Potentialities of modern glucose monitoring devices during pregnancy
* Impact factor according to the SCIENCE INDEX 2020
F.O. Ushanova, T.Yu. Demidova
Pirogov Russian National Research Medical University, Moscow, Russian Federation
Currently, the management of pregnant women with carbohydrate metabolism disorders is challenging due to the high risk of unfavorable events both for the mother and the child even in insignificant deviations from the target value. In addition to the conventional methods of self-monitoring, continuous glucose monitoring (CGM) is an important tool to control diabetes. CGM in pregnant women provides the detailed information on the type and trends of the changes in blood glucose levels and the fluctuations of glucose levels and also identifies the episodes of latent nocturnal hypoglycemia and postprandial hyperglycemia. The analysis of CGM data allows for correcting insulin therapy, taking a decision on its initiation, and modifying diet and exercise plan. Multiple studies demonstrate the efficacy of CGM in terms of compensating manifest diabetes. As to gestational diabetes, the eligibility of modern glucose monitoring technologies for the prevention of various complications is st ill controversial. Further studies on the potential use of these devices in gestational diabetes could provide a basis for increasing their application in routine clinical practice. This will improve the management of pregnant women with carbohydrate metabolism disorders.
Keywords: diabetes, gestational diabetes, continuous glucose monitoring, flash monitoring, pregnancy, macrosomia, self-monitoring.
For citation: Ushanova F.O., Demidova T.Yu. Potentialities of modern glucose monitoring devices during pregnancy. Russian Medical Inquiry. 2020;4(6):352–357. DOI: 10.32364/2587-6821-2020-4-6-352-357.
The management of pregnant women with carbohydrate metabolism disorders is still challenging due to high disease control requirements. Even insignificant deviations fr om the target values during pregnancy have certain risks. On the one hand, diabetes is associated with various obstetric conditions and the abnormalities of fetal growth. On the other hand, pregnancy can make diabetes worse by increasing the risks of the development and progression of diabetes complications thus requiring careful monitoring throughout the pregnancy .
According to the International Diabetes Federation, more than 463 mln individuals aged 20-79 years (i.e., 9.3% of adults) currently suffer from diabetes. In addition, 1.1 mln children and adolescents younger than 20 years suffer from type 1 diabetes (T1D). An estimated prevalence of diagnosed diabetes is 578 mln in 2030 and 700 mln in 2045 . By January 2019, 4.58 mln patients with diabetes were registered in the Federal Registry of Type 1 Diabetes of the Russian Federation (3.12% of Russian population) . About 30-40% of diabetics including those with type 2 diabetes (T2D) are individuals of reproductive age. These findings demonstrate that more and more women of reproductive age suffer from carbohydrate metabolism disorders. As a result, special attention needs to be focused on the careful planning and management of pregnancy to reduce the risk of unfavorable outcomes for the mother and the child.
Pregnancy may be complicated by various carbohydrate metabolism disorders, i.e.:
· pre-gestational diabetes pre-existing before pregnancy (T1D, T2D etc.);
· manifest diabetes (T1D, T2D etc.) diagnosed during pregnancy;
· gestational diabetes (carbohydrate metabolism disorders developing during pregnancy and characterized by less severe hyperglycemia that is inconsistent with manifest diabetes criteria).
Hyperglycemia during pregnancy may result in various complications both in the mother and the child. The most important complications are spontaneous abortion, preeclampsia, premature birth, macrosomia (big baby), traumatic birth, neonatal hypoglycemia etc. The improvement in blood glucose control and diabetes compensation before and during the pregnancy are the most effective tools to minimize diabetes-associated risks . Meanwhile, managing glycaemia during pregnancy may be challenging both for doctors and women due to the specificities of carbohydrate metabolism, impaired sensitivity to insulin, and glycemic lability. Treatment efficacy directly correlates with an active competent self-monitoring implemented by a woman herself at home. Therefore, all women with diabetes and gestational diabetes require a training. They should be provided with basic skills, i.e., self-monitoring of blood glucose and ketonuria levels and keeping a diabetes diary, the adjustment of the dose of insulin based on blood glucose level and meal, the prevention and treatment of hypoglycemia and ketoacidosis, adherence to rational nutrition principles, and exercising.
Self-monitoring during pregnancy
The conventional methods of self-monitoring in diabetes include blood glucose testing using blood glucose meters and blood and/or urine testing for ketones.
Glycemic targets in pregnant women with manifest diabetes are as follows :
· fasting/pre-prandial/before night/at night blood glucose < 5.3 mmolе/l;
· blood glucose one hour after a meal < 7.8 mmolе/l or two hours at a meal < 6.7 mmolе/l;
· НbА1c < 6%.
Glycemic targets in gestational diabetes are as follows:
· fasting/pre-prandial/before night/at night blood glucose < 5.1 mmolе/l;
· blood glucose one hour after a meal < 7.0 mmolе/l.
During pregnancy, the rate of blood glucose testing is of crucial importance irrespective of diabetes type. In pregnancy, glycemic indices and sensitivity to insulin are changing, the doses of insulin often require adjustment. Considering this, women are recommended with keeping a detailed diary. The rate of blood glucose monitoring during pregnancy in women receiving insulin therapy should be at least 7 or 8 times daily. Additional control is often required when feeling unwell, having the risk of hypoglycemia, or titrating insulin dose. Moreover, glycated hemoglobin (HbA1c) test should be performed every 2 or 3 months during pregnancy. In healthy pregnancy, the lifespan of red blood cells reduces. As a result, the exposure of red blood cells to glycation decreases potentially leading to underestimated HbA1c levels . This emphasizes the importance of dynamic daily glycemic monitoring. However, frequent self-monitoring may impair daily life being associated with non-adherence to recommendations. In addition, indirect signs of hyperglycemia (e.g., diabetic fetopathy diagnosed by ultrasound) are common even in achieved glycemic targets as reported by diabetic diary. This can be accounted for by the episodes of occult hyperglycemia not detected during the measurements.
Relevance of glycemic variability
In the last years, the conception of carbohydrate metabolism control based on the assessment of glycemic variability (GV) gains an increasing attention when discussing diabetes complications. Numerous studies suggest that the chaotic measurements of blood glucose levels using glucose meters in the daytime as well as HbA1c measurements do not allow for assessing the amplitude of glycemic fluctuations throughout the day and do not illustrate some important parameters of glycemic profile, i.e., the time spent in hypo- or hyperglycemia and GV. In the same HbA1c level, the difference in the range of glycemic fluctuations in the day time is the key factor affecting the development of unfavorable outcomes. According to some investigators, significant GV is a more important risk factor for the development of diabetes complications than chronic hyperglycemia . In manifest diabetes, the contribution of GV to the development of complications is clear. However, the role of this factor in gestational diabetes remains unclear. The studies comparing GV in women with gestational diabetes and pregnant women without carbohydrate metabolism disorders produced controversial results. Some authors have demonstrated that blood glucose level fluctuations are more significant in pregnant women with gestational diabetes compared to healthy pregnant women [6-8]. Thus, R. Mazze et al. revealed significantly higher GV in pregnant women with gestational diabetes compared to pregnant women with normal blood glucose levels . Similar findings were reported by Su et al. and other investigators . Therefore, GV being a component of glycemic disorders has a more significant effect on the development of diabetes complications than chronic hyperglycemia .
A set of parameters and indices calculated on the basis of continuous glucose monitoring (CGM) data may be applied. CGM provides a better understanding of glycemic excursions including their duration and rate. The mean amplitude of glycemic excursions (MAGE) which is a mean amplitude of glucose fluctuations more than one standard deviation (SD) above the mean (modulo) is one of the key parameters to assess GV. MAGE is known to correlate with other GV parameters, in particular, with various options of SD calculation (i.e., diurnal, interdaily, prandial, nocturnal) that are now included in routine CGM protocols. To assess blood glucose variability, McDonnell et al. proposed a novel index, continuous overlapping net glycemic action (CONGA), that ensures more careful measurement of diurnal glucose variations . A high CONGA value indicates unstable blood glucose control while a low CONGA value reflects stable blood glucose control. Since most indices mainly depend on high blood glucose levels, low glycaemia commonly escapes our attention. In 2006, Kovatchev et al.  proposed an average daily risk range (ADRR) as a novel indicator to evaluate GV which is equally sensitive to hypo-and hyperglycemia and can be easily determined by self-checking. ADRR value is a glycaemia converted to a corresponded risk of hypo-and hyperglycemia. ADRR value is the basis for the division into categories by the risk of glycaemia lability, i.e., low (0-19), moderate (20-40), or high (more than 40). The American Diabetes Association (2020) proposes a novel criterion, time-in-range (TIR) which is the percentage of time that a person spends with his/her blood glucose levels in a target range over a 24-hour period. The aim of TIR is to provide a stable “glucose homeostasis”. TIR goal is more than 70%. TIR less than 70% indicates glucose fluctuations which require interventions .
Hence, modern CGM devices are very useful in pregnancy in terms of more detailed information on glycemic curve, in particular, in labile diabetes course or difficulties with assessing the compensation of gestational diabetes.
CGM during pregnancy
In addition to obvious increase in the rate of blood glucose testing, CGM provides more detailed information on the pattern and trends of its changing and glycemic fluctuations, identifies the episodes of occult nocturnal hypoglycemia and postprandial hyperglycemia. The analysis of CGM glucose readings helps better adjust insulin therapy or decide on its initiation, modify meal plan and physical activity.
The effects of CGM on the health of mothers and newborns were evaluated during the CONCEPTT study . Two groups were enrolled, i.e., pregnant women and women planning pregnancy. CONCEPTT included 215 pregnant women with type 1 diabetes who received insulin therapy. In 108 women, blood glucose levels were measured using CGM device and glucose meters (the latter was used for the calibration of CGM device). In 107 women, blood glucose levels were measured using glucose meter only (control group). It was demonstrated that pregnant women who use CGM device spend more time with their blood glucose levels in a target range compared to the control group (68% vs. 61%, respectively) and less time with hyperglycemia (27% vs. 32%, respectively). The rate and total duration of hypoglycemic episodes were similar. Target HbA1c level was achieved in 66% of CGM group women compared to 40% of control group women. It should be emphasized that the rate of the births of large for gestational age babies, the rate of intensive care interventions more than 24 hours, and the length of stay in maternity hospital have been reduced by half in CGM group. However, more adverse reactions (i.e., skin irritation presumably resulting from sticky sensor) were reported in CGM group (48%) compared to the control group (40%).
In 2008, the Hyperglycemia and Adverse Pregnancy Outcomes (HARO) study  that assessed the consequences of hyperglycemia in pregnant women with gestational diabetes revealed the association between elevated blood glucose levels and each of 5 secondary outcomes (premature birth, shoulder dystocia or birth injury, intensive neonatal care, elevated bilirubin, and preeclampsia). It was demonstrated that MAGE can be regarded as a prognostic marker of preeclampsia, macrosomia, neonatal hypoglycemia, and combined neonatal outcome. The 24-h mean blood glucose (MBG), another parameter of glycemic curve, is associated with neonatal complications, e.g., macrosomia, low birth weight, and newborn respiratory distress syndrome. It was also demonstrated that the use of CGM devices in addition to the conventional methods of controlling glycaemia can reduce the risk of unfavorable outcomes in gestational diabetes both for the mother and the child due to improved GV.
Murphy et al. have also established better glycemic control and pregnancy outcomes in T1D and T2D due to the use of CGM devices . The use of these devices was associated the reduced risk of preeclampsia, rate of C-section, and neonatal complications and less birth weight. However, some studies comparing the efficacy of CMG devices and glucose meters for the self-monitoring of glycaemia in gestational diabetes failed to demonstrate any significant differences. Primary outcomes, i.e., the rate of C-section, perinatal mortality, macrosomia, and neonatal hypoglycemia were similar in conventional self-monitoring group and CGM group. Significant difference was revealed in terms of gestational weight gain and more common insulin therapy prescription in favor of CMG group. Similar results failed to demonstrate significant positive effects of CGM on pregnancy outcomes were produced by GlucoMOMS study  which included 300 women with T1D and T2D (gestational age less than 16 weeks) or gestational diabetes (gestational age less than 30 weeks). This study compared pregnancy outcomes (in particular, the rate of macrosomia) in women who self-monitored blood glucose using glucose meter (5 to 7 times daily) and women in whom “blind” CGM with the subsequent adjustment of therapy was performed. The rate of macrosomia was 31.0% in CGM group and 28.4% in glucose meter group. HbA1c levels were equal as well. Hence, retrospective CGM analysis provided a detailed information on glycemic fluctuations but was not associated with the reduced risk of macrosomia.
Flash glucose monitoring during pregnancy
Currently, the possibilities of glucose monitoring have been expanded greatly. CGM can be blinded (professional), real-time (permanent), and by periodical scanning (flash monitoring). Flash monitoring devices display the level of glucose in the interstitial fluid and, similar to CGM devices, read the data over a 14-day period. In contrast to CGM devices, flash monitoring devices do not require calibration with a glucose meter due to a technology allowing for factory calibration without having to prick the fingers to measure blood glucose. Another feature that distinguishes flash glucose monitoring (FGM) is that glucose data are available only on demand being not displayed continuously. The trends (indicated using an arrow) and graphs for previous 8 hours can also be seen on the screen . Frequent measurements of glucose concentration allow for a reduced time in hypo- or hyperglycemia and an improvement in mean glucose level due to the adjustment of therapy.
Currently available data on the effect of flash monitoring on diabetes course and its complications during pregnancy are scarce. One study evaluates the eligibility and accuracy of the data obtained by FGM vs. glucose meters in pregnant women with diabetes. 74 pregnant women with T1D, T2D, or gestational diabetes who received insulin therapy, diet therapy, or metformin were enrolled in this prospective multicenter study. The sensors were inserted for 14 days. Glucose readings were compared to the values obtained by a glucose meter (the measurements were performed at least 4 times daily). It was demonstrated that the clinical accuracy of FGM device is 88.1% compared to glucose meters, overall mean relative difference was 11.8%. These findings were not affected by diabetes type, gestational age, maternal age, or body mass index. No unexpected adverse device effects were reported. Hence, this study demonstrated a good conformity of sensor’s readings with capillary blood glucose levels thereby confirming the eligibility of FGM for the management of pregnant women with carbohydrate metabolism disorders. The accuracy of FGM was not affected by patient characteristics thus indicating its safety in pregnant women with gestational diabetes. The convenience of its use in pregnancy is accounted for by the lack of the need to prick the fingers (including finger pricking for calibration as in CGM) thereby resulting in more frequent glucose self-monitoring and improved glycaemia . The other comparative study  has demonstrated that FGM is superior to the conventional self-monitoring using a glucose meter. FGM has a positive effect on the time in hypoglycemia (< 3.9 mmole/l) which reduced by 38% without changing the total daily insulin dose . Further studies are certainly required to assess the efficacy of FGM in terms of improving glycemic control and pregnancy outcomes both for the mother and the child.
Disadvantages of CGM during pregnancy
CGM is very useful as an additional tool of glycemic control during pregnancy. However, some factors may lim it the use of these devices [21-23]. Thus, there may be discomfort when wearing a sensor, and this discomfort becomes more significant as pregnancy term and belly sizes increase. Meanwhile, FGM devices having a sensor inserted on the back of the upper arm are lacking this disadvantage. The drawbacks of these devices are also the need to involve health care providers to analyze the data obtained, their limited understanding and the need for training. Additionally, technical challenges and the inaccuracy of data provided by CGM devices, and the need of calibration (not for all devices) may be considered the reasons to dismiss glucose meters although manufacturers improve the informativity and sensitivity of sensors every year. Moreover, pregnancy is accompanied by the physiological changes in the composition of interstitial fluid. This factor can also affect the accuracy of sensors. However, one study failed to confirm the impact of this factor . The high cost of these devices clearly limits the clinical use of CGM devices . In conclusion, the potentialities, safety, and accuracy of CGM devices improve and many disadvantages are minimized thus making these devices more routine, useful, and available.
Remote glucose monitoring during pregnancy
In recent years, remote glucose monitoring using special programs has gained popularity in clinical practice. This technique allows for the viewing of the data of glucose meter, CGM, or FGM as graphs and other reports using a special software (e.g., CareLink and CareLink Pro for Medtronic [26–29]; Studio, Share, and Clarity for Dexcom , Tidepool Blip , and Diasend ). Software and online programs can be used both for the real-time remote control and retrospective monitoring of glucose levels in patients with diabetes [33–35]. Some studies analyzed the feasibility and effectiveness of the remote monitoring of glucose meter data. These data were further applied to adjust the therapy for gestational diabetes and T1D in pregnant women [36–39]. The results of the analysis of the distant monitoring of CGM in pregnant women with T1D were discussed during the scientific session of the American Diabetes Association in 2016. These findings demonstrate the tendency to the improved control of blood glucose and the reduced risk of hypoglycemia .
The programs of remote glucose monitoring are currently missing in Russian Federation. The studies assessing the efficacy and utility of this technique of glycemic control are underway. Maybe in the near future doctor-patient relationship during treatment selection and adjustment (which is particularly important during pregnancy) will be further developed.
Currently, the efficacy and utility of modern glucose monitoring technologies for the prevention of various diabetes complications during pregnancy are controversial. Various studies to establish whether the broad application of modern CGM devices in routine clinical practice is required during pregnancy are underway. These studies involve both manifest carbohydrate metabolism diseases and gestational diabetes. As to manifest carbohydrate metabolism diseases, the advantages of CGM are clear. However, boundary alterations typical for gestational diabetes require further studies to evaluate the eligibility and validity of these methods of glycemic monitoring. The evidence of CGM potentialities can provide a basis for increasing the application of these devices in routine clinical practice thereby improving the management of pregnant women with carbohydrate metabolism disorders.
About the authors:
Fatima O. Ushanova — assistant of the Department of Endocrinology of the Medical Faculty, Pirogov Russian National Research Medical University, 1, Ostrovityanov str., Moscow, 117437, Russian Federation; ORCID iD 0000-0001-5512-6899.
Tat’yana Yu. Demidova — Doct. of Sci. (Med.), Professor, Head of the Department of Endocrinology of Medical Faculty, Pirogov Russian National Research Medical University, 1, Ostrovityanov str., Moscow, 117437, Russian Federation; ORCID iD 0000-0001-6385-540X.
Contact information: Fatima O. Ushanova, e-mail: email@example.com. Financial Disclosure: no authors have a financial or property interest in any material or method mentioned. There is no conflict of interests. Received 23.08.2020, revised 03.09.2020, accepted 16.09.2020.
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