Rosemary C. Temple

Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial

Objective To evaluate the effectiveness of continuous glucose monitoring during pregnancy on maternal glycaemic control, infant birth weight, and risk of macrosomia in women with type 1 and type 2 diabetes. Design Prospective, open label randomised controlled trial. Setting Two secondary care multidisciplinary obstetric clinics for diabetes in the United Kingdom. Participants 71 women with type 1 diabetes (n=46) or type 2 diabetes (n=25) allocated to antenatal care plus continuous glucose monitoring (n=38) or to standard antenatal care (n=33). Intervention Continuous glucose monitoring was used as an educational tool to inform shared decision making and future therapeutic changes at intervals of 4-6 weeks during pregnancy. All other aspects of antenatal care were equal between the groups. Main outcome measures The primary outcome was maternal glycaemic control during the second and third trimesters from measurements of HbA1c levels every four weeks. Secondary outcomes were birth weight and risk of macrosomia using birthweight standard deviation scores and customised birthweight centiles. Statistical analyses were done on an intention to treat basis. Results Women randomised to continuous glucose monitoring had lower mean HbA1c levels from 32 to 36 weeks’ gestation compared with women randomised to standard antenatal care: 5.8% (SD 0.6) v 6.4% (SD 0.7). Compared with infants of mothers in the control arm those of mothers in the intervention arm had decreased mean birthweight standard deviation scores (0.9 v 1.6; effect size 0.7 SD, 95% confidence interval 0.0 to 1.3), decreased median customised birthweight centiles (69% v 93%), and a reduced risk of macrosomia (odds ratio 0.36, 95% confidence interval 0.13 to 0.98). Conclusion Continuous glucose monitoring during pregnancy is associated with improved glycaemic control in the third trimester, lower birth weight, and reduced risk of macrosomia. Trial registration Current Controlled Trials ISRCTN84461581.

Association between outcome of pregnancy and glycaemic control in early pregnancy in type 1 diabetes: population based study

Recent studies of pregnancy in women in the United Kingdom with type 1 diabetes have shown a fourfold to tenfold increased risk of congenital malformation and a fivefold increased risk of perinatal mortality compared with non-diabetic women. 1 2 These studies used different measures of glycaemic control (concentrations of glycated haemoglobin and fructosamine) both within and between centres so no conclusions were reached about the relation between outcome and glycaemic control. We conducted a population study examining the relation between glycaemic control in early pregnancy and outcome of pregnancy in women with type 1 diabetes. This observational study was carried out in a single centre in Norwich from January 1991 to December 2000. The resident population is 510 000 and mainly white. We defined adverse pregnancy outcome as spontaneous abortion (first or second trimester), major congenital malformation (potentially life threatening …

The pregnancies of women with Type 2 diabetes: poor outcomes but opportunities for improvement

Aim  To compare the outcomes of Type 1 and Type 2 diabetic pregnancies and identify risk factors for poor outcome of Type 2 pregnancies

Effectiveness of a Regional Prepregnancy Care Program in Women With Type 1 and Type 2 Diabetes: Benefits beyond glycemic control

OBJECTIVE To implement and evaluate a regional prepregnancy care program in women with type 1 and type 2 diabetes. RESEARCH DESIGN AND METHODS Prepregnancy care was promoted among patients and health professionals and delivered across 10 regional maternity units. A prospective cohort study of 680 pregnancies in women with type 1 and type 2 diabetes was performed. Primary outcomes were adverse pregnancy outcome (congenital malformation, stillbirth, or neonatal death), congenital malformation, and indicators of pregnancy preparation (5 mg folic acid, gestational age, and A1C). Comparisons were made with a historical cohort (n = 613 pregnancies) from the same units during 1999–2004. RESULTS A total of 181 (27%) women attended, and 499 women (73%) did not attend prepregnancy care. Women with prepregnancy care presented earlier (6.7 vs. 7.7 weeks; P < 0.001), were more likely to take 5 mg preconception folic acid (88.2 vs. 26.7%; P < 0.0001) and had lower A1C levels (A1C 6.9 vs. 7.6%; P < 0.0001). They had fewer adverse pregnancy outcomes (1.3 vs. 7.8%; P = 0.009). Multivariate logistic regression confirmed that in addition to glycemic control, lack of prepregnancy care was independently associated with adverse outcome (odds ratio 0.2 [95% CI 0.05–0.89]; P = 0.03). Compared with 1999–2004, folic acid supplementation increased (40.7 vs. 32.5%; P = 0.006) and congenital malformations decreased (4.3 vs. 7.3%; P = 0.04). CONCLUSIONS Regional prepregnancy care was associated with improved pregnancy preparation and reduced risk of adverse pregnancy outcome in type 1 and type 2 diabetes. Prepregnancy care had benefits beyond improved glycemic control and was a stronger predictor of pregnancy outcome than maternal obesity, ethnicity, or social disadvantage.

Closed-Loop Insulin Delivery During Pregnancy Complicated by Type 1 Diabetes

OBJECTIVE This study evaluated closed-loop insulin delivery with a model predictive control (MPC) algorithm during early (12–16 weeks) and late gestation (28–32 weeks) in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS Ten women with type 1 diabetes (age 31 years, diabetes duration 19 years, BMI 24.1 kg/m2, booking A1C 6.9%) were studied over 24 h during early (14.8 weeks) and late pregnancy (28.0 weeks). A nurse adjusted the basal insulin infusion rate from continuous glucose measurements (CGM), fed into the MPC algorithm every 15 min. Mean glucose and time spent in target (63–140 mg/dL), hyperglycemic (>140 to ≥180 mg/dL), and hypoglycemic (<63 to ≤50 mg/dL) were calculated using plasma and sensor glucose measurements. Linear mixed-effects models were used to compare glucose control during early and late gestation. RESULTS During closed-loop insulin delivery, median (interquartile range) plasma glucose levels were 117 (100.8–154.8) mg/dL in early and 126 (109.8–140.4) mg/dL in late gestation (P = 0.72). The overnight mean (interquartile range) plasma glucose time in target was 84% (50–100%) in early and 100% (94–100%) in late pregnancy (P = 0.09). Overnight mean (interquartile range) time spent hyperglycemic (>140 mg/dL) was 7% (0–40%) in early and 0% (0–6%) in late pregnancy (P = 0.25) and hypoglycemic (<63 mg/dL) was 0% (0–3%) and 0% (0–0%), respectively (P = 0.18). Postprandial glucose control, glucose variability, insulin infusion rates, and CGM sensor accuracy were no different in early or late pregnancy. CONCLUSIONS MPC algorithm performance was maintained throughout pregnancy, suggesting that overnight closed-loop insulin delivery could be used safely during pregnancy. More work is needed to achieve optimal postprandial glucose control.

Trends in bed occupancy for inpatients with diabetes before and after the introduction of a diabetes inpatient specialist nurse service.

Aims  To compare diabetes bed occupancy and inpatient length of stay, before and after the introduction of a dedicated diabetes inpatient specialist nurse (DISN) service in a large UK Hospital.

Obstetric and perinatal outcomes in pregnancies complicated by Type 1 and Type 2 diabetes:influences of glycaemic control, obesity and social disadvantage

Diabet. Med. 28, 1060–1067 (2011)

Personal experiences of women with diabetes who do not attend pre-pregnancy care

Diabet. Med. 27, 92–100 (2010)

Closed-Loop Insulin Delivery during Pregnancy in Women with Type 1 Diabetes

BACKGROUND In patients with type 1 diabetes who are not pregnant, closed-loop (automated) insulin delivery can provide better glycemic control than sensor-augmented pump therapy, but data are lacking on the efficacy, safety, and feasibility of closed-loop therapy during pregnancy. METHODS We performed an open-label, randomized, crossover study comparing overnight closed-loop therapy with sensor-augmented pump therapy, followed by a continuation phase in which the closed-loop system was used day and night. Sixteen pregnant women with type 1 diabetes completed 4 weeks of closed-loop pump therapy (intervention) and sensor-augmented pump therapy (control) in random order. During the continuation phase, 14 of the participants used the closed-loop system day and night until delivery. The primary outcome was the percentage of time that overnight glucose levels were within the target range (63 to 140 mg per deciliter [3.5 to 7.8 mmol per liter]). RESULTS The percentage of time that overnight glucose levels were in the target range was higher during closed-loop therapy than during control therapy (74.7% vs. 59.5%; absolute difference, 15.2 percentage points; 95% confidence interval, 6.1 to 24.2; P=0.002). The overnight mean glucose level was lower during closed-loop therapy than during control therapy (119 vs. 133 mg per deciliter [6.6 vs. 7.4 mmol per liter], P=0.009). There were no significant differences between closed-loop and control therapy in the percentage of time in which glucose levels were below the target range (1.3% and 1.9%, respectively; P=0.28), in insulin doses, or in adverse-event rates. During the continuation phase (up to 14.6 additional weeks, including antenatal hospitalizations, labor, and delivery), glucose levels were in the target range 68.7% of the time; the mean glucose level was 126 mg per deciliter (7.0 mmol per liter). No episodes of severe hypoglycemia requiring third-party assistance occurred during either phase. CONCLUSIONS Overnight closed-loop therapy resulted in better glucose control than sensor-augmented pump therapy in pregnant women with type 1 diabetes. Women receiving day-and-night closed-loop therapy maintained glycemic control during a high proportion of the time in a period that encompassed antenatal hospital admission, labor, and delivery. (Funded by the National Institute for Health Research and others; Current Controlled Trials number, ISRCTN71510001.).

Type 2 diabetes in pregnancy - An increasing problem.

The worldwide epidemic in type 2 diabetes has been associated with an increased diagnosis in young adults. This has lead to a rapid rise in the number of pregnancies complicated by type 2 diabetes. Studies have shown risk of serious adverse outcome, including congenital malformation and perinatal mortality, is the same, or increased, in type 2 diabetes compared to type 1 diabetes. Despite improved glycaemic control in type 2 diabetes compared to type 1 diabetes, rates of perinatal morbidity, including preterm birth and macrosomia, appear to be similar. Risk factors associated with poor pregnancy outcome in women with type 2 diabetes include obesity, ethnicity and poor pregnancy preparation. This review will cover practical aspects of management of type 2 diabetes before, during and after pregnancy, including prepregnancy care, safety of oral hypoglycaemic agents, glycaemic management during labour, and choice of effective contraception.