# Treatment of gestational diabetes (diet, glucose monitoring, insulin or metformin)

Intervention · id `maternal:gdm-treatment` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public)

> General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here.

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Browse, life stage: Pregnancy  
Browse, care area: Pregnancy conditions  

## In plain language

Treatment of gestational diabetes usually starts with healthy eating and physical activity, with home blood sugar checks, and adds medicine if that is not enough. In one trial (ACHOIS), treatment cut serious complications for babies from 4 percent to 1 percent, with more babies in the neonatal nursery and more inductions of labor. In another trial (the MFMU trial), in women with mild gestational diabetes, treatment did not significantly reduce the main combined baby outcome (32.4% against 37.0%), but fewer babies were large or had shoulder dystocia, and fewer mothers had caesarean births or high blood pressure disorders. A third trial (MiG) compared metformin with insulin and found similar baby outcomes.

## Technical summary

Each trial used its own criteria for gestational diabetes, so results are kept in separate claims on this page and are not combined: ACHOIS (infant outcomes and maternal outcomes as two claims), the MFMU trial (primary neonatal composite not significant, P=0.14; prespecified secondary neonatal and maternal outcomes as two further claims) and MiG (metformin against insulin; the abstract carries an erratum that was not read). The clinical links below are a treats link for ACHOIS, whose primary result was positive, and evaluated-for links for the MFMU trial, whose primary result was not significant, and for MiG, which compares two treatments and not treatment against none. The package of diet, monitoring and insulin as needed is tested as a whole; no trial isolates one part. Only abstracts and the MFMU registry record were read.

## Claims, with the population each applies to

## Context: Infants of women with gestational diabetes in the ACHOIS trial

Recipient: Mixed recipients; Population: Infants of the 490 women in the intervention group and the 510 women in the routine-care group. The outcomes in this context are serious perinatal complications (death, shoulder dystocia, bone fracture and nerve palsy) and admission to the neonatal nursery. The composite includes deaths before or around birth, so the context covers fetuses and newborns and is not split by recipient.; Care setting: Not stated in the PubMed abstract; Geography: Not stated in the PubMed abstract; Life stage: Birth and the neonatal period; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Perinatal period, as the complications are defined

### In the ACHOIS randomized trial, women with gestational diabetes between 24 and 34 weeks of gestation were assigned to dietary advice, blood glucose monitoring and insulin therapy as needed (intervention group) or to routine care. The rate of serious perinatal complications (death, shoulder dystocia, bone fracture and nerve palsy) was significantly lower among the infants of the 490 women in the intervention group than among the infants of the 510 women in the routine-care group (1 percent versus 4 percent; relative risk adjusted for maternal age, race or ethnic group and parity 0.33, 95 percent confidence interval 0.14 to 0.75; P=0.01). More infants of women in the intervention group were admitted to the neonatal nursery (71 percent versus 61 percent; adjusted relative risk 1.13, 95 percent confidence interval 1.03 to 1.23; P=0.01).

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Mixed recipients; Population: Infants of the 490 women in the intervention group and the 510 women in the routine-care group. The outcomes in this context are serious perinatal complications (death, shoulder dystocia, bone fracture and nerve palsy) and admission to the neonatal nursery. The composite includes deaths before or around birth, so the context covers fetuses and newborns and is not split by recipient.; Care setting: Not stated in the PubMed abstract; Geography: Not stated in the PubMed abstract; Life stage: Birth and the neonatal period; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Perinatal period, as the complications are defined
- Limitations: Only the PubMed abstract was read. The abstract gives no gestational-diabetes criteria (each trial used its own, so results from different trials are kept in separate claims), no blinding details and no counts of events, so none are recorded. The trial tested a package (diet, monitoring and insulin as needed) against routine care; it does not show the effect of any single part. Maternal outcomes are in a separate claim.
- Last checked: 2026-10-14
- Sources:
  1. Supports: Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa042973>
     Locator: Abstract, RESULTS, sentence 1. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 2852513d5a6a575b17d5c19714ae15ba4c2600979bcf12a75827532b91548801.
     How it applies: PubMed abstract of the ACHOIS report (NEJM 2005).
  2. Supports: Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa042973>
     Locator: Abstract, RESULTS, sentence 2. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 2852513d5a6a575b17d5c19714ae15ba4c2600979bcf12a75827532b91548801.
     How it applies: PubMed abstract of the ACHOIS report (NEJM 2005).
  3. Background: Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa042973>
     Locator: Abstract, BACKGROUND, sentence 1. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 2852513d5a6a575b17d5c19714ae15ba4c2600979bcf12a75827532b91548801.
     How it applies: Design, outcome definitions and the authors’ conclusion.
  4. Background: Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa042973>
     Locator: Abstract, METHODS, sentence 1. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 2852513d5a6a575b17d5c19714ae15ba4c2600979bcf12a75827532b91548801.
     How it applies: Design, outcome definitions and the authors’ conclusion.
  5. Background: Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa042973>
     Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 2852513d5a6a575b17d5c19714ae15ba4c2600979bcf12a75827532b91548801.
     How it applies: Design, outcome definitions and the authors’ conclusion.
  6. Background: Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa042973>
     Locator: Abstract, METHODS, sentence 2. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 2852513d5a6a575b17d5c19714ae15ba4c2600979bcf12a75827532b91548801.
     How it applies: Design, outcome definitions and the authors’ conclusion.

## Context: Women with gestational diabetes at 24 to 34 weeks (ACHOIS trial)

Recipient: Maternal; Population: Women between 24 and 34 weeks of gestation who had gestational diabetes, randomized to dietary advice, blood glucose monitoring and insulin therapy as needed (intervention group, 490 women) or routine care (510 women). The outcomes in this context are counted in the women: induction of labor, cesarean birth, and mood and health status at three months post partum.; Care setting: Not stated in the PubMed abstract; Geography: Not stated in the PubMed abstract; Life stage: Pregnancy (24 to 34 weeks at entry) and three months post partum; Gestational age: at least 24 weeks 0 days (168 days), measured at enrolment; Postnatal age: Not reported; Follow-up: Until birth, and mood and health status at three months post partum (data for 573 women)

### In the ACHOIS randomized trial, women in the intervention group (dietary advice, blood glucose monitoring and insulin therapy as needed) had a higher rate of induction of labor than women in the routine-care group (39 percent versus 29 percent; adjusted relative risk 1.36, 95 percent confidence interval 1.15 to 1.62; P&lt;0.001). Cesarean delivery rates were similar (31 percent and 32 percent; adjusted relative risk 0.97, 95 percent confidence interval 0.81 to 1.16; P=0.73). At three months post partum, data on mood and quality of life, available for 573 women, showed lower rates of depression and higher scores consistent with improved health status in the intervention group.

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Maternal; Population: Women between 24 and 34 weeks of gestation who had gestational diabetes, randomized to dietary advice, blood glucose monitoring and insulin therapy as needed (intervention group, 490 women) or routine care (510 women). The outcomes in this context are counted in the women: induction of labor, cesarean birth, and mood and health status at three months post partum.; Care setting: Not stated in the PubMed abstract; Geography: Not stated in the PubMed abstract; Life stage: Pregnancy (24 to 34 weeks at entry) and three months post partum; Gestational age: at least 24 weeks 0 days (168 days), measured at enrolment; Postnatal age: Not reported; Follow-up: Until birth, and mood and health status at three months post partum (data for 573 women)
- Limitations: Only the PubMed abstract was read. The abstract gives no numbers for the mood and health-status findings and they were available for 573 women (the abstract gives 490 and 510 women in the two groups). The authors conclude that treatment may improve the health-related quality of life of the woman; this is stated cautiously in the abstract and is not recorded as a finding. Infant outcomes are in a separate claim.
- Last checked: 2026-10-14
- Sources:
  1. Supports: Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa042973>
     Locator: Abstract, RESULTS, sentence 3. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 2852513d5a6a575b17d5c19714ae15ba4c2600979bcf12a75827532b91548801.
     How it applies: PubMed abstract of the ACHOIS report (NEJM 2005).
  2. Supports: Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa042973>
     Locator: Abstract, RESULTS, sentence 4. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 2852513d5a6a575b17d5c19714ae15ba4c2600979bcf12a75827532b91548801.
     How it applies: PubMed abstract of the ACHOIS report (NEJM 2005).
  3. Background: Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa042973>
     Locator: Abstract, BACKGROUND, sentence 1. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 2852513d5a6a575b17d5c19714ae15ba4c2600979bcf12a75827532b91548801.
     How it applies: Design and the authors’ conclusion.
  4. Background: Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa042973>
     Locator: Abstract, METHODS, sentence 1. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 2852513d5a6a575b17d5c19714ae15ba4c2600979bcf12a75827532b91548801.
     How it applies: Design and the authors’ conclusion.
  5. Background: Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa042973>
     Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 2852513d5a6a575b17d5c19714ae15ba4c2600979bcf12a75827532b91548801.
     How it applies: Design and the authors’ conclusion.
  6. Background: Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa042973>
     Locator: Abstract, METHODS, sentence 2. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 2852513d5a6a575b17d5c19714ae15ba4c2600979bcf12a75827532b91548801.
     How it applies: Design and the authors’ conclusion.

## Context: Infants of women with mild gestational diabetes in the MFMU trial

Recipient: Mixed recipients; Population: Infants of the women in the MFMU trial of treatment for mild gestational diabetes. The primary outcome is a neonatal composite: stillbirth or perinatal death and neonatal complications including hyperbilirubinemia, hypoglycemia, hyperinsulinemia and birth trauma. Secondary outcomes in this context include birth weight, neonatal fat mass, large for gestational age, birth weight above 4000 g and shoulder dystocia. The composite includes deaths before or around birth, so the context covers fetuses and newborns and is not split by recipient.; Care setting: Not stated in the PubMed abstract; Geography: United States (the registry lists 16 study locations in the United States).; Life stage: Birth and the neonatal period; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Delivery through hospital discharge, up to 120 days per the registry primary outcome time frame

### In the MFMU randomized trial in women with mild gestational diabetes, treatment (dietary intervention, self-monitoring of blood glucose, and insulin therapy if necessary) did not significantly reduce the primary outcome, a composite of stillbirth or perinatal death and neonatal complications including hyperbilirubinemia, hypoglycemia, hyperinsulinemia and birth trauma. The composite occurred in 32.4% of the treatment group and 37.0% of the control group (usual prenatal care; P=0.14). There were no perinatal deaths.

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Mixed recipients; Population: Infants of the women in the MFMU trial of treatment for mild gestational diabetes. The primary outcome is a neonatal composite: stillbirth or perinatal death and neonatal complications including hyperbilirubinemia, hypoglycemia, hyperinsulinemia and birth trauma. Secondary outcomes in this context include birth weight, neonatal fat mass, large for gestational age, birth weight above 4000 g and shoulder dystocia. The composite includes deaths before or around birth, so the context covers fetuses and newborns and is not split by recipient.; Care setting: Not stated in the PubMed abstract; Geography: United States (the registry lists 16 study locations in the United States).; Life stage: Birth and the neonatal period; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Delivery through hospital discharge, up to 120 days per the registry primary outcome time frame
- Limitations: The primary result was not significant and is stated first for that reason; the prespecified secondary outcomes (separate claims) favoured treatment. Only the PubMed abstract and the registry record were read. The abstract gives the percentages but not the numbers of infants analysed. The registry enrollment of 7381 and the 958 women randomized in the paper are different counts; the abstract does not explain the difference and the atlas does not reconcile them. This trial used its own criteria for mild gestational diabetes, so its result is not combined with other trials.
- Last checked: 2026-10-14
- Sources:
  1. Supports: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, RESULTS, sentence 2. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: PubMed abstract of the MFMU report (NEJM 2009).
  2. Supports: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, RESULTS, sentence 3. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: PubMed abstract of the MFMU report (NEJM 2009).
  3. Supports: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: PubMed abstract of the MFMU report (NEJM 2009).
  4. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, METHODS, sentence 1. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Design, population and primary outcome definition.
  5. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, METHODS, sentence 2. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Design, population and primary outcome definition.
  6. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, RESULTS, sentence 1. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Design, population and primary outcome definition.

### In the MFMU randomized trial, several prespecified secondary neonatal outcomes were lower with treatment than with usual care: mean birth weight (3302 g versus 3408 g), neonatal fat mass (427 g versus 464 g), large-for-gestational-age infants (7.1% versus 14.5%), birth weight greater than 4000 g (5.9% versus 14.3%) and shoulder dystocia (1.5% versus 4.0%).

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Mixed recipients; Population: Infants of the women in the MFMU trial of treatment for mild gestational diabetes. The primary outcome is a neonatal composite: stillbirth or perinatal death and neonatal complications including hyperbilirubinemia, hypoglycemia, hyperinsulinemia and birth trauma. Secondary outcomes in this context include birth weight, neonatal fat mass, large for gestational age, birth weight above 4000 g and shoulder dystocia. The composite includes deaths before or around birth, so the context covers fetuses and newborns and is not split by recipient.; Care setting: Not stated in the PubMed abstract; Geography: United States (the registry lists 16 study locations in the United States).; Life stage: Birth and the neonatal period; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Delivery through hospital discharge, up to 120 days per the registry primary outcome time frame
- Limitations: These are secondary outcomes; the primary composite was not significantly different (see the separate claim). The abstract gives no confidence intervals or P values for these comparisons, so none are recorded, and it does not say whether the secondary results were adjusted for multiple comparisons. Only the PubMed abstract was read.
- Last checked: 2026-10-14
- Sources:
  1. Supports: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, RESULTS, sentence 4. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: PubMed abstract of the MFMU report (NEJM 2009), prespecified secondary outcomes.
  2. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, RESULTS, sentence 2. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Primary result and design.
  3. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, RESULTS, sentence 3. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Primary result and design.
  4. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Primary result and design.
  5. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, METHODS, sentence 1. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Primary result and design.
  6. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, METHODS, sentence 2. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Primary result and design.
  7. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, RESULTS, sentence 1. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Primary result and design.

## Context: Women with mild gestational diabetes at 24 to 31 weeks (MFMU trial)

Recipient: Maternal; Population: Pregnant women in the 24th to 31st week of gestation who met the criteria for mild gestational diabetes mellitus (an abnormal result on an oral glucose-tolerance test but a fasting glucose level below 95 mg per deciliter \[5.3 mmol per liter\]). 958 women were randomly assigned: 485 to treatment and 473 to usual prenatal care. The outcomes in this context are counted in the women: cesarean delivery and hypertensive disorders of pregnancy.; Care setting: Not stated in the PubMed abstract; Geography: United States (the registry lists 16 study locations in the United States).; Life stage: Pregnancy (24 to 31 weeks at entry); Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Until birth and the neonatal period

### In the MFMU randomized trial, treatment of mild gestational diabetes was associated with lower rates of cesarean delivery (26.9% versus 33.8% with usual care) and of preeclampsia and gestational hypertension (combined rates for the two conditions 8.6% versus 13.6%; P=0.01).

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Maternal; Population: Pregnant women in the 24th to 31st week of gestation who met the criteria for mild gestational diabetes mellitus (an abnormal result on an oral glucose-tolerance test but a fasting glucose level below 95 mg per deciliter \[5.3 mmol per liter\]). 958 women were randomly assigned: 485 to treatment and 473 to usual prenatal care. The outcomes in this context are counted in the women: cesarean delivery and hypertensive disorders of pregnancy.; Care setting: Not stated in the PubMed abstract; Geography: United States (the registry lists 16 study locations in the United States).; Life stage: Pregnancy (24 to 31 weeks at entry); Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Until birth and the neonatal period
- Limitations: These are prespecified secondary outcomes; the primary composite (an infant outcome) was not significantly different. The abstract gives no P value or interval for the cesarean comparison. Only the PubMed abstract was read.
- Last checked: 2026-10-14
- Sources:
  1. Supports: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, RESULTS, sentence 4. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: PubMed abstract of the MFMU report (NEJM 2009), prespecified secondary outcomes.
  2. Supports: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, RESULTS, sentence 5. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: PubMed abstract of the MFMU report (NEJM 2009), prespecified secondary outcomes.
  3. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, METHODS, sentence 1. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Design and the primary result.
  4. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, METHODS, sentence 2. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Design and the primary result.
  5. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, RESULTS, sentence 1. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Design and the primary result.
  6. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, RESULTS, sentence 2. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Design and the primary result.
  7. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, RESULTS, sentence 3. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Design and the primary result.
  8. Background: A multicenter, randomized trial of treatment for mild gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa0902430>
     Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14T18:18:22Z. Source state: Current. Snapshot hash: 4fc3b6f87b9fcfd52a47852b624d5b13249e3876336162d318d2b42f0deddbd5.
     How it applies: Design and the primary result.

## Context: Infants of women with gestational diabetes treated with metformin or insulin (MiG trial)

Recipient: Newborn; Population: Infants of 751 women with gestational diabetes at 20 to 33 weeks of gestation who were randomly assigned to open treatment with metformin (with supplemental insulin if required) or insulin. The outcome is a composite of neonatal hypoglycemia, respiratory distress, need for phototherapy, birth trauma, 5-minute Apgar score less than 7, or prematurity.; Care setting: Not stated in the PubMed abstract; Geography: Not stated in the PubMed abstract; Life stage: Pregnancy (20 to 33 weeks at entry) and the neonatal period; Gestational age: at least 20 weeks 0 days (140 days), measured at enrolment; Postnatal age: Not reported; Follow-up: Neonatal period, as the composite is defined

### In the MiG randomized trial, 751 women with gestational diabetes at 20 to 33 weeks of gestation were assigned to open treatment with metformin (with supplemental insulin if required) or insulin. The primary composite outcome in the infants occurred in 32.0% of the metformin group and 32.2% of the insulin group (relative risk 0.99, 95% CI 0.80 to 1.23, values the abstract marks as corrected). The authors conclude that metformin, alone or with supplemental insulin, was not associated with increased perinatal complications compared with insulin.

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Newborn; Population: Infants of 751 women with gestational diabetes at 20 to 33 weeks of gestation who were randomly assigned to open treatment with metformin (with supplemental insulin if required) or insulin. The outcome is a composite of neonatal hypoglycemia, respiratory distress, need for phototherapy, birth trauma, 5-minute Apgar score less than 7, or prematurity.; Care setting: Not stated in the PubMed abstract; Geography: Not stated in the PubMed abstract; Life stage: Pregnancy (20 to 33 weeks at entry) and the neonatal period; Gestational age: at least 20 weeks 0 days (140 days), measured at enrolment; Postnatal age: Not reported; Follow-up: Neonatal period, as the composite is defined
- Limitations: This trial compares two drug treatments with each other and says nothing about treatment against no treatment. It was designed to rule out a 33% increase in the composite (from 30% to 40%) with metformin. The abstract gives 751 women in total, of whom 363 were assigned to metformin; of these, 92.6% continued metformin until delivery and 46.3% received supplemental insulin. The abstract marks the relative risk and interval as corrected after an erratum (N Engl J Med 2008;359(1):106, no PubMed id); the corrected values printed in the abstract are used and the erratum text was not read. The abstract also reports findings about the women (treatment preference and adverse events) that are outside this newborn claim. Treatment was open-label. Only the PubMed abstract was read.
- Last checked: 2026-10-14
- Source problem: a cited source is corrected. Check the sources before relying on this claim.
- Sources:
  1. Supports: Metformin versus insulin for the treatment of gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched. PubMed links an erratum (N Engl J Med 2008;359(1):106) that has no PubMed id; the abstract marks three of the values it prints as corrected, and the claim uses those printed values.) <https://doi.org/10.1056/NEJMoa0707193>
     Locator: Abstract, RESULTS, sentence 1. Retrieved 2026-10-14T18:18:23Z. Source state: Corrected. Snapshot hash: b2f888cca59258b896a89862b4f7c8ff44d3b718c73645012a63c376a224254b.
     How it applies: PubMed abstract of the MiG report (NEJM 2008).
  2. Supports: Metformin versus insulin for the treatment of gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched. PubMed links an erratum (N Engl J Med 2008;359(1):106) that has no PubMed id; the abstract marks three of the values it prints as corrected, and the claim uses those printed values.) <https://doi.org/10.1056/NEJMoa0707193>
     Locator: Abstract, RESULTS, sentence 2. Retrieved 2026-10-14T18:18:23Z. Source state: Corrected. Snapshot hash: b2f888cca59258b896a89862b4f7c8ff44d3b718c73645012a63c376a224254b.
     How it applies: PubMed abstract of the MiG report (NEJM 2008).
  3. Supports: Metformin versus insulin for the treatment of gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched. PubMed links an erratum (N Engl J Med 2008;359(1):106) that has no PubMed id; the abstract marks three of the values it prints as corrected, and the claim uses those printed values.) <https://doi.org/10.1056/NEJMoa0707193>
     Locator: Abstract, RESULTS, sentence 3. Retrieved 2026-10-14T18:18:23Z. Source state: Corrected. Snapshot hash: b2f888cca59258b896a89862b4f7c8ff44d3b718c73645012a63c376a224254b.
     How it applies: PubMed abstract of the MiG report (NEJM 2008).
  4. Supports: Metformin versus insulin for the treatment of gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched. PubMed links an erratum (N Engl J Med 2008;359(1):106) that has no PubMed id; the abstract marks three of the values it prints as corrected, and the claim uses those printed values.) <https://doi.org/10.1056/NEJMoa0707193>
     Locator: Abstract, RESULTS, sentence 5. Retrieved 2026-10-14T18:18:23Z. Source state: Corrected. Snapshot hash: b2f888cca59258b896a89862b4f7c8ff44d3b718c73645012a63c376a224254b.
     How it applies: PubMed abstract of the MiG report (NEJM 2008).
  5. Supports: Metformin versus insulin for the treatment of gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched. PubMed links an erratum (N Engl J Med 2008;359(1):106) that has no PubMed id; the abstract marks three of the values it prints as corrected, and the claim uses those printed values.) <https://doi.org/10.1056/NEJMoa0707193>
     Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14T18:18:23Z. Source state: Corrected. Snapshot hash: b2f888cca59258b896a89862b4f7c8ff44d3b718c73645012a63c376a224254b.
     How it applies: PubMed abstract of the MiG report (NEJM 2008).
  6. Supports: Metformin versus insulin for the treatment of gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched. PubMed links an erratum (N Engl J Med 2008;359(1):106) that has no PubMed id; the abstract marks three of the values it prints as corrected, and the claim uses those printed values.) <https://doi.org/10.1056/NEJMoa0707193>
     Locator: Abstract, CONCLUSIONS, sentence 2. Retrieved 2026-10-14T18:18:23Z. Source state: Corrected. Snapshot hash: b2f888cca59258b896a89862b4f7c8ff44d3b718c73645012a63c376a224254b.
     How it applies: PubMed abstract of the MiG report (NEJM 2008).
  7. Background: Metformin versus insulin for the treatment of gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched. PubMed links an erratum (N Engl J Med 2008;359(1):106) that has no PubMed id; the abstract marks three of the values it prints as corrected, and the claim uses those printed values.) <https://doi.org/10.1056/NEJMoa0707193>
     Locator: Abstract, METHODS, sentence 1. Retrieved 2026-10-14T18:18:23Z. Source state: Corrected. Snapshot hash: b2f888cca59258b896a89862b4f7c8ff44d3b718c73645012a63c376a224254b.
     How it applies: Design, outcome definition and non-inferiority margin.
  8. Background: Metformin versus insulin for the treatment of gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched. PubMed links an erratum (N Engl J Med 2008;359(1):106) that has no PubMed id; the abstract marks three of the values it prints as corrected, and the claim uses those printed values.) <https://doi.org/10.1056/NEJMoa0707193>
     Locator: Abstract, METHODS, sentence 2. Retrieved 2026-10-14T18:18:23Z. Source state: Corrected. Snapshot hash: b2f888cca59258b896a89862b4f7c8ff44d3b718c73645012a63c376a224254b.
     How it applies: Design, outcome definition and non-inferiority margin.
  9. Background: Metformin versus insulin for the treatment of gestational diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. The full text and the version of record were not fetched. PubMed links an erratum (N Engl J Med 2008;359(1):106) that has no PubMed id; the abstract marks three of the values it prints as corrected, and the claim uses those printed values.) <https://doi.org/10.1056/NEJMoa0707193>
     Locator: Abstract, METHODS, sentence 3. Retrieved 2026-10-14T18:18:23Z. Source state: Corrected. Snapshot hash: b2f888cca59258b896a89862b4f7c8ff44d3b718c73645012a63c376a224254b.
     How it applies: Design, outcome definition and non-inferiority margin.

## Connected pages

- Filed under this front: Medicines and vaccines (`maternal:front-medicines-and-vaccines`)
- ACHOIS: serious perinatal complications 1% with treatment versus 4% with routine care (adjusted RR 0.33, 95% CI 0.14 to 0.75): Gestational diabetes (`maternal:gestational-diabetes`) [a claim, not a settled fact; see claim `maternal:claim-achois-serious-perinatal-complications` and its context]
- MFMU trial in mild gestational diabetes: the primary neonatal composite was not significantly reduced (32.4% versus 37.0%, P=0.14); several secondary outcomes favoured treatment: Gestational diabetes (`maternal:gestational-diabetes`) [a claim, not a settled fact; see claim `maternal:claim-mfmu-primary-neonatal-composite` and its context]
- MiG trial: metformin versus insulin gave similar rates of the neonatal composite (32.0% versus 32.2%): Gestational diabetes (`maternal:gestational-diabetes`) [a claim, not a settled fact; see claim `maternal:claim-mig-metformin-versus-insulin-neonatal-composite` and its context]
- Investigated in: ACHOIS trial (treatment of gestational diabetes) (`maternal:achois-trial`)
- Investigated in: MFMU trial of treatment for mild gestational diabetes (`maternal:mfmu-mild-gdm-trial`)

## Provenance

Content hash: 11a2b0d1223dcd22d37fbc10b1943c722208c5b8ef3d24e28b90e236ba1e4987
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14