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

ABSTRACT: 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.

SUBMITTER: Polsky S

PROVIDER: S-EPMC7162510 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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

Polsky Sarit S Garcetti Rachel R Pyle Laura L Joshee Prakriti P Demmitt Jamie K JK Snell-Bergeon Janet K JK

PloS one 20200416 4

<h4>Background</h4>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.<h4>Methods</h4>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 u ...[more]

PMID: 32298269

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Project description:AIMS/HYPOTHESIS:The aim of this study was to analyse patterns of continuous glucose monitoring (CGM) data for associations with large for gestational age (LGA) infants and an adverse neonatal composite outcome (NCO) in pregnancies in women with type 1 diabetes. METHODS:This was an observational cohort study of 186 pregnant women with type 1 diabetes in Sweden. The interstitial glucose readings from 92 real-time (rt) CGM and 94 intermittently viewed (i) CGM devices were used to calculate mean glucose, SD, CV%, time spent in target range (3.5-7.8 mmol/l), mean amplitude of glucose excursions and also high and low blood glucose indices (HBGI and LBGI, respectively). Electronic records provided information on maternal demographics and neonatal outcomes. Associations between CGM indices and neonatal outcomes were analysed by stepwise logistic regression analysis adjusted for confounders. RESULTS:The number of infants born LGA was similar in rtCGM and iCGM users (52% vs 53%). In the combined group, elevated mean glucose levels in the second and the third trimester were significantly associated with LGA (OR 1.53, 95% CI 1.12, 2.08, and OR 1.57, 95% CI 1.12, 2.19, respectively). Furthermore, a high percentage of time in target in the second and the third trimester was associated with lower risk of LGA (OR 0.96, 95% CI 0.94, 0.99 and OR 0.97, 95% CI 0.95, 1.00, respectively). The same associations were found for mean glucose and for time in target and the risk of NCO in all trimesters. SD was significantly associated with LGA in the second trimester and with NCO in the third trimester. Glucose patterns did not differ between rtCGM and iCGM users except that rtCGM users had lower LBGI and spent less time below target. CONCLUSIONS/INTERPRETATION:Higher mean glucose levels, higher SD and less time in target range were associated with increased risk of LGA and NCO. Despite the use of CGM throughout pregnancy, the day-to-day glucose control was not optimal and the incidence of LGA remained high.

Project description:DisclaimerIn an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.PurposeInpatient diabetes management involves frequent assessment of glucose levels for treatment decisions. Here we describe a program for inpatient real-time continuous glucose monitoring (rtCGM) at a community hospital and the accuracy of rtCGM-based glucose estimates.MethodsAdult inpatients with preexisting diabetes managed with intensive insulin therapy and a diagnosis of coronavirus disease 2019 (COVID-19) were monitored via rtCGM for safety. An rtCGM system transmitted glucose concentration and trending information at 5-minute intervals to nearby smartphones, which relayed the data to a centralized monitoring station. Hypoglycemia alerts were triggered by rtCGM values of ≤85 mg/dL, but rtCGM data were otherwise not used in management decisions; insulin dosing adjustments were based on blood glucose values measured via blood sampling. Accuracy was evaluated retrospectively by comparing rtCGM values to contemporaneous point-of-care (POC) blood glucose values.ResultsA total of 238 pairs of rtCGM and POC data points from 10 patients showed an overall mean absolute relative difference (MARD) of 10.3%. Clarke error grid analysis showed 99.2% of points in the clinically acceptable range, and surveillance error grid analysis showed 89.1% of points in the lowest risk category. It was determined that for 25% of the rtCGM values, discordances in rtCGM and POC values would likely have resulted in different insulin doses. Insulin dose recommendations based on rtCGM values differed by 1 to 3 units from POC-based recommendations.ConclusionrtCGM for inpatient diabetes monitoring is feasible. Evaluation of individual rtCGM-POC paired values suggested that using rtCGM data for management decisions poses minimal risks to patients. Further studies to establish the safety and cost implications of using rtCGM data for inpatient diabetes management decisions are warranted.

Project description:BackgroundGestational Diabetes Mellitus (GDM) incidence and adverse outcomes have increased globally. The validity of the oral glucose tolerance test (OGTT) for GDM diagnosis has long been questioned, with no suitable substitute reported yet. Continuous Glucose Monitoring (CGM) is potentially a more acceptable and comprehensive test. The aim of this study was to assess the Freestyle Libre Pro 2 acceptability as a diagnostic test for GDM, then triangulating its results with OGTT results as well as risk factors and sonographic features of GDM.MethodsWomen wore the CGM device for 7 days at 24-28 weeks, undergoing the OGTT before CGM removal. CGM/OGTT acceptability as well as GDM risk factors evaluation occurred via three online surveys. CGM distribution/variability/time in range parameters, combined in a CGM Score of Variability (CGMSV), were triangulated with OGTT results and a risk-factor-based Total Risk Score (TRS). In a subgroup, GDM ultrasound features (as modified Ultrasound Gestational Diabetes Score - m-UGDS) were also incorporated.ResultsOf 107 women recruited, 87 (81%) were included: 74 (85%) with negative OGTT (NGT) and 13 (15%) positive (GDM). No significant difference was found between NGT and GDM in terms of demographics (apart from family history of diabetes mellitus), CGM parameters and perinatal outcomes. Women considered CGM significantly more acceptable than OGTT (81% versus 27% rating 5/5, p < 0.001). Of the 55 NGT with triangulation data, 28 were considered 'true negative' (TRS concordant with OGTT and CGMSV): of these 4/5 evaluated at ultrasound had m-UGDS below the cut-off. Five women were considered 'false negative' (negative OGTT with both TRS and CGMSV above the respective cut-offs). Triangulation identified also six 'false positive' women (positive OGTT but TRS and CGM both below the cut-offs). Only one woman for each of the last two categories had m-UGDS evaluated, with discordant results.ConclusionsCGM represents a more acceptable alternative for GDM diagnosis to the OGTT. CGM triangulation analysis suggests OGTT screening may result in both false positives and negatives. Further research including larger cohorts of patients, and additional triangulation elements (such as GDM biomarkers/outcomes and expanded m-UGDS) is needed to explore CGM potential for GDM diagnosis.

Dataset Information

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

Publications

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

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