spencer Fellowship in support of her doctoral studies at the University of Auckland.

Figures

1
1
Study flow diagram.
2
2
Funnel plot of comparison: 1 Insulin versus anti‐diabetic agent, outcome: 1.3 Caesarean section.
3
3
Funnel plot of comparison: 1 Insulin versus anti‐diabetic agent, outcome: 1.6 Large‐for‐gestational age (Birthweight > 90th centile).
4
4
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
5
5
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD012037

References

References to studies included in this review

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    1. Spaulonci CP, Bernardes LS, Trindade TC, Zugaib M, Francisco RPV. Randomized trial of metformin versus insulin in the management of gestational diabetes. American Journal of Obstetrics and Gynecology 2013;209(1):34.e1‐34.e7. - PubMed
Tertti 2013 {published data only}
    1. NCT02417090. Late metabolic effects of metformin therapy in gestational diabetes (DIARA2). clinicaltrials.gov/ct2/show/NCT02417090 Date first received: 10 April 2015.
    1. Pellonpera O, Ronnemaa T, Ekblad U, Vahlberg T, Tertti K. The effects of metformin treatment of gestational diabetes on maternal weight and glucose tolerance post‐partum‐ a prospective follow‐up study. Acta Obstetricia et Gynecologica Scandinavica 2016;95(1):79‐87. - PubMed
    1. Tertti K, Ekblad U, Koskinen P, Vahlberg T, Ronnemaa T. Metformin vs. insulin in gestational diabetes. A randomized study characterizing metformin patients needing additional insulin. Diabetes, Obesity & Metabolism 2013;15(3):246‐51. - PubMed
    1. Tertti K, Eskola E, Ronnemaa T, Haataja L. Neurodevelopment of two‐year old children exposed to metformin and insulin in gestational diabetes mellitus. Journal of Developmental and Behavioral Pediatrics 2015;36:752‐7. - PubMed
    1. Tertti K, Laine K, Ekblad U, Rinne V, Ronnemaa T. The degree of fetal metformin exposure does not influence fetal outcome in gestational diabetes mellitus. Acta Diabetologica 2014;51:731‐8. - PubMed
Thompson 1990 {published data only}
    1. Thompson DJ, Porter KB, Gunnells DJ, Wagner PC, Spinnato JA. Prophylactic insulin in the management of gestational diabetes. Obstetrics & Gynecology 1990;75:960‐4. - PubMed
Waheed 2013 {published data only}
    1. Waheed S, Malik FP, Mazhar SB. Efficacy of metformin versus insulin in the management of pregnancy with diabetes. Journal of the College of Physicians and Surgeons Pakistan 2013;23(12):866‐9. - PubMed
Wali 2015 {unpublished data only}
    1. ACTRN12612001272886. A phase three open label randomized controlled trial to compare the efficacy of oral hypoglycaemic agents (OHA) with insulin in the treatment of gestational diabetes mellitus (GDM). anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363218 Date first received: 7 December 2012.
    1. Wali A, Sheikh A, Sheikh L, Babar N, Nausheen S, Akhter J. A phase three open label randomized controlled trial to compare the efficacy of oral hypoglycaemic agents (OHA) with insulin in the treatment of gestational diabetes mellitus (GDM). Diabetes 2015;64:A378.
Zangeneh 2014 {published data only}
    1. IRCT201010203797N2. The comparative study if therapeutic effects of insulin and glibenclamide in the gestational diabetes mellitus. en.search.irct.ir/view/4374 Date first received: 1 December 2010.
    1. Zangeneh M, Veisi F, Ebrahimi B, Rezavand N. Comparison of therapeutic effects of insulin and glibenclamide in gestational diabetes. Iranian Journal of Obstetrics, Gynecology and Infertility 2014;17(124):1‐7.
Zawiejska 2016 {published data only}
    1. Zawiejska A, Wender‐Ozegowska E, Grewling‐Szmit K, Brazert M, Brazert J. Short‐term antidiabetic treatment with insulin or metformin has a similar impact on the components of metabolic syndrome in women with gestational diabetes mellitus requiring antidiabetic agents: Results of a prospective, randomised study. Journal of Physiology and Pharmacology 2016;67(2):227‐33. - PubMed

References to studies excluded from this review

Ainuddin 2015 {published data only}
    1. Ainuddin JA, Karim N, Zaheer S, Ali SS, Hasan AA. Metformin treatment in type 2 diabetes in pregnancy: an active controlled, parallel‐group, randomized, open label study in patients with type 2 diabetes in pregnancy. Journal of Diabetes Research 2015;2015:325851. - PMC - PubMed
Ainuddin 2015a {published data only}
    1. Ainuddin J, Karim N, Hasan AA, Naqvi SA. Metformin versus insulin treatment in gestational diabetes in pregnancy in a developing country: a randomized control trial. Diabetes Research and Clinical Practice 2015;107(2):290‐99. - PubMed
    1. NCT01855763. Metformin treatment in gestational diabetes and non‐insulin dependent diabetes in pregnancy in a developing country. clinicaltrials.gov/show/NCT01855763 Date first received: 9 May 2013.
Brennan 2015 {published data only}
    1. Brennan T, Savitsky L, Frias A, Caughey A. Treating gestational diabetes mellitus with insulin cs glyburide: a cost effectiveness study. American Journal of Obstetrics and Gynecology 2015;212(1):S350.
Coiner 2014 {published data only}
    1. Coiner J, Rowe M, DeVente J. The treatment of diabetes in pregnancy; metformin vs glyburide and insulin biomedical evidence of fetopathy. American Journal of Obstetrics and Gynecology 2014; Vol. 210, issue 1 Suppl 1:S148.
Fadl 2015 {published data only}
    1. Fadl HE, Gardefors S, Hjertberg R, Nord E, Persson B, Schwarcz E, et al. Randomized controlled study in pregnancy on treatment of marked hyperglycaemia that is short of overt diabetes. Acta Obstetricia et Gynecologica Scandinavica 2015;94(11):1181‐7. - PubMed
    1. NCT00625781. Treatment of impaired glucose tolerance in pregnancy. clinicaltrials.gov/show/NCT00625781 Date first received: 1 February 2008.
Hassan 2012 {published data only}
    1. Hassan JA, Karim, Sheikh Z. Metformin prevents macrosomia and neonatal morbidity in gestational diabetes. Pakistan Journal of Medical Sciences 2012;28(3):384‐9.
Hopp 1996 {published data only}
    1. Hopp H, Vollert W, Ragosch V, Novak A, Weitzel HK, Glockner E, et al. Indication and results of insulin therapy for gestational diabetes mellitus. Journal of Perinatal Medicine 1996;24:521‐30. - PubMed
    1. Novak A, Hopp H, Vollert W, Weitzel H, Glockner E. Fetal indication for insulin therapy in gestational diabetes. Proceedings of 14th European Congress of Perinatal Medicine; 1994 June 5‐8; Helsinki, Finland. Helsinki, Finland, 1994:Abstract no: 318.
Kitzmiller 1990 {unpublished data only}
    1. Kitzmiller JL. Trial of diet vs diet plus insulin for gestational diabetes. Personal communication 1990.
Landon 2015 {published data only}
    1. Landon MB, Rice MM, Varner MW, Casey BM, Reddy UM, Wapner RJ, et al. Mild gestational diabetes mellitus and long‐term child health. Diabetes Care 2015;38(3):445‐52. - PMC - PubMed
Li 1987 {published data only}
    1. Li DFH, Wong VCW, O'Hoy KMKY, Yeung CY, Ma HK. Is treatment needed for mild impairment of glucose tolerance in pregnancy? A randomized controlled trial. British Journal of Obstetrics and Gynaecology 1987;94:851‐4. - PubMed
Li 1999 {published data only}
    1. Li P, Yang H, Dong Y. Treating women with gestational impaired glucose tolerance reduces adverse outcome of pregnancy. Zhonghua Fu Chan Ke Za Zhi 1999;34(8):462‐4. - PubMed
Maresh 1983 {published data only}
    1. Gillmer MDG, Maresh M, Beard RW, Elkeles RS, Alderson C, Bloxham B. Low energy diets in the treatment of gestational diabetes. Acta Endocrinologica 1986;277(Supplementum):44‐9. - PubMed
    1. Maresh M, Alderson C, Beard RW, Bloxham B, Elkeles RS, Gillmer MDG. Comparison of insulin against diet treatment in the management of abnormal carbohydrate tolerance in pregnancy. Campbell DM, Gillmer MDG, editor(s). Nutrition in pregnancy. Proceedings of 10th Study Group of the RCOG. London: RCOG, 1983:255‐67.
    1. Maresh M, Gillmer MDG, Beard RW, Alderson CS, Bloxham BA, Elkeles RS. The effect of diet and insulin on metabolic profiles of women with gestational diabetes mellitus. Diabetes 1985;34:88‐93. - PubMed
Munshi 2014 {published data only}
    1. Munshi S, Khandaker S. Evaluation of metformin versus insulin in the management of gestational diabetes mellitus: a prospective comparative study. International Journal of Reproduction, Contraception, Obstetrics and Gynecology 2014;3(2):357‐61.
NCT00678080 {unpublished data only}
    1. NCT00678080. Metformin versus insulin in pregnant women with type 2 diabetes. clinicaltrials.gov/show/NCT00678080 Date first received: 8 May 2008.
O'Sullivan 1971 {published data only}
    1. O'Sullivan JB, Charles D, Dandrow RV. Treatment of verified prediabetics in pregnancy. Journal of Reproductive Medicine 1971;7:21‐4.
    1. O'Sullivan JB, Mahan CM, Charles D, Dandrow RV. Medical treatment of the gestational diabetic. Obstetrics and Gynecology 1974;43(6):817‐21. - PubMed
Palatnik 2015 {published data only}
    1. Palatnik A, Mele L, Landon MB, Reddy UM, Ramin SM, Carpenter MW, et al. Timing of treatment initiation for mild gestational diabetes mellitus and perinatal outcomes. American Journal of Obstetrics & Gynecology 2015;213(4):560.e1‐8. - PMC - PubMed
Pettitt 2003 {published data only}
    1. Pettitt DJ, Ospina P, Kolaczynski JW, Jovanovic L. Comparison of an insulin analog, insulin aspart, and regular human insulin with no insulin in gestational diabetes mellitus. Diabetes Care 2003;26(1):183‐6. - PubMed
Schuster 1998 {published data only}
    1. Schuster MW, Chauhan SP, McLaughlin BN, Perry KG Jr, Morrison JC. Comparison on insulin regimens and administration modalities in pregnancy complicated by diabetes. Journal of the Mississippi State Medical Association 1998;39(2):51‐5. - PubMed
Smith 2015 {published data only}
    1. Smith J, Sallman MA, Berens P, Viteri O, Hutchinson M, Ramin S, et al. Metformin improved lipid profiles in women with gestational diabetes in the first six weeks postpartum. American Journal of Obstetrics and Gynecology 2015;212(1 Suppl):S324.
Snyder 1998 {published data only}
    1. Snyder J, Morin L, Meltzer S, Nadeau J. Gestational diabetes and glycemic control: A randomized clinical trial. American Journal of Obstetrics and Gynecology. 1998; Vol. 178(1 Pt 2):S55.
Tempe 2013 {published data only}
    1. Tempe A, Mayanglambam RD. Glyburide as treatment option for gestational diabetes. Journal of Obstetrics and Gynaecology Research 2013;39(6):1147‐52. - PubMed

References to studies awaiting assessment

Afshari 2013 {published data only}
    1. Afshari F, Abbasalizade F, Faraji M. Comparative evaluation of two treatment regimens, diet versus insulin, in gestational diabetes. European Journal of Experimental Biology 2013;3(4):71‐6.
Dunne 2001 {published data only}
    1. Dunne FP. Randomized trial of twice daily versus four times daily insulin regimens for the treatment of gestational diabetes and gestationally acquired impaired glucose tolerance. National Research Register (www.nrr.nhs.uk) (accessed 2001) 2001.
Ibrahim 2014 {published data only}
    1. Ibrahim M, Hamdy A, Shafik A, Taha S, Anwar M, Faris M. The role of adding metformin in insulin‐resistant diabetic pregnant women: a randomized controlled trial. Archives of Gynecology and Obstetrics 2014;289:959‐65. - PubMed
Liang 2009 {published data only}
    1. Liang HY, Hou F, Ding YL, Zhang WN, Huang XH, Zhang BY, et al. Clinical evaluation of the antioxidant activity of astragalus in women with gestational diabetes. Journal of Southern Medical University 2009;29(7):1402‐4. - PubMed
NCT00160485 {unpublished data only}
    1. NCT00160485. Glyburide compared to insulin in the management of White's classification A2 gestational diabetes. clinicaltrials.gov/show/NCT00160485 Date first received: 8 September 2005.
Shaikh 2013 {published data only}
    1. Shaikh N, Safinaz S, Shahnaz R. Can metformin be used in place of insulin for the treatment of GDM in low resource countries?. BJOG: an international journal of obstetrics and gynaecology 2013;120:35.
Todorova 2007 {published data only}
    1. Todorova K, Palaveev O, Petkova VB, Stefanova M, Dimitrova Z. A pharmacoeconomical model for choice of a treatment for pregnant women with gestational diabetes. Acta Diabetologica 2007;44(3):144‐8. - PubMed
Zhou 2012 {published data only}
    1. Zhou L, Fan L. Efficacy and safety of insulin aspart versus regular human insulin for women with gestational diabetes mellitus. Zhonghua Yi Xue Za Zhi 2012;92(19):1334‐6. - PubMed

References to ongoing studies

CTRI/2011/08/001956 {unpublished data only}
    1. CTRI/2011/08/001956. Can oral medication replace insulin injections in pregnant women with diabetes. ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=3378 Date first received: 19 August 2011.
CTRI/2013/10/004055 {unpublished data only}
    1. CTRI/2013/10/004055. Use of oral hypoglycemic drug in pregnant diabetic women. ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5526 Date first received: 10 October 2013.
CTRI/2014/08/004835 {unpublished data only}
    1. CTRI/2014/08/004835. A clinical trial to compare the effects of metformin versus insulin in patients with diabetes in pregnancy. ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8579 Date first received: 8 July 2014.
IRCT2013102315045N2 {unpublished data only}
    1. IRCT2013102315045N2. Effect of glibenclamide in women with gestational diabetes on maternal and neonatal outcomes. en.search.irct.ir/view/15526 Date first received: 19 April 2014.
IRCT2014010116025N1 {unpublished data only}
    1. IRCT2014010116025N1. Comparing of the effectiveness of insulin and metformin in treating gestational diabetes. en.search.irct.ir/view/16457 Date first received: 18 May 2014.
NCT00414245 {unpublished data only}
    1. NCT00414245. Metformin for the treatment of diabetes in pregnancy. clinicaltrials.gov/NCT00414245 Date first received: 20 December 2006.
NCT00681460 {unpublished data only}
    1. NCT00681460. Metformin in gestational diabetes mellitus (MetGDM). clinicaltrials.gov/show/NCT00681460 Date first received: 19 May 2008.
NCT00835861 {published data only}
    1. NCT00835861. Effectiveness of metformin compared to insulin in pregnant women with mild pre‐existing or early gestational diabetes (MIPOD). clinicaltrials.gov/show/NCT00835861 Date first received 2 February 2009.
NCT01613807 {published data only}
    1. NCT01613807. Humalog Mix 50/50 (tm) as a treatment for gestational diabetes. clinicaltrials.gov/showNCT01613807 Date first received: 5 June 2012.
NCT01662921 {published data only}
    1. NCT01662921. Comparator trial using insulin glulisine vs insulin lispro for treatment of gestational diabetes. clinicaltrials.gov/show/NCT01662921 Date first received: 7 August 2012.
NCT01731431 {published data only}
    1. NCT01731431. Multicenter randomized trial of non‐inferiority between glyburide and insulin for the treatment of gestational diabetes (INAO). clinicaltrials.gov/show/NCT01731431 Date first received: 11 September 2012.
NCT01756105 {unpublished data only}
    1. NCT01756105. Efficacy of metformin in achieving glycaemia goals as recommended for the treatment of gestational diabetes in non obese women. clinicaltrials.gov/show/NCT01756105 Date first received: 19 December 2012.
NCT02080377 {published data only}
    1. NCT02080377. A feasibility study looking at the use of glibenclamide and metformin versus standard care in gestational diabetes (GRACES). clinicaltrials.gov/show/NCT02080377 Date first received: 11 February 2014.
NCT03106870 {published data only}
    1. NCT03106870. Adding metformin to insulin in controlling pregestational and gestational diabetes mellitus. clinicaltrials.gov/show/NCT03106870 Date first received 28 March 2017.
SLCTR/2011/009 {unpublished data only}
    1. SLCTR/2011/009. Treatment with metformin to reduce insulin requirements in diabetes in pregnancy. slctr.lk/trials/35 Date first received: 24 June 2011.

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