Randomized Trial of Assisted Hybrid Closed-Loop Therapy Versus Sensor-Augmented Pump Therapy in Pregnancy.

Objective: Examine gestational safety, glycemic and health outcomes, of a hybrid closed-loop (HCL) system without pregnancy-specific glucose targets. Research Design: This was a pilot feasibility investigator-initiated, two-site, single-blind, randomized controlled trial of sensor-augmented pump therapy (SAPT) versus HCL therapy in type 1 diabetes pregnancies. Participants were enrolled in the first trimester and randomized at 14-18 weeks of gestation and used SAPT or HCL until 4-6 weeks postpartum. We compared continuous glucose monitoring (CGM) metrics, severe hypoglycemia (SH), diabetic ketoacidosis (DKA), adverse skin reactions, and pregnancy outcomes between groups. Results: Baseline characteristics were similar between groups (n = 11 HCL and n = 12 SAPT). There was no SH or DKA episode after randomization. Time spent <54 mg/dL did not differ between groups. Time spent <63 mg/dL decreased in both groups, significantly in the HCL group (3.5% [1.3% standard error] second trimester and 2.8% [1.3%] third trimester vs. 7.9% [1.3%] run-in phase, P < 0.05 for both). Mean sensor glucose was lower with SAPT compared to HCL therapy in the third trimester (119 [4] mg/dL SAPT vs. 132 [4] mg/dL HCL, P < 0.05). Third trimester time-in-range (TIR; 63-140 mg/dL) increased with SAPT (68.2% [3.1%] vs. 64.3% [3.1%] run-in phase, P < 0.05). Gestational health outcomes did not differ between groups. The HCL group used assistive techniques, such as fake carbohydrate boluses and exiting HCL overnight. Conclusions: CGM within group differences were seen for time <63 mg/dL favoring HCL therapy and TIR favoring SAPT (third trimester vs. baseline). Safety and adverse pregnancy outcomes were similar between groups.

Glycemic variability and indices of glycemic control among pregnant women with type 1 diabetes (T1D) based on the use of continuous glucose monitoring share technology.

BACKGROUND: Pregnancies complicated by type 1 diabetes (T1D) experience high levels of glycemic variability, which may be associated with adverse maternal and neonatal outcomes. Therefore, strategies that help pregnant women with T1D manage their glycemic control are of great interest. METHODS: We examined associations with or without remote monitoring of Continuous Glucose Monitor (CGM) data by friends and family with indices of glycemic control and glycemic variability during pregnancies complicated by T1D in a pilot non-randomized trial (n = 28). During preconception or the first trimester, participants were placed in one of two groups based on device compatibility: (1) CGM Alone (n = 13): women without iPhone, iPad or iPod Touch; or (2) CGM Share (n = 15): women with iPhone, iPad, or iPod Touch and followers with devices compatible for data viewing. Linear mixed models were used to compare indices of glycemic control and glycemic variability over time between groups. RESULTS: Participants using CGM Share had lower estimated HbA1c levels over time (p = .028), glucose management index (p = .041), and fewer glucose excursions >200 mg/dL in each trimester (p = .022) compared to those using CGM Alone. Participants using CGM Alone had higher high blood glucose index (p = .020), mean area under the curve (p = .026), and standard deviation (p = .046) compared to those using CGM Share. Other measures of glycemic variability did not differ between groups. CONCLUSION: In this non-randomized pilot study, use of CGM Share was associated with improvements in several indices of glycemic control and glycemic variability.

Relationship Between Time-in-Range, HbA1c, and the Glucose Management Indicator in Pregnancies Complicated by Type 1 Diabetes.

Objective: We aimed to evaluate relationships between time-in-range (TIR 63-140 mg/dL), glycated hemoglobin A1c (HbA1c) level, and the glucose management indicator (GMI) in pregnant women with type 1 diabetes. Research Design and Methods: Continuous glucose monitoring (CGM) data from 27 women with type 1 diabetes were collected prospectively throughout pregnancy. Up to 90-days of CGM data were correlated with point-of-care HbA1c levels measured in the clinic at each trimester. GMI levels were calculated using a published regression formula. Liner models were used to compare TIR, HbA1c, and GMI by each trimester. Results: There was a significant negative correlation between TIR and HbA1c; each 10% increase in TIR was associated with a 0.3% reduction in HbA1c. The correlation between TIR and HbA1c was stronger (r = -0.8) during the second and third trimesters than during the first trimester (r = -0.4). There was good correlation between TIR and GMI during each trimester (r = 0.9 for each trimester). The relationship between GMI and HbA1c especially during second (r = 0.8) and third trimesters (r = 0.8) was strong. Conclusion: In the first trimester, the correlation between HbA1c level and TIR was relatively small, while that of TIR and GMI was very strong, thus GMI may better reflect glycemic control than HbA1c in early pregnancy. Each 10% increase in TIR was associated with a 0.3% reduction in HbA1c throughout pregnancy, which was lower than other published studies in nonpregnant populations reporting a 0.5%-0.8% reduction in HbA1c. Further studies are needed to understand the relationship between TIR and GMI and how GMI may affect maternal and fetal complications. Clinical Trial Registration number: NCT02556554.

Exploratory Analysis of Glycemic Control and Variability Over Gestation Among Pregnant Women with Type 1 Diabetes.

In exploratory analyses, we evaluated glycemic variability (GV) and gestational outcomes in pregnant women (n = 28) with type 1 diabetes (T1D). Gestational age at delivery was higher for women with lower glycemic measures, including estimated HbA1c (eHbA1c) (0.14% decrease in HbA1c per 1-week greater gestational age, P = 0.0035), mean sensor glucose (-3.9 mg/dL P = 0.0039), time spent >140 mg/dL (-3.1%, P = 0.0029), and higher time in range (TIR) of 63-140 mg/dL (3.2%, P = 0.0029). Third trimester measured HbA1c was significantly associated with gestational age at delivery (P = 0.0081). Preeclampsia was associated with less TIR in first (50.5% vs. 69.9%, P = 0.0034) and second trimesters (47.1% vs. 66.7%, P = 0.0025), but not with measured HbA1c. There were significant differences in other markers of GV (continuous overall net glycemic action, high blood glucose index, J-index, mean amplitude of glycemic excursions) with infant birth weight and gestational age at delivery. Thus, multiple markers of glycemia and GV were associated with gestational health outcomes in T1D pregnancies in this pilot study. Clinical Trial Registration number: NCT02556554.

Continuous glucose monitor use with and without remote monitoring in pregnant women with type 1 diabetes: A pilot study.

BACKGROUND: To examine whether continuous glucose monitoring (CGM) with remote monitoring by followers (family/friends) changes glucose management, follower interventions, and health outcomes compared to CGM alone in pregnant women with diabetes. METHODS: We prospectively stratified first trimester pregnant women with Type 1 Diabetes to CGM Share (remote monitoring) or CGM Alone. We enrolled a main follower per woman. We retrospectively acquired data for pregnant women who did not use CGM (no CGM). We compared hemoglobin A1c (HbA1c) between groups. We compared sensor glucose, follower interventions, and gestational outcomes between CGM Alone and CGM Share. Longitudinal mixed effects models were used for analyses of changes in outcomes over time. RESULTS: HbA1c decreased in all groups throughout pregnancy and was significantly lower over time in women using CGM Share (n = 15) compared to CGM Alone (n = 13) or no CGM (n = 8) (p = 0.0042). CGM Share users had lower median sensor glucose levels (p = 0.0331) and percent time spent >180 mg/dL (p = 0.0228) across pregnancy. There were no significant differences in maternal and fetal outcomes between groups. CGM Share followers had more alerts for hypoglycemia, but did fewer interventions. CONCLUSIONS: In this small pilot study, use of CGM with remote monitoring improved some glycemic metrics in pregnant women with diabetes.

CGM, Pregnancy, and Remote Monitoring.

The glycemic goals of pregnancy are very narrow to reduce excess risks for numerous maternal and fetal complications. Continuous glucose monitors (CGMs) may help women achieve glucose goals and reduce hypoglycemia. CGM use has been found to be safe and effective in pregnancies associated with diabetes. CGM use can accurately identify glycemic patterns among women with and without diabetes in pregnancy. The data on the effects of CGM use on maternal and fetal outcomes are conflicting. Using CGMs in conjunction with continuous subcutaneous insulin infusion therapy in pregnancies complicated by diabetes may improve outcomes. There are limitations of CGM use that affect patients in and outside of pregnancy, as well as specific barriers that only affect pregnant women. Of importance, CGM use does not replace standard clinical care, but may be used an adjunctive tool in pregnancy. CGM remote monitoring in pregnancy is an understudied field. In this study, we review the studies on CGM use in pregnancy.

Using technology to advance type 1 diabetes care among women during the reproductive years and in pregnancy.

The prevalence of diabetes is increasing globally. Technology to improve care among individuals with diabetes is constantly being developed. Women living with Type 1 Diabetes Mellitus (T1DM) have unique challenges affecting their glucose control relating to menstrual cycles, pregnancy, and menopause. The purpose of this review is to examine the literature related to the use of technology to help women with T1DM manage their diabetes during the reproductive years, pregnancy, and beyond. Continuous subcutaneous insulin infusion (CSII) therapy can provider equivalent or better glucose control when compared with multiple daily injections (MDI), with less hypoglycemia, diabetic ketoacidosis, and weight gain. The CSII therapy has features that could help improve glucose control over the menstrual cycle, menopause, and pregnancy, although the most studied of these stages is pregnancy. Continuous glucose monitoring (CGM) can be combined with any insulin delivery system (MDI or CSII) to provide data on glucose values every few minutes and show glucose trends over time. CGM introduction can highlight glucose variability for women with T1DM, may be beneficial during pregnancy, and can reduce hypoglycemia. Sensor-augmented pump therapy and hybrid artificial pancreas (closed-loop) systems are promising tools that improve outcomes among individuals with diabetes. The use of modern technology to improve glucose and metabolic control among menopausal women with diabetes has not been well studied. Internet and phone-based technologies are emerging as important tools that may help with diabetes self-care for women living with diabetes.