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Simmons, David
Publications (10 of 10) Show all publications
Fadl, H., Saeedi, M., Montgomery, S., Magnuson, A., Schwarcz, E., Berntorp, K., . . . Simmons, D. (2019). Changing diagnostic criteria for gestational diabetes in Sweden: a stepped wedge national cluster randomised controlled trial-the CDC4G study protocol. BMC Pregnancy and Childbirth, 19(1), Article ID 398.
Open this publication in new window or tab >>Changing diagnostic criteria for gestational diabetes in Sweden: a stepped wedge national cluster randomised controlled trial-the CDC4G study protocol
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2019 (English)In: BMC Pregnancy and Childbirth, ISSN 1471-2393, E-ISSN 1471-2393, Vol. 19, no 1, article id 398Article in journal (Refereed) Published
Abstract [en]

Background: The optimal criteria to diagnose gestational diabetes mellitus (GDM) remain contested. The Swedish National Board of Health introduced the 2013 WHO criteria in 2015 as a recommendation for initiation of treatment for hyperglycaemia during pregnancy. With variation in GDM screening and diagnostic practice across the country, it was agreed that the shift to new guidelines should be in a scientific and structured way. The aim of the Changing Diagnostic Criteria for Gestational Diabetes (CDC4G) in Sweden () is to evaluate the clinical and health economic impacts of changing diagnostic criteria for GDM in Sweden and to create a prospective cohort to compare the many long-term outcomes in mother and baby under the old and new diagnostic approaches.

Methods: This is a stepped wedge cluster randomised controlled trial, comparing pregnancy outcomes before and after the switch in GDM criteria across 11 centres in a randomised manner. The trial includes all pregnant women screened for GDM across the participating centres during January-December 2018, approximately two thirds of all pregnancies in Sweden in a year. Women with pre-existing diabetes will be excluded. Data will be collected through the national Swedish Pregnancy register and for follow up studies other health registers will be included.

Discussion: The stepped wedge RCT was chosen to be the best study design for evaluating the shift from old to new diagnostic criteria of GDM in Sweden. The national quality registers provide data on the whole pregnant population and gives a possibility for follow up studies of both mother and child. The health economic analysis from the study will give a solid evidence base for future changes in order to improve immediate pregnancy, as well as long term, outcomes for mother and child.

Place, publisher, year, edition, pages
BMC, 2019
Keywords
Gestational diabetes mellitus, Pregnancy outcomes, Diagnostic criteria, WHO 2013 criteria, Stepped wedge cluster randomised controlled trial, LGA, Health economics, Obesity
National Category
Obstetrics, Gynecology and Reproductive Medicine
Identifiers
urn:nbn:se:oru:diva-77999 (URN)10.1186/s12884-019-2547-5 (DOI)000494447700004 ()31675922 (PubMedID)2-s2.0-85074418210 (Scopus ID)
Funder
Swedish Research Council, 2018-00470
Note

Funding Agencies:

Fru Mary von Sydows, född Wijk, donation fond  1017 4917 2618

Nyckelfonden Region Örebro County  OLL-597601

Region Örebro County Research committee  OLL-693551 OLL-786911

Regional Research committee Uppsala-Örebro  RFR-749241

Available from: 2019-11-22 Created: 2019-11-22 Last updated: 2019-11-22Bibliographically approved
Hildén, K., Hanson, U., Persson, M., Magnuson, A., Simmons, D. & Fadl, H. (2019). Gestational diabetes and adiposity are independent risk factors for perinatal outcomes: a population based cohort study in Sweden. Diabetic Medicine, 36(2), 151-157
Open this publication in new window or tab >>Gestational diabetes and adiposity are independent risk factors for perinatal outcomes: a population based cohort study in Sweden
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2019 (English)In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 36, no 2, p. 151-157Article in journal (Refereed) Published
Abstract [en]

AIMS: To evaluate the interaction effects of gestational diabetes (GDM) with obesity on perinatal outcomes.

METHODS: A population-based cohort study in Sweden excluding women without pre-gestational diabetes with a singleton birth between 1998 and 2012. Logistic regression was performed to evaluate the potential independent associations of GDM and BMI with adverse perinatal outcomes as well as their interactions. Main outcome measures were malformations, stillbirths, perinatal mortality, low Apgar score, fetal distress, prematurity and Erb's palsy.

RESULTS: ) had significantly increased risks of all outcomes including stillbirth 1.51 (1.40-1.62) to 2.85 (2.52-3.22) and perinatal mortality 1.49 (1.40-1.59) to 2.83 (2.54-3.15).

CONCLUSIONS: There is no interaction effect between GDM and BMI for the studied outcomes. Higher BMI and GDM are major independent risk factors for most serious adverse perinatal outcomes. More effective pre-pregnancy and antenatal interventions are required to prevent serious adverse pregnancy outcomes among women with either GDM or high BMI.

Place, publisher, year, edition, pages
Wiley-Blackwell Publishing Inc., 2019
National Category
Endocrinology and Diabetes
Identifiers
urn:nbn:se:oru:diva-72039 (URN)10.1111/dme.13843 (DOI)000457530200003 ()30698864 (PubMedID)2-s2.0-85060805274 (Scopus ID)
Note

Funding Agency:

Örebro County Council 

Available from: 2019-02-12 Created: 2019-02-12 Last updated: 2019-02-19Bibliographically approved
Hildén, K., Hanson, U., Persson, M., Magnuson, A., Simmons, D. & Fadl, H. (2018). Are gestational diabetes and adiposity independent risk factors for perinatal outcomes?: A population based cohort study in Sweden. Diabetic Medicine
Open this publication in new window or tab >>Are gestational diabetes and adiposity independent risk factors for perinatal outcomes?: A population based cohort study in Sweden
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2018 (English)In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491Article in journal (Refereed) Accepted
Place, publisher, year, edition, pages
Hoboken, USA: Wiley-Blackwell Publishing Inc., 2018
National Category
Endocrinology and Diabetes
Identifiers
urn:nbn:se:oru:diva-69788 (URN)
Available from: 2018-10-24 Created: 2018-10-24 Last updated: 2019-06-14Bibliographically approved
Hildén, K., Arntyr-Hellgren, P., Magnuson, A., Hanson, U., Simmons, D. & Fadl, H. (2018). Born over 4500 g: the trends in birth trauma and mode of delivery in women with GDM and type 1 diabetes in Sweden between 1998-2012. In: : . Paper presented at Diabetes Pregnancy Study Group (DPSG) Meeting 2018, Rome, Italy, September 27-30, 2018.
Open this publication in new window or tab >>Born over 4500 g: the trends in birth trauma and mode of delivery in women with GDM and type 1 diabetes in Sweden between 1998-2012
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2018 (English)Conference paper, Poster (with or without abstract) (Refereed)
Abstract [en]

Background: We have previously shown that during the years 1998-2012, the overall incidence of LGA and birthweight decreased in both women with and without GDM in Sweden, and unpublished preliminary results show that there is a converse trend among women with T1DM. The incidence of Erbs palsy also decreased in the GDM and background population, but remained unchanged for women with T1DM. Since macrosomia is one of the most prominent risk factors for Erb´s palsy and delivery complications, the aim of the study was to evaluate trends in incidence of Erb´s palsy and delivery mode in the macrosomic group defined as weight ≥4500g and we present here our preliminary results.

Method: This is a cohort study in Sweden 1998-2012 , including singleton macrosomic (≥4500 g) births. Vaginal deliveries were selected for the analyses relating to Erb´s plasy. Poisson regression was used to evaluate trends per year in both the GDM, T1DM and the background population. Results were partly stratified on BMI, to be able to detect any group differences in trends. P-value of <0.05 was considered statistically significant.

Results: In total there were 57 2015 macrosomic infants, of whom (n= 36 933, 64,6%) were delivered vaginally. Of these, only 2.1 % (n=798) were vaginally delivered by women with GDM, (1.4%) type 2 diabetes (0.1%) or T1DM (0.7%). The trend in Erb´s palsy decreased significantly in the background population at a rate of OR 0.954 (95% CI 0.936-0.973) per year. For women with GDM or T1DM there was no significant change in incidence of trends over these years for Erb´s palsy. As for Caesarean section (CS) there was a significant increase per year for GDM pregnancies (OR 1.028, 95% CI 1.007-1.049) and in the background population (1.018 95% CI 1.013-1.022). No change was seen for CS in pregnancies with T1DM.

Conclusion: Even though the rates of LGA and birthweight have decreased in Sweden over this time period for women with GDM and the background population, we could not see a significant decrease in Erb´s palsy among women with vaginal births in either the GDM group or for women with T1DM in the macrosomic infants. However, a decrease was seen in the incidence of Erb´s palsy in the macrosomic babies in the background population. The rates of CS have significantly increased in the background population and for GDM pregnancies, but been stable for T1DM. We conclude that the disparity in risk of Erbs has grown over this time period. Further work is needed to ascertain whether this is due to the need for improved surveillance, a higher CS rate, and/or improved glycaemic management (or other factors).

National Category
Endocrinology and Diabetes Obstetrics, Gynecology and Reproductive Medicine
Identifiers
urn:nbn:se:oru:diva-69522 (URN)
Conference
Diabetes Pregnancy Study Group (DPSG) Meeting 2018, Rome, Italy, September 27-30, 2018
Available from: 2018-10-15 Created: 2018-10-15 Last updated: 2018-10-15Bibliographically approved
Saeedi, M., Hanson, U., Simmons, D. & Fadl, H. (2018). Characteristics of different risk factors and fasting plasma glucose for identifying GDM when using IADPSG criteria: a cross-sectional study. BMC Pregnancy and Childbirth, 18(1), Article ID 225.
Open this publication in new window or tab >>Characteristics of different risk factors and fasting plasma glucose for identifying GDM when using IADPSG criteria: a cross-sectional study
2018 (English)In: BMC Pregnancy and Childbirth, ISSN 1471-2393, E-ISSN 1471-2393, Vol. 18, no 1, article id 225Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: The Swedish National Board of Health and Welfare (SNBHW) recommended the new diagnostic criteria for GDM based upon Hyperglycaemia and Adverse Pregnancy Outcomes (HAPO) study thresholds. Due to limited knowledge base, no recommendations were made on GDM screening. The aim of this study is to evaluate test characteristics of risk factors and fasting blood glucose as screening tests for diagnosing GDM using diagnostic thresholds based upon HAPO study 1.75/2.0 (model I/II respectively) odds ratio for adverse pregnancy outcomes.

METHODS: This cross-sectional, population-based study included all pregnant women who attended maternal health care in Örebro County, Sweden between the years 1994-96. A 75 g OGTT with capillary fasting and 2-h blood glucose was offered to all pregnant women at week 28-32. Risk factors and repeated random glucose samples were collected. Sensitivity, specificity and predictive values of blood glucose were calculated.

RESULTS: Prevalence of GDM was 11.7% with model I and 7.2% with the model II criteria. Risk factors showed 28%, (95% CI 24-32) and 31%, (95% CI 25-37) sensitivity for model I and II respectively. A fasting cut off ≥4.8 mmol/l occurred in 24% of women with 91%, (95% CI 88-94) sensitivity and 85%, (95% CI 83-86) specificity using model I while a fasting cut off ≥5.0 mmol/l occurred in 14% with 91%, (95% CI 87-94) sensitivity and 92%, (95% CI 91-93) specificity using model II.

CONCLUSION: Risk factor screening for GDM was found to be poorly predictive of GDM but fasting glucose of 4.8-5.0 mmol/l showed good test characteristics irrespective of diagnostic model and results in a low rate of OGTTs.

Place, publisher, year, edition, pages
BioMed Central, 2018
Keywords
Gestational diabetes mellitus, Screening, Fasting plasma glucose, Risk factors, Sensitivity
National Category
Obstetrics, Gynecology and Reproductive Medicine
Identifiers
urn:nbn:se:oru:diva-67317 (URN)10.1186/s12884-018-1875-1 (DOI)000435456900003 ()29898685 (PubMedID)2-s2.0-85048591554 (Scopus ID)
Note

Funding Agency:

Research committee of Örebro County 

Available from: 2018-06-19 Created: 2018-06-19 Last updated: 2019-01-22Bibliographically approved
Valgeirsdottir, I.-R., Hanson, U., Simmons, D. & Fadl, H. (2018). Diet as treatment for GDM: enough for improving outcomes?. In: : . Paper presented at Diabetes Pregnancy Study Group (DPSG) Meeting 2018, Rome, Italy, September 27-30, 2018.
Open this publication in new window or tab >>Diet as treatment for GDM: enough for improving outcomes?
2018 (English)Conference paper, Poster (with or without abstract) (Refereed)
Abstract [en]

Introduction: We wanted to compare the excess risk of adverse maternal and neonatal outcomes for women with diet (d-GDM) and insulin treated gestational diabetes (GDM) (i-GDM) in Sweden.

Methods: A population based cohort study including all singleton pregnancies without pre-existing diabetes recorded in the Swedish Medical Birth Register between 1998 and 2012. Logistic regression analyses were used to adjust for confounders (BMI, age, smoking, country of birth and chronic hypertension). The adjusted odds ratio (aOR) with 95% confidence interval (CI) for maternal and neonatal outcomes are presented.

Results: A total of 1,441,338 singleton pregnancies were included: 14,242 women were diagnosed with GDM (1.0%), 8,851 (62.1%) d-GDM and 5,391 (37.9%) i-GDM . Mean BMI was significantly higher than background in both groups (27.8 ± 6.0 and 30.3 ± 6.5 kg/m2 in the d-GDM group and i-GDM group, respectively, vs 24.5 ± 4.4 kg/m2, both p < 0.001). The d-GDM group had significantly higher risk for preeclampsia [aOR 1.71 (95% CI 1.55-1.88)], cesarean section [aOR 1.18 (95% CI 1.11-1.25)], LGA infants [aOR 1.85 (95% CI 1.75-1.96)] and birth injury/trauma [aOR 1.88 (95% CI 1.37-2.58)] compared to the background population. The risk was even higher in the i-GDM group, preeclampsia [aOR 2.11 (95% CI 1.88-2.36)], cesarean section [aOR 1.84 (95% CI 1.73-1.96)], LGA infants [aOR 3.38 (95% CI 3.17-3.60)] and birth injury/trauma [aOR 2.26 (95% CI 1.61-3.20)].

Conclusions: Adverse outcomes in the d-GDM group were higher than the background population and higher still among those with i-GDM.

National Category
Endocrinology and Diabetes Obstetrics, Gynecology and Reproductive Medicine
Identifiers
urn:nbn:se:oru:diva-69524 (URN)
Conference
Diabetes Pregnancy Study Group (DPSG) Meeting 2018, Rome, Italy, September 27-30, 2018
Available from: 2018-10-15 Created: 2018-10-15 Last updated: 2018-10-15Bibliographically approved
Saeedi, M., Simmons, D., Magnuson, A., Montgomery, S. & Fadl, H. (2018). The CDC4G trial: Impact of Changing Diagnostic Criteria for Gestational diabetes in Sweden – a stepped wedge national cluster randomised controlled trial-study protocol. In: : . Paper presented at Diabetes Pregnancy Study Group (DPSG) Meeting 2018, Rome, Italy, September 27-30, 2018.
Open this publication in new window or tab >>The CDC4G trial: Impact of Changing Diagnostic Criteria for Gestational diabetes in Sweden – a stepped wedge national cluster randomised controlled trial-study protocol
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2018 (English)Conference paper, Poster (with or without abstract) (Refereed)
Abstract [en]

Introduction: In 2013 WHO recommended new criteria for GDM, defined as ≥5.1, ≥10.0 and/or ≥8.5 mmol/l fasting, 1 hour and/or 2 hour cut offs, which the Swedish National Board of Health adopted. With the current variation in GDM screening/diagnostic practice across Sweden and the debate over the criteria, we have established a stepped wedge cluster randomised controlled trial (SW-CRCT) to move towards a unified approach to GDM management. The objectives for the Changing Diagnostic Criteria for Gestational diabetes in Sweden (CDC4G) trial include: (1) To compare the rates of adverse neonatal and maternal outcomes before and after the change in GDM diagnostic criteria (2) To compare the health costs before and after the change and assess the net cost/saving (3)To compare the adverse outcomes and health costs using the new WHO criteria (75% excess risk) and the criteria based upon the 100% excess risk of neonatal adverse outcomes; using the national pregnancy register where all data needed is registered from the medical journals. The aim of this study is to describe the development of the study and the associated key issues.

Methods: The CDC4G study is a national prospective, unblinded, SW-CRCT of the switch from pre-existing Swedish diagnostic criteria to the WHO 2013 criteria for GDM. Each participating centre constitutes one cluster, in which the patients undergo screening for GDM following their usual approach. The time of switch to the new criteria is randomized and subsequently rolled out until all clusters (centres) have received the intervention (introduction of the new GDM regimens) during 2018. All women treated in the participating clusters (including within primary care and hospitals) will be included in the study. Women with preexisting diabetes and overt diabetes are excluded. The key issues were identification of primary outcome, recruitment of sites and undertaking the power calculation.The study is approved by the Uppsala –Örebro regional ethics board, Dnr: 2016/487.

Result: Identification of outcomes: As many women with GDM are not identified in the pre-switch period, measures that could be influenced by knowing the diagnosis (eg screening for neonatal hypoglycaemia) were excluded. The measure also needed to be frequent enough to have a large enough absolute reduction to be detected in the total obstetric population. As LGA is common (10% total population, 20% in GDM), it was decided that LGA should be primary outcome. Secondary maternal and neonate outcomes and health economic outcomes will also be evaluated. Recruitment of sites: Regions/clinics adopted the same protocols and hence were taken as ‘clusters’. There are 21 regions in Sweden and 38 clinics with annual births ranging between 540 and 10 200 births. Stockholm regions overlap so were taken as one cluster (5 clinics) . Overall 11/21 regions with 67000 births per annum agreed to participate. Annual births in Sweden is 95-100 000/year. Power calculation: With 11 clinics (clusters) participating and an intra cluster correlation of 0.0026 a minimum sample size of 47916 pregnant women (23958 before change and 23958 after change of the new GDM criteria) have 90% statistical power to detect a risk reduction of LGA by 1.5% on a population level (from 10% to 8.5%). The power calculation incorporates consideration of the varying sizes in cluster.

Discussion: Establishing a national randomised controlled trial to evaluate the impact of the WHO 2013 criteria raised several challenges, which have now been addressed. The trial has commenced and final results of the study will be analyzed and disseminated in 2019 (www.cdc4g.com).

Trial registration CDC4G is listed on the ISRCTN registry with study ID ISRCTN41918550 (15/12/2017).

National Category
Endocrinology and Diabetes Obstetrics, Gynecology and Reproductive Medicine
Identifiers
urn:nbn:se:oru:diva-69523 (URN)
Conference
Diabetes Pregnancy Study Group (DPSG) Meeting 2018, Rome, Italy, September 27-30, 2018
Available from: 2018-10-15 Created: 2018-10-15 Last updated: 2019-01-22Bibliographically approved
Fadl, H. E. & Simmons, D. (2016). Trends in diabetes in pregnancy in Sweden 1998-2012. BMJ Open Diabetes Research & Care, 4(1), Article ID e000221.
Open this publication in new window or tab >>Trends in diabetes in pregnancy in Sweden 1998-2012
2016 (English)In: BMJ Open Diabetes Research & Care, ISSN 2052-4897, Vol. 4, no 1, article id e000221Article in journal (Refereed) Published
Abstract [en]

Objective: Diabetes in pregnancy has been shown to increase in parallel with the increasing prevalence of obesity. In this national population-based study, we analyzed the trends for gestational diabetes mellitus (GDM), type 1 diabetes in pregnancy, and type 2 diabetes in pregnancy in Sweden between 1998 and 2012.

Research design and methods: A population-based cohort study using the Swedish national medical birth registry data. The time periods were categorized into 3-year intervals and adjusted for maternal body mass index (BMI), ethnicity, and age in a logistic regression.

Results: Each type of diabetes increased over the studied 15-year period. Type 1 diabetes increased by 33.2% (22.2-45.3) and type 2 diabetes by 111% (62.2-174.4) in the adjusted model. Nordic women had the highest prevalence of type 1 diabetes (0.47%) compared with other ethnic groups. The increase in GDM and, to a lesser extent, type 2 diabetes was explained by country of birth, BMI, and maternal age. The prevalence of GDM in Nordic women (0.7-0.8%) did not increase significantly over the time period.

Conclusions: All types of diabetes in pregnancy increased over the 15-year time period in Sweden. Maternal pre-pregnancy BMI remains the key factor explaining the increase in GDM/type 2 diabetes. How to turn around the growing prevalence of diabetes in pregnancy, with its short-term and long-term health effects on both mother and child, requires population-based interventions that reduce the likelihood of entering pregnancy with a raised BMI.

Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2016
National Category
Endocrinology and Diabetes
Identifiers
urn:nbn:se:oru:diva-53590 (URN)10.1136/bmjdrc-2016-000221 (DOI)000386333100050 ()27547412 (PubMedID)
Available from: 2016-11-21 Created: 2016-11-21 Last updated: 2019-03-06Bibliographically approved
Hildén, K., Magnuson, A., Montgomery, S., Schwarcz, E., Hanson, U., Simmons, D. & Fadl, H.Cardiovascular disease among women with previous preeclampsia and/or gestational diabetes mellitus: a national case control study.
Open this publication in new window or tab >>Cardiovascular disease among women with previous preeclampsia and/or gestational diabetes mellitus: a national case control study
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(English)Manuscript (preprint) (Other academic)
National Category
Endocrinology and Diabetes
Identifiers
urn:nbn:se:oru:diva-69790 (URN)
Available from: 2018-10-24 Created: 2018-10-24 Last updated: 2018-11-19Bibliographically approved
Hildén, K., Magnuson, A., Hanson, U., Simmons, D. & Fadl, H.Trends in pregnancy outcomes for women with gestational diabetes mellitus in Sweden 1998-2012: a nationwide cohort study.
Open this publication in new window or tab >>Trends in pregnancy outcomes for women with gestational diabetes mellitus in Sweden 1998-2012: a nationwide cohort study
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(English)Manuscript (preprint) (Other academic)
National Category
Endocrinology and Diabetes
Identifiers
urn:nbn:se:oru:diva-69789 (URN)
Available from: 2018-10-24 Created: 2018-10-24 Last updated: 2018-10-24Bibliographically approved
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