Efficacy of flash glucose monitoring in pregnant women with poorly controlled pregestational diabetes (FlashMom): A randomized pilot study.

BACKGROUND AND AIMS: Good glycemic control is crucial to reduce the risk of adverse pregnancy outcomes. Our aim was to evaluate the efficacy of Flash Glucose Monitoring (FGM) on glucose control in women with pregestational diabetes. METHODS AND RESULTS: Forty women with inadequately controlled type 1 (T1D, n = 34) and type 2 (T2D, n = 6) diabetes at conception were randomly assigned to two arms: the Flash Glucose group (FG, n = 21) using FGM, and the control group (CG, n = 19) using self-monitoring of blood glucose (SMBG). Glycated hemoglobin (HbA1c, %), time in (TIR), below (TBR) and above (TAR) range, glucose variability as well as the occurrence of maternal and neonatal adverse outcomes, were evaluated. HbA1c decreased significantly (p < 0.01) and similarly (-0.65 ± 0.7 vs. -0.67 ± 0.8 for FG and CG, respectively; p = 0.89) in both groups during pregnancy. HbA1c reduction was positively associated with the number of daily FGM scans (p < 0.01). TBR (12.1 ± 2.0% vs. 19.6 ± 3.9%, p = 0.04) and the mean of the daily serum glucose difference (MODD) index (59.1 ± 5.4 vs. 77.7 ± 4.6, p = 0.02) were significantly lower in FG at second trimester. The rates of perinatal adverse outcomes were not different in the two studied groups. CONCLUSIONS: In women with pregestational diabetes, FGM and SMBG had similar efficacy on glucose control during pregnancy. FGM showed additional advantages in terms of TBR and glucose variability. Achievement of good metabolic results depended on the adequate use of glucose sensor. REGISTRATION: At ClinicalTrials.gov as NCT04666818 on December 14, 2020.

An automated insulin delivery system from pregestational care to postpartum in women with type 1 diabetes. Preliminary experience with telemedicine in 6 patients.

INTRODUCTION: The use of most commercially available automated insulin delivery (AID) systems is off-label in pregnancy. However, an increasing number of women with type 1 diabetes (T1D) use such devices throughout pregnancy and delivery. We analysed the data of six women with T1D from a single centre (Diabetology Outpatient Clinic of District-63/Asl Salerno, Italy) who were able to start and maintain AID therapy with the MiniMed™ 780G (Medtronic, Minneapolis, MN, USA) throughout the pregestational care period, pregnancy, delivery, and postpartum. METHODS: We retrospectively collected data from six patients with T1D who received training and initiation on use of the MiniMed™ 780G and attended follow-up visits throughout pregnancy (these visits were virtual because of the COVID-19 pandemic). All patients maintained their devices in the closed-loop setting throughout pregnancy and during labour and delivery. We analysed data from the pregestational phase to the first 30 days postpartum. RESULTS: All patients achieved the recommended metabolic goals before conception [median time in range (TIR) of 88% for 70-180 mg/dL; median pregnancy-specific TIR 63-140 mg/dL (ps-TIR) of 66% and maintained the ps-TIR until delivery (median ps-TIR 83%). All patients had slightly better metrics during the night than during the day, with a very low time below range of < 63 mg/dL. Optimal glycaemic values were also maintained on the day of labour and delivery (median ps-TIR 92.5%) and in the first 30 days postpartum, with no severe hypoglycaemia. The only neonatal complications were jaundice in one child and an interatrial defect in another child. CONCLUSION: In our well-selected and trained patients, use of the MiniMed™ 780G helped to achieve and maintain ps-metrics from the pregestational period to delivery despite the fact that the algorithm is not set to achieve the ambitious glycaemic values recommended for pregnancy.

Insulin Requirements and Carbohydrate to Insulin Ratio in Normal Weight, Overweight, and Obese Women With Type 1 Diabetes Under Pump Treatment During Pregnancy: A Lesson From Old Technologies.

Aim: The primary aim of this study was to assess insulin requirements and carbohydrate to insulin ratio (CHO/IR) in normal weight, overweight, and obese pregnant women with type 1 diabetes across early, middle, and late pregnancy. Methods: In this multicenter, retrospective, observational study we evaluated 86 of 101 pregnant Caucasian women with type 1 diabetes under pump treatment. The women were trained to calculate CHO/IR daily by dividing CHO grams of every single meal by insulin units injected. Since the purpose of the study was to identify the CHO/IR able to reach the glycemic target, we only selected the CHO/IR obtained when glycemic values were at target. Statistics: SPSS 20. Results: We studied 45 normal weight, 31 overweight, and 10 obese women. Insulin requirements increased throughout pregnancy (p < 0.0001 and <0.001 respectively) in the normal and overweight women, while it remained unchanged in the obese women. Insulin requirements were different between groups when expressed as an absolute value, but not when adjusted for body weight. Breakfast CHO/IR decreased progressively throughout pregnancy in the normal weight women, from 13.3 (9.8-6.7) at the first stage of pregnancy to 6.2 (3.8-8.6) (p = 0.01) at the end stage, and in the overweight women from 8.5 (7.1-12.6) to 5.2 (4.0-8.1) (p = 0.001), while in the obese women it remained stable, moving from 6.0 (5.0-7.9) to 5.1 (4.1-7.4) (p = 0.7). Likewise, lunch and dinner CHO/IR decreased in the normal weight and overweight women (p < 0.03) and not in the obese women. The obese women gained less weight than the others, especially in early pregnancy when they even lost a median of 1.25 (-1 -1.1) kg (p = 0.005). In early pregnancy, we found a correlation between pregestational BMI and insulin requirements (IU/day) or CHO/IR at each meal (p < 0.001 and p = 0.001, respectively). In late pregnancy, a relationship between pre-gestational BMI and CHO/IR change was found (P = 0.004), as well as between weight gain and CHO/IR change (p=0.02). The significance was lost when both variables were included in the multiple regression analysis. There was no difference in pregnancy outcomes except for a higher pre-term delivery rate in the obese women. Conclusion: Pre-gestational BMI and weight gain may play a role in determining CHO/IR during pregnancy in women with type 1 diabetes under pump treatment.

Screening of postpartum diabetes in women with gestational diabetes: high-risk subgroups and areas for improvements-the STRONG observational study.

AIMS: To assess the proportion of women with gestational diabetes (GDM) by performing postpartum Oral Glucose Tolerance Test (OGTT) and to identify GDM phenotypes at high-risk of postpartum dysglycemia (PPD). METHODS: Observational, retrospective, multicenter study involving consecutive GDM women. Recursive partitioning (RECPAM) analysis was used to identify distinct and homogeneous subgroups of women at different PPD risk. RESULTS: From a sample of 2,736 women, OGTT was performed in 941 (34.4%) women, of whom 217 (23.0%) developed PPD. Insulin-treated women having family history of diabetes represented the subgroup with the highest PPD risk (OR 5.57, 95% CI 3.60-8.63) compared to the reference class (women on diet with pre-pregnancy BMI < = 28.1 kg/m2). Insulin-treated women without family diabetes history and women on diet with pre-pregnancy BMI > 28.1 kg/m2 showed a two-fold PPD risk. Previous GDM and socioeconomic status represent additional predictors. Fasting more than post-prandial glycemia plays a predictive role, with values of 81-87 mg/dl (4.5-4.8 mmol/l) (lower than the current diagnostic GDM threshold) being associated with PPD risk. CONCLUSIONS: Increasing compliance to postpartum OGTT to prevent/delay PPD is a priority. Easily available characteristics identify subgroups of women more likely to benefit from preventive strategies. Fasting BG values during pregnancy lower than those usually considered deserve attention.

The risk stratification of adverse neonatal outcomes in women with gestational diabetes (STRONG) study.

AIMS: To assess the risk of adverse neonatal outcomes in women with gestational diabetes (GDM) by identifying subgroups of women at higher risk to recognize the characteristics most associated with an excess of risk. METHODS: Observational, retrospective, multicenter study involving consecutive women with GDM. To identify distinct and homogeneous subgroups of women at a higher risk, the RECursive Partitioning and AMalgamation (RECPAM) method was used. Overall, 2736 pregnancies complicated by GDM were analyzed. The main outcome measure was the occurrence of adverse neonatal outcomes in pregnancies complicated by GDM. RESULTS: Among study participants (median age 36.8 years, pre-gestational BMI 24.8 kg/m2), six miscarriages, one neonatal death, but no maternal death was recorded. The occurrence of the cumulative adverse outcome (OR 2.48, 95% CI 1.59-3.87), large for gestational age (OR 3.99, 95% CI 2.40-6.63), fetal malformation (OR 2.66, 95% CI 1.00-7.18), and respiratory distress (OR 4.33, 95% CI 1.33-14.12) was associated with previous macrosomia. Large for gestational age was also associated with obesity (OR 1.46, 95% CI 1.00-2.15). Small for gestational age was associated with first trimester glucose levels (OR 1.96, 95% CI 1.04-3.69). Neonatal hypoglycemia was associated with overweight (OR 1.52, 95% CI 1.02-2.27) and obesity (OR 1.62, 95% CI 1.04-2.51). The RECPAM analysis identified high-risk subgroups mainly characterized by high pre-pregnancy BMI (OR 1.68, 95% CI 1.21-2.33 for obese; OR 1.38 95% CI 1.03-1.87 for overweight). CONCLUSIONS: A deep investigation on the factors associated with adverse neonatal outcomes requires a risk stratification. In particular, great attention must be paid to the prevention and treatment of obesity.

A Study of the Carbohydrate-to-Insulin Ratio in Pregnant Women with Type 1 Diabetes on Pump Treatment.

AIM: The aim of this study was to assess carbohydrate (CHO)-to-insulin ratio (CHO/IR) values in pregnant women with type 1 diabetes and to describe differences in CHO/IR across each week of pregnancy. MATERIALS AND METHODS: This was a multicenter, retrospective, observational study (2006-2012) of 101 white pregnant women with a mean age of 32 (range, 18-43) years who had type 1 diabetes and were under continuous subcutaneous insulin infusion (CSII) therapy. These patients had the following characteristics: type 1 diabetes duration was 1 year (range, 1-31 years), the pregestational glycosylated hemoglobin level was 6.9% (range, 6.8-12.1%), the median weight gain during pregnancy was 14 kg (-3; 25 kg), with delivery at 37 weeks (range, 30-40 weeks), and the child had a birth weight of 3.530 kg (range, 1.480-5.250 kg). The CHO/IR was measured by dividing the CHO (in g) of each meal by insulin unit injected to acquire and maintain the following glycemic targets: fasting <90 mg/dL and 1-h postprandial <130 mg/dL. Simultaneously, CHO/IR indices were calculated through 500/total daily doses of insulin and 300/total daily doses of insulin. Education and management before and during pregnancy were in agreement with Italian Association of Dietitians, Association of Medical Diabetologists, and Italian Society of Diabetology recommendations. Data were analyzed using SPSS software (version 20.0; SPSS, Inc., Chicago, IL). RESULTS: The CHO/IR decreased on average from 9.6 (5-18) to 5.4 (2.3-8) at breakfast, from 10 (3.5-16) to 8.4 (3.0-17.8) at lunch, and from 12.5 (8-20) to 6.1 (4.2-12) at dinner. The CHO/IR calculated using the "500 rule" decreased from 14.3 (10-20.3) to 8.6 (4.1-15.9). Using the "300 rule," the ratios decreased from 8.5 (6-12.1) to 5.2 (2.4-9.5). The bivariate correlation between the values calculated more appropriate values using the "300 rule" for breakfast and the "500 rule" for lunch and dinner across all weeks of pregnancy. CONCLUSIONS: CHO/IR reduction in pregnancy is likely due to an increase in insulin resistance.

Level of implementation of guidelines on screening and diagnosis of gestational diabetes: A national survey.

AIMS: To describe the degree of diffusion and acceptance of national guideline on screening and diagnosis of gestational diabetes (GDM) among Italian diabetes centers and to detect possible areas for benchmarking. METHODS: In 2013 the Italian Diabetes in Pregnancy Study Group structured a national survey, focused on GDM screening and diagnostic procedures, that was administered to diabetologists. RESULTS: Overall, 122 diabetologists of 122 different diabetes centers (21.7% territorial, 78.3% hospital/University) completed the questionnaire. All respondents declared to execute a 75 g-oral glucose tolerance test (OGTT) as diagnostic test. Almost one in five centers preferred a universal screening procedure, the others executing a selective risk factors-based screening. In patients at high risk for GDM the OGTT was performed at 16-18 weeks' gestation in 84.0% of the cases; only 6.5% of respondents preferred to execute it as soon as possible; and 9.5% used to wait until 24-28 weeks' gestation. In the case of fasting plasma glucose (FPG) ≥ 5.1 mmol/l (92 mg/dl), two third of respondents used to proceed with the execution of the complete diagnostic OGTT, the others considering sufficient the FPG value for the diagnosis. CONCLUSIONS: Good level of reception of national recommendations was documented. The diagnostic procedure was generally accepted and applied. Some criticisms were specifically linked to the choice of universal or risk factor-based screening procedure, and to the right time for executing the OGTT in women at high risk.

Experiences of continuous subcutaneous insulin infusion in pregnant women with type 1 diabetes during delivery from four Italian centers: a retrospective observational study.

OBJECTIVES: An optimized metabolic control during delivery is mandatory to prevent maternal-neonatal complications. The primary aim of this study was to evaluate the efficacy and safety of continuous subcutaneous insulin infusion (CSII) during delivery in pregnant women with type 1 diabetes. The secondary aim was to assess the impact of real-time continuous glucose monitoring (RT-CGM) added to CSII versus CSII alone. RESEARCH DESIGN AND METHODS: This was a multicenter observational retrospective study. A standardized protocol, to use CSII throughout pregnancy and delivery, foresaw three different insulin basal rates according to blood glucose level: profile A, the last basal rate in use; profile B, preventive 50% reduction of the last basal rate in use; and profile C, 0.1-0.2 U/h for blood glucose level <70 mg/dL, activated just before anesthesia or at the beginning of active labor. An alternative intravenous protocol (IVP) was given in case of complications and relevant metabolic deterioration. Blood glucose in the target range (70-140 mg/dL) throughout delivery and percentage of activation of the IVP were primary outcomes. RESULTS: Sixty-five pregnant women with diabetes included in the study (56-86% cesarean section; 9-14% spontaneous/stimulated vaginal delivery). Mean blood glucose level was 102 ± 31 mg/dL at 0 min, 109 ± 42 mg/dL at 30 min, 120 ± 48 mg/dL at 60 min, and 99 ± 34 mg/dL at 24 h. Mean basal rate during delivery was 0.6 ± 0.4 U/h (profile B). Mean capillary blood glucose (CBG) level was lower in the RT-CGM group relative to the CSII-alone group: 80 ± 14 mg/dL versus 111 ± 32 mg/dL at 0 min (P<0.01), 79 ± 11 mg/dL versus 109 ± 42 mg/dL at 30 min (P<0.02), and 98 ± 20 mg/dL versus 125 ± 51 mg/dL at 60 min (difference not significant). Eleven newborns experienced transient neonatal hypoglycemia. None of the women switched to IVP. No major differences were observed according to delivery procedure. CONCLUSIONS: CSII is possible and safe in different types of delivery in selected and educated women. RT-CGM helps to obtain better outcomes in terms of maternal peripartum CBG level.