The accuracy of haemoglobin A1c as a screening and diagnostic test for gestational diabetes: a systematic review and meta-analysis of test accuracy studies

PURPOSE OF REVIEW: Gestational diabetes mellitus (GDM) is associated with adverse pregnancy complications. Accurate screening and diagnosis of gestational diabetes are critical to treatment, and in a pandemic scenario like coronavirus disease 2019 needing a simple test that minimises prolonged hospital stay. We undertook a meta-analysis on the screening and diagnostic accuracy of the haemoglobin A1c (HbA1c) test in women with and without risk factors for gestational diabetes. RECENT FINDINGS: Unlike the oral glucose tolerance test, the HbA1c test is simple, quick and more acceptable. There is a growing body of evidence on the accuracy of HbA1c as a screening and diagnostic test for GDM. We searched Medline, Embase and Cochrane Library and selected relevant studies. Accuracy data for different thresholds within the final 23 included studies (16 921 women) were pooled using a multiple thresholds model. Summary accuracy indices were estimated by selecting an optimal threshold that optimises either sensitivity or specificity according to different scenarios. SUMMARY: HbA1c is more useful as a specific test at a cut-off of 5.7% (39 mmol/mol) with a false positive rate of 10%, but should be supplemented by a more sensitive test to detect women with GDM

Acceptability and adherence to a Mediterranean diet in the postnatal period to prevent type 2 diabetes in women with gestational diabetes in the UK: a protocol for a single-arm feasibility study (MERIT)

Introduction: Women with gestational diabetes are at increased risk of developing type 2 diabetes later in life. In at-risk general populations, Mediterranean-style diet helps prevent type 2 diabetes. But its effect on postnatal women with a history of gestational diabetes is not known. Prior to a full-scale trial on Mediterranean-style diet in the postnatal period to prevent type 2 diabetes, a feasibility study is required to assess the acceptability of the diet and evaluate the trial processes. Methods and analysis: MEditerranean diet for pReventIon of type 2 diabeTes is a single-arm feasibility study (65 women) with qualitative evaluation of women who have recently given birth and had gestational diabetes. The intervention is a Mediterranean-style diet supplemented with nuts and olive oil, with dietary advice and an action plan. A dedicated Health Coach will interact with participants through an interactive lifestyle App. Women will follow the intervention from 6 to 13 weeks post partum until 1 year post partum. The primary outcomes are rates of recruitment, follow-up, adherence and attrition. The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes, and acceptability of the intervention to participants, and to healthcare professionals delivering the intervention. Feasibility outcomes will be reported using descriptive statistics. Ethics and dissemination: Ethical approval was obtained through the South Central—Berkshire Research Ethics Committee (19/SC/0064). Study findings will be disseminated via publication in peer-reviewed journals, as well as via newsletters made available to participants and members of Katie’s Team (a women’s health patient and public advisory group). Trial registration number: ISRCTN40582975

The Endocrine and Metabolic Characteristics of a Large Bardet-Biedl Syndrome Clinic Population

Context: Bardet-Biedl syndrome (BBS) is a rare autosomal recessive disorder in which previous reports have described obesity and a metabolic syndrome. Objective: We describe the endocrine and metabolic characteristics of a large BBS population compared with matched control subjects. Design: We performed a case-control study. Setting: This study was performed at a hospital clinic. Patients: Study patients had a clinical or genetic diagnosis of BBS. Main Outcome Measurements: Our study determined the prevalence of a metabolic syndrome in our cohort. Results: A total of 152 subjects were studied. Eighty-four (55.3%) were male. Mean (± standard deviation) age was 33.2 ± 1.0 years. Compared with age-, sex-, and body mass index-matched control subjects, fasting glucose and insulin levels were significantly higher in subjects with BBS (glucose: BBS, 5.2 ± 1.2 mmol/L vs control, 4.9 ± 0.9 mmol/L, P = 0.04; insulin: BBS, 24.2 ± 17.0 pmol/L vs control, 14.2 ± 14.8 pmol/L, P < 0.001). Serum triglycerides were significantly higher in subjects with BBS (2.0 ± 1.2 mmol/L) compared with control subjects (1.3 ± 0.8 mmol/L; P < 0.001), but total cholesterol, high-density lipoprotein, and low-density lipoprotein were similar in both groups. Systolic blood pressure was higher in the BBS group (BBS, 135 ± 18 mm Hg vs control subjects, 129 ± 16 mm Hg; P = 0.02). Alanine transaminase was raised in 34 (26.8%) subjects with BBS, compared with five (8.9%) control subjects (P = 0.01). The rate of metabolic syndrome, determined using International Diabetes Federation criteria, was significantly higher in the BBS group (54.3%) compared with control subjects (26% P < 0.001). Twenty-six (19.5%) of male subjects with BBS were hypogonadal (serum testosterone, 9.9 ± 5.3 mmol/L), but significant pituitary abnormalities were uncommon. Subclinical hypothyroidism was present in 24 of 125 (19.4%) patients with BBS, compared with 3 of 65 (4.6%) control subjects (P = 0.01). Conclusions: Insulin resistance and the metabolic syndrome are increased in adult patients with BBS compared with matched control subjects. Increased subclinical hypothyroidism in the BBS cohort needs further investigation

Myo-inositol nutritional supplement for prevention of gestational diabetes (EMmY): a randomised, placebo-controlled, double-blind pilot trial with nested qualitative study.

OBJECTIVES: To determine the feasibility and acceptability of conducting a randomised trial on the effects of myo-inositol in preventing gestational diabetes in high-risk pregnant women. DESIGN: A multicentre, double-blind, placebo-controlled, pilot randomised trial with nested qualitative evaluation. SETTING: Five inner city UK National Health Service hospitals PARTICIPANTS: Multiethnic pregnant women at 12+0 and 15+6 weeks' gestation with risk factors for gestational diabetes. INTERVENTIONS: 2 g of myo-inositol or placebo, both included 200 µg folic acid, twice daily until delivery. PRIMARY OUTCOME MEASURES: Rates of recruitment, randomisation, adherence and follow-up. SECONDARY OUTCOME MEASURES: Glycaemic indices (including homoeostatic model assessment-insulin resistance HOMA-IR), gestational diabetes (diagnosed using oral glucose tolerance test at 28 weeks and by delivery), maternal, perinatal outcomes, acceptability of intervention and costs. RESULTS: Of the 1326 women screened, 58% (773/1326) were potentially eligible, and 27% (205/773) were recruited. We randomised 97% (198/205) of all recruited women (99 each in intervention and placebo arms) and ascertained outcomes in 90% of women (178/198) by delivery. The mean adherence was 52% (SD 44) at 28 weeks' and 34% (SD 41) at 36 weeks' gestation. HOMA-IR and serum insulin levels were lower in the myo-inositol vs placebo arm (mean difference -0.6, 95% CI -1.2 to 0.0 and -2.69, 95% CI -5.26 to -0.18, respectively). The study procedures were acceptable to women and healthcare professionals. Women who perceived themselves at high risk of gestational diabetes were more likely to participate and adhere to the intervention. The powder form of myo-inositol and placebo, along with nausea in pregnancy were key barriers to adherence. CONCLUSIONS: A future trial on myo-inositol versus placebo to prevent gestational diabetes is feasible. The intervention will need to be delivered in a non-powder form to improve adherence. There is a signal for efficacy in reducing insulin resistance in pregnancy with myo-inositol. TRIAL REGISTRATION NUMBER: ISRCTN48872100

The endocrine and metabolic characteristics of a large Bardet-Biedl syndrome clinic population

Bardet-Biedl syndrome (BBS) is a rare autosomal recessive disorder in which previous reports have described obesity and a metabolic syndrome.Describe the endocrine and metabolic characteristics of a large BBS population compared with matched controls.Case-control.Hospital clinic.A clinical/genetic diagnosis of BBS.None.Prevalence of metabolic syndrome.One hundred and fifty-two subjects were studied. Eight-four (55.3%) were male and mean (±SD) age was 33.2±1.0 years. Compared with age, gender and BMI matched controls, fasting glucose and insulin levels were significantly higher in BBS subjects (glucose: BBS: 5.2±1.2mmol/l vs control 4.9±0.9mmol/l, p=0.04; insulin: BBS: 24.2±17.0pmol/l vs control 14.2±14.8pmol/l, p<0.001). Serum triglycerides were significantly higher in BBS subjects (2.0±1.2mmol/l) compared with controls (1.3± 0.8mmol/l p<0.001) but total cholesterol/HDL/LDL were similar in both groups. Systolic blood pressure was higher in the BBS group (BBS 135±18 mmHg vs controls 129±16mmHg (p=0.02). Alanine transaminase (ALT) was raised in 34 (26.8%) BBS subjects, compared to 5 (8.9%) controls (p=0.01). The presence of a metabolic syndrome, using IDF criteria, was significantly higher in the BBS group (54.3%) compared to controls (26% p<0.001). Twenty-six (19.5%) of BBS males were hypogonadal (serum testosterone 9.9±5.3 mmol/l) but significant pituitary abnormalities were uncommon. Subclinical hypothyroidism was present in 24/125 (19.4%) patients with BBS compared with 3/65 (4.6%) controls (p=0.01).Insulin resistance and the metabolic syndrome are increased in adult BBS compared with matched controls. Increased subclinical hypothyroidism in the BBS cohort is a novel finding that needs further investigation

The endocrine and metabolic characteristics of a large Bardet-Biedl syndrome clinic population

Bardet-Biedl syndrome (BBS) is a rare autosomal recessive disorder in which previous reports have described obesity and a metabolic syndrome.Describe the endocrine and metabolic characteristics of a large BBS population compared with matched controls.Case-control.Hospital clinic.A clinical/genetic diagnosis of BBS.None.Prevalence of metabolic syndrome.One hundred and fifty-two subjects were studied. Eight-four (55.3%) were male and mean (±SD) age was 33.2±1.0 years. Compared with age, gender and BMI matched controls, fasting glucose and insulin levels were significantly higher in BBS subjects (glucose: BBS: 5.2±1.2mmol/l vs control 4.9±0.9mmol/l, p=0.04; insulin: BBS: 24.2±17.0pmol/l vs control 14.2±14.8pmol/l, p&lt;0.001). Serum triglycerides were significantly higher in BBS subjects (2.0±1.2mmol/l) compared with controls (1.3± 0.8mmol/l p&lt;0.001) but total cholesterol/HDL/LDL were similar in both groups. Systolic blood pressure was higher in the BBS group (BBS 135±18 mmHg vs controls 129±16mmHg (p=0.02). Alanine transaminase (ALT) was raised in 34 (26.8%) BBS subjects, compared to 5 (8.9%) controls (p=0.01). The presence of a metabolic syndrome, using IDF criteria, was significantly higher in the BBS group (54.3%) compared to controls (26% p&lt;0.001). Twenty-six (19.5%) of BBS males were hypogonadal (serum testosterone 9.9±5.3 mmol/l) but significant pituitary abnormalities were uncommon. Subclinical hypothyroidism was present in 24/125 (19.4%) patients with BBS compared with 3/65 (4.6%) controls (p=0.01).Insulin resistance and the metabolic syndrome are increased in adult BBS compared with matched controls. Increased subclinical hypothyroidism in the BBS cohort is a novel finding that needs further investigation