Optimizing Insulin Pump Therapy: Advanced Bolus Options

Introduction: Bolus calculator is an advanced function of insulin pump (IP). The use of bolus calculator increases the accuracy of calculation of the proper meal or corrective dose of insulin in patients with type 1 diabetes (T1D). Aim of the Study: Compare the difference in the parameters of glycemic control (HbA1c, postprandial increase of blood glucose and number of hypoglycemic episodes per week) between the group of patients who use bolus calculator for <50% of the total daily boluses, and the group of patients who use bolus calculator for ≥50% of total daily boluses. Patients and Methods: This study included 36 patients aged over 18 years with T1D on IP therapy in the Republika of Srpska. All patients used IP for at least one year prior to participation in the study. Before the IP therapy was initiated, all the patients were trained for carbohydrate counting in course of flexible insulin therapy training (FIT). Professional software, CareLink Pro® Software (Medtronic Inc., Northridge, CA, USA) was used to download data from insulin pumps to a personal computer. The default frequency of bolus calculator use was ≥50% of total daily boluses. Results: No statistically significant difference was found in HbA1c (6.61 ± 1.10 vs. 0.84 ± 6:56, p = 0.896) or the number of hypoglycemic episodes (2.00 (1.00, 4.00) (1.0 - 6.0) vs 3.00 (2.00, 4:00) (1.0 - 5.0), p = 0.298) between the group of patients who used bolus calculator for <50% of the total daily boluses, and the group of patients who used bolus calculator for ≥50% of total daily boluses. Patients who used bolus calculator had significantly lower postprandial increase in blood glucose after breakfast. Conclusion: In order to maximize all the advantages of IP therapy, a regular reeducation of both patients and diabetologists about advanced IP functions is needed for improving the glycoregulation in T1DM.

The impressive progress achieved in recent years in diabetes technologies has made diabetes technological devices such as continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) a significant part of diabetes treatment. Many studies conducted in recent years emphasized the advantages of using these technologies. The concept of the “human factor” in diabetes technologies as discussed in this chapter has several different aspects. First, it can refer to the way patients are satisfied with the use of the device and whether it is perceived convenient or inconvenient. For example, is the device perceived as “user friendly” (easy to learn and to operate, comfortable, does not cause many hassles). Second, there is the issue of effectiveness of the technology as it relates to their day-to-day diabetes management. For example, there is an improvement in glycemic control when one diabetes treatment regimen is compared to another (i.e., CSII vs. multiple daily injections (MDI)). Those two fundamental aspects may have different meanings for different groups. For example, different age groups (toddlers, children, adolescents, young adults, adults, and older people) can see different advantages and disadvantages in technological devices. The feasibility and utility of technological devices also need to fit the environments in which they will be used, such as school, the work place, and/or home. Specific subgroups such as diabetic youth with eating disorders can have unique interactions with diabetes technologies. In addition, diabetes technologies can be used as a measurement device, providing more rich and accurate data about patients' self-care that can contribute to our understanding of concepts such as adherence and satisfaction, and they can provide measurement tools to assess how glycemic control can effect cognition and intelligence. The present chapter will review articles published in the last year that have studied some of these issues.

Type 1 Diabetes in Children and Adolescents.

Background and Aims Point-of-care testing (POCT) for HbA1c may result in improved diabetic control, better patient outcomes and enhanced clinical efficiency with fewer patient visits and subsequent reductions in costs. In 2008, the Danish regulators agreed to create a new fee for the remuneration of POCT of HbA1c in primary care. The aim of this study is to describe and analyze the variation in use of POCT of HbA1c among diabetes patients in Danish general practice and municipalities. Method We use register data from the year 2011 to define a population of 172,906 diabetes patients. The POCT fee is used to measure the amount of POCT of HbA1c among diabetes patients. Next we apply descriptive statistics to analyze variation in the prevalence of POCT versus laboratory testing at patient, clinic and municipality level. We include patient characteristics such as gender, age, socioeconomic markers, health care utilization, case mix markers and municipality classifications. Results Only the Capital Region of Denmark has allowed GPs to use this new incentive for POCT. There were significant variations in the use of POCT across Danish regions, municipalities, clinics and patients. The number of diabetes patients per 1000 patients was larger in POCT clinics than Non-POCT clinics. Conclusion It is relevant to reassess the system for POCT of HbA1c in general practice across the five Danish regions and remedy variation in use of POCT of HbA1c in the Capital Region to avoid variation that is based on local medical opinion and/or supply of resources rather than patients’ health care needs and preferences.

Closing the loop

Insulin Pumps

Tight glycaemic control during pregnancy and birth often proves difficult. Yet maternal hyperglycaemia can have devastating consequences for mother and child. So in May the Joint British Diabetes Societies published guidelines to support pregnant women with diabetes who are admitted to obstetric wards. Meanwhile, the recent CONCEPTT study suggests that continuous glucose monitoring should become part of standard care for pregnant women with type 1 diabetes. Mark Greener examines why the JBDS guidelines and CONCEPTT strengthen health care professionals' ability to reduce the morbidity and mortality associated with diabetes in pregnancy. Diabetes during pregnancy can have devastating consequences for mother and child. Poorly-controlled type 1 diabetes (T1D), for instance, increases the risk of pre-eclampsia, caesarean section, preterm delivery, mortality, congenital abnormalities, being born large for gestational age (macrosomia) and admission to neonatal intensive care.1 Indeed, about half of children born to mothers with T1D experience complications arising from the maternal hyperglycaemia.1 Yet tight glycaemic control before and during pregnancy often proves elusive. For instance, changes in insulin sensitivity combined with considerable variations in insulin absorption during late pregnancy add to the difficulties of adjusting the insulin dose.1 Indeed, only 16.2% and 38.3% of pregnant women with T1D and T2D respectively in the UK achieve target HbA1c levels (<48 mmol/mol; 6.5%). This analysis of 3044 pregnancies managed in 155 NHS maternity clinics also found that, at 24 weeks' gestation, just 40.0% and 76.0% of pregnant women with T1D and T2D respectively achieved this target,2 despite attending antenatal clinics every two weeks and frequent contacts with health care professionals (HCPs) between visits.1 Furthermore, in 2015, the stillbirth rate was 10.7 per 1000 among the offspring of women with T1D and 10.5 per 1000 in those born to people with T2D, a marked increase compared to the rate of 4.7 per 1000 in the general maternity population. The stillbirth rate was, however, almost 2.5-fold lower than in 2002/2003. The neonatal death rate was 8.1 per 1000 for T1D and 11.4 per 1000 in women with T2D. In this case, however, the rates had not changed significantly since 2002/2003. The prevalence of all major and minor congenital anomalies was 46.2 per 1000 for T1D and 34.6 per 1000 for T2D.2 According to Public Health England, the rate of congenital anomalies was 20.5 per 1000.3 Tighter glycaemic control could prevent many maternal and neonatal complications. So, in May the Joint British Diabetes Societies (JBDS) published guidelines ‘to support management of glycaemic control when pregnant women with diabetes are admitted to obstetric wards’.4 Rather than diabetes specialists, the JBDS aimed the guidelines at obstetric HCPs, including midwives, health care assistants, diabetes teams, junior doctors, anaesthetists, obstetricians and paediatricians. ‘Most medicine is now super-specialised,’ says Helen Murphy, Professor of Medicine (Diabetes and Antenatal Care) at Norwich Medical School and Professor of Women's Health at King's College London who was involved in the guideline's development. ‘The obstetric teams are trained to deliver babies. It's not really reasonable to expect them to be experts in diabetes management as well.’ ‘Neonatal hypoglycaemia continues to affect nearly 30% of babies born to mothers with diabetes,’ adds Umesh Dashora, Consultant in Endocrinology and Diabetes at East Sussex Healthcare NHS Trust and the guideline's lead author. ‘The evidence suggests that tightly controlling blood glucose in mothers during labour and birth to between 4 and 7mmol/L, in line with NICE guidance, can reduce the risk of hypoglycaemia. Achieving this, however, remains a challenge.’ The guidelines, for example, highlight the ‘considerable variation in the criteria used for diagnosing and managing diabetes in pregnancy and considerable variation in the protocols across NHS trusts where they exist’.4 ‘Diagnosis and management of diabetes in pregnancy has been variable internationally and nationally,’ Dr Dashora says. ‘One reason for this inconsistency is a lack of high-quality data and evidence. Hopefully by following a standardised approach, as outlined in the guidelines, we will not only improve care but also collect vital data to support evidence-based practice in future.’ For instance, the guidelines note that there is no consensus about whether intravenous or subcutaneous insulin is most appropriate before and during delivery, and no clearly defined threshold for neonatal hypoglycaemia. Some studies suggest ‘a slightly relaxed’ blood glucose target of 4.0–8.0 mmol/L, which would often avoid the need for variable rate intravenous insulin infusion (VRIII) and possibly reduce the risk of maternal hypoglycaemia. On the other hand, the relaxed targets may increase the risk of neonatal hypoglycaemia. There is also a lack of consensus about the optimal management of capillary blood glucose levels when steroids are administered to reduce the complications of preterm labour.4 Clearly, several areas are worthy of further investigation. ‘Often we cannot wait for the results of randomised controlled trials before implementing improvements,’ Professor Murphy adds. ‘The number of pregnant women with T1D is relatively small, which makes performing a trial challenging and time consuming. There is, however, considerable empirical evidence, expertise and experience in managing diabetes in pregnancy. There were disagreements, such as around the “relaxed” targets, as we developed the guidelines. But in the absence of really clear evidence upon which to base management, the guidelines represent the wider view of specialists managing diabetes in pregnancy and aim to help services meet the NICE targets in more women.’ The guidelines recognise that different types of diabetes (T1D, T2D or gestational) may require individualised approaches depending on each woman's risk factors, treatment history, the risks of hypoglycaemia and anaesthesia, and presence of complications, including macrosomia and polyhydramnios (excessive amniotic fluid). But the guidelines summarise some basic principles, such as advocating hourly blood glucose monitoring during established labour and when pregnant women receive steroids. The guidelines suggest that VRIII is the most effective way to control steroid-induced hyperglycaemia, but note that women may continue insulin pump therapy and revert to VRIII if necessary.4 The guidelines also stress the importance of, for example, maintaining capillary glucose levels within the NICE range (4–7 mmol/L) during labour. The level of glucose control achieved is, however, more important than the method of insulin delivery (VRIII or insulin pump therapy). Women with T1D who are unable to maintain capillary glucose levels within the NICE range (4–7 mmol/L) and some women with T2D or gestational diabetes will require VRIII during labour. The infusion rate may need to be halved or changed to the lowest scale after placental delivery. The diabetes team should then review insulin requirements: the dose may be 25% less than that at the end of the first trimester. The guidelines also suggest providing written postnatal plans for women using insulin pumps.4 The need for more intensive management doesn't end when the woman leaves the delivery room. The JBDS guidelines note that breastfeeding mothers are at increased risk of hypoglycaemia and should have additional carbohydrate with meals or as a snack. Breastfeeding women with T2D can take metformin and glibenclamide, but should avoid other oral antidiabetic treatments and should not take drugs that were stopped after conception.4 In some cases, however, the obstetric team needs to take a back seat. ‘Pregnant women with diabetes may encounter many HCPs who have little knowledge of diabetes,’ Professor Murphy adds. ‘The women, in contrast, are often experts in self-managing diabetes. They can feel highly vulnerable leaving their glucose control “in the hands” of less experienced staff. If a woman is best placed to control the diabetes, the team needs to facilitate self-management.’ The JBDS guidelines suggest standardised protocols and charts, which can help achieve NICE targets during delivery and steroid administration for prematurity. ‘We hope that auditing the outcomes will gather much-needed evidence in this area and improved care will follow,’ Dr Dashora notes. ‘Audit could, for example, identify the ideal capillary blood glucose during delivery, birth and steroid administration that avoids neonatal hypoglycaemia and any other complications, and whether any associated increase in maternal hypoglycaemia is clinically significant.’ In the meantime, continuous glucose monitoring (CGM) should become part of the standard care package for pregnant women with T1D, Professor Murphy believes. ‘Unfortunately, there is no compelling evidence supporting CGM use during labour and delivery,’ she says. ‘Obstetric teams should, however, be aware that increasing numbers of women will be using CGM to support optimal self-management.’ Professor Murphy was the senior author of the recently published open-label CONCEPTT trial, which randomised 215 pregnant women and 110 planning pregnancy to CGM or standard measurements. CGM did not seem to routinely benefit all women planning to become pregnant. However, in pregnant women mean HbA1c was 0.2% lower in the CGM arm. Furthermore, pregnant women using CGM spent an additional 1.7 hours or 68% of the time within the glucose target range (3.5–7.8 mmol/L) compared to 61% of the time in controls. Pregnant women using CGM also spent approximately 1 hour less time hyperglycaemic (27% and 32% respectively). Both these differences were statistically significant. No significant difference emerged in severe hypoglycaemia episodes (18 and 21 respectively) and time spent hypoglycaemic (3% and 4% respectively), although rates were low in both the CGM and control groups.1 CGM was also associated with improved neonatal outcomes. For instance, the odds ratio of having an infant born large for gestational age declined by 49% in the CGM group compared to controls. The odds ratio of neonatal intensive care admissions lasting more than 24 hours declined by 52% and of neonatal hypoglycaemia by 55% in the CGM group.1 ‘In my view, the evidence is strong enough to offer CGM routinely to pregnant women using intensive insulin therapy,’ Professor Murphy says. ‘Moreover, the results were consistent across the 31 centres in six countries in CONCEPTT and consistent among insulin pump and insulin injection users. So the results seem to be reliable and robust. The numbers needed to treat to avoid a neonatal complication are between 6 and 8, which is much lower than for many other established interventions. There's no doubt that CGM use during pregnancy is a clinically effective intervention.’ Hospital stay was shorter by one day in the CGM group.1 Professor Murphy speculates that the shorter hospital stay and the fewer neonatal intensive care admissions might offset the costs of CGM. ‘We need a health economic analysis,’ she says. ‘But I expect that CGM will prove cost effective and it is certainly better for the patient.’ The guidelines and CONCEPTT strengthen HCPs' ability to prevent much of the morbidity and mortality associated with diabetes in pregnancy. As Professor Murphy concludes: ‘Services need to develop the best way to implement CGM and the new guidelines locally to optimise glucose control and improve outcomes for mothers and their babies.’ References are available online at www.practicaldiabetes.com.

Real-World Diabetes Technology: Overcoming Barriers and Disparities.

The Official Journal of ATTD Advanced Technologies &amp; Treatments for Diabetes Conference <i>Berlin, Germany—February 20–23, 2019</i>

Persistence with insulin pump therapy among children and young adults with type 1 diabetes in Germany: An update.

Abstracts from ATTD 20158th International Conference on Advanced Technologies &amp; Treatments for DiabetesParis, France—February 18–21, 2015

In-hospital Management of Diabetes

Medical prosthetics, such as insulin pumps, are used to augment the management of chronic illnesses, such as Type 1 diabetes (T1D). I was diagnosed at the age of eight with this illness, but the few years before my diagnosis, I was like a huge sponge that was continually squeezed. My bladder was out of control. I peed while marching in a parade at my kindergarten. I let loose on a stranger’s welcome mat because I couldn’t make it to my toilet. Everyone thought it was just a phase, something I would “grow out of”. After about two years, I hadn’t.The easiest thing to blame was my excessive intake of water. I would drink an inordinate amount of water at all hours of the day. In the middle of the night, I would wake up and get myself a glass. Or two. Or three. During these times, my friends were in awe that I could walk alone, without fear, in the dark. For a seven-year-old that was tantamount to being a hero. But the only thing on my mind was the refreshing gush of water.I was a bottomless pit. Any amount of liquid and food that I swallowed seemed to disappear. I rapidly lost weight despite my enormous appetite. A few months after my eighth birthday, my Uncle John, a student doctor at the time, suspected I had diabetes. Although I didn’t know what diabetes was, it seemed like it would change my life forever. I wasn’t ready for change. But with great anxiety, I did the urine test. And it changed my life by saving it. If I hadn’t been diagnosed as having Type One diabetes, I would have died. With this auto-immune illness, the pancreatic cells which secrete a hormone called insulin (used to regulate blood glucose levels) are incapacitated. Consequently, for those who have T1D, external administration of insulin is needed.Fig. 1. Injection.Unlike those with Type 2 diabetes, those with T1D always need insulin injections, regardless of how well they maintain their exercise and dietary regimes. For many, insulin injections are needed. For others, an insulin pump is used to administer insulin in a manner that seeks to mimic a functional, biological pancreas. In this context, an insulin pump is an option used to keep those with T1D alive and can improve how diabetes care proceeds. For instance, in my 28 years of having T1D, I have injected myself with insulin daily to stay alive. In the early years of having the illness, I needed two injections a day. This increased to five insulin injections for two years. The toll this took on my body could be evidenced in scars, bruises and fatty lump deposits from where a syringe had punctured my flesh. However, after transitioning to insulin pump therapy, I only needed to inject myself once every three days, allowing my flesh more time to heal. In this case, insulin pump therapy helped the appearance and health of my skin, while also enabling me to feel more empowered in the face of an incurable illness. This article explores insulin pump usage as a means to manage T1D. In regards to this, the article also asks broader questions: What happens when insulin pump technologies fail? What then happens to the human body that is attached to the pump? How can we speak, write and think about re-organised bodies in which, for example, an internal organ’s pancreatic beta cells (those that secrete insulin), are external to the body and battery operated? Re-Organising the “Whole” BodyAnnemarie Mol and John Law specify, “In western theoretical tradition ‘the body’ is characteristically evoked as the exemplary case of what it is to be whole” (57). Yet, despite this characterisation of a coherent body, the body itself is a “set of tensions” (54). In the context of diabetes, Mol and Law write, “there are tensions between the interests of its various organs. Regulating blood sugar tightly may be good for the arteries, the eyes and the neurons, but since it increases the risk of hypoglycaemia [low blood glucose levels], it is bad for the brain” (54). While one area of the body can benefit, another can simultaneously be compromised. In this context, the body is a site of contradiction and tension that “hangs together” through its incoherence and inconsistency. In the case of T1D, while the pancreatic cells which secrete insulin are destroyed, other cells within the body (and within the pancreas itself) continue to function “normally”. However, this continued “normality” brings heath complications. For instance, the pancreas also releases glucagon, which is the sugar found in the body. As a result of the lack of insulin in T1D, glucagon becomes unmanageable and causes blood glucose levels within the body to rise. The “normal” secretion of glucagon, in this case, produces complications to do with high blood sugar (for example, neuron damage and retinopathy). In this case, insulin pump therapy can be used to compensate for the “normal” and “abnormal” functions of the pancreas. The insulin pump thus attempts to bring the body, as much as possible, to a cohesive whole. However, this cohesiveness is arranged in a manner that pushes those with diabetes to rethink how the body is organised. According to the Juvenile Diabetes Research Foundation (JDRF), an insulin pump is “a small computerised device that delivers a slow continuous level of rapid acting insulin throughout the day. It can be programmed to give more or less insulin when and if required. The insulin is delivered through a tiny tube (cannula) under the skin that is changed every three days”. It is in Section C in the Australian Government Prostheses list.Fig. 2. Insulin pump.The insulin pump is thus a medical prosthetic designed to communicate with the functioning cells within the pancreas, and the rest of the body, in order to keep the body alive. Usually, only one AA or AAA battery is needed to power most insulin pumps. Life hangs on the life span of that battery, and if the pump is on low battery, then one’s body is also in danger of shutting down.The pump is also located on the outside of the body, with a small cannula being the only thing inserted beneath the skin. On the front of the pump is a visual display designed similarly to the appearance of a mobile phone. The display has a “home page” which shows the time, how much insulin is in the pump, as well as the status of the battery (low battery or not). By clicking onto one of the buttons on the pump, the display shows a menu divided into different sections, such as “bolus” (insulin needed when eating or correcting high blood glucose levels), “suspend” (to stop the pump from administering insulin), “basal” (which regulates the continuous amount of insulin administered 24/7), etc. By scrolling onto a specific category, the pump user can access other sub-categories which enable the user to program the pump. The pump makes visible something that is not usually visible, that is, how much insulin is administered into the body. The use of an insulin pump thus reorganises what can and cannot be seen, smelt, touched and heard. With the pump, users connect to insulin in a number of ways that those without diabetes do not. My experiences with the pump enable me to smell the synthetic insulin that courses through my pump’s tubing when it leaks and when I inject myself. With the pump, insulin becomes connected to certain sounds. The pump alarms when the insulin in its reservoir has been depleted. It beeps to signal certain basal rates. Sometimes it beeps for no identifiable reason. Additionally, I relate to the feel of insulin: the puncture of the syringe, the smoothness of the cannula, the tug of the tubing, the weight of the pump itself. Pump users also develop a tactile relationship with insulin through pressing the pump buttons to program how their pump delivers their insulin. This tactility becomes a daily sensation as the pump is attached to its user for most of their sleeping and waking hours. The pump is their bedtime companion, it is there during exercise, and it is there during rest. It becomes a daily reminder of the need to augment oneself in terms of one’s T1D. This is a daily reminder that is disseminated through the information the user programs into the pump and what the pump also displays for its user. For instance, before eating a meal, the pump user can input their blood glucose level (through first pricking their fingertip to extract blood and place this blood onto a test-strip which is inserted into a blood glucose machine), and how many grams of carbohydrates they are going to consume.Fig. 3. Checking blood glucose.A separate device, called a Continuous Glucose Monitor, can also be used in conjunction with the insulin pump to track blood glucose trends. The pump then calculates how much insulin is needed by assessing the user’s blood glucose level and the amount of carbohydrates they will eat/drink. This information is based on prior data the user and/or the user’s doctor has programmed into the pump to determine how sensitive the user is to insulin. In this context, the pump’s information can be accessed and programmed by its user, but this same data can also be seen and programmed by others (e.g. doctors, nurses, anyone who has access to the pump). This intercorporeality can be dangerous as the pump can be manipulated by people who are not even attached to it. Hacking the Insulin Pump and Other Technological limitsBarnaby Jack, a security researcher, “devised an attack that hijacks nearby insulin pumps, enabling him to surreptitiously deliver fatal doses to diabetic patients who rely on them” (Goodin). In this attack, Jack did not have to physically touch the pump or the person attached to it. Instead, Jack designed software and special antenna to communicate with the radio transmitters contained in some insulin pumps. Administering insulin, in this case, is about the communication between technologies, but in such a way that positions the person attached to the pump as a technology themselves. They are packaged in such a way that their body is the site through which ra

Self-monitoring of blood glucose is essential to optimise glycaemic control in type 1 diabetes mellitus. Continuous glucose monitoring (CGM) systems measure interstitial fluid glucose levels to provide semi-continuous information about glucose levels, which identifies fluctuations that would not have been identified with conventional self-monitoring. Two types of CGM systems can be defined: retrospective systems and real-time systems. Real-time systems continuously provide the actual glucose concentration on a display. Currently, the use of CGM is not common practice and its reimbursement status is a point of debate in many countries. To assess the effects of CGM systems compared to conventional self-monitoring of blood glucose (SMBG) in patients with diabetes mellitus type 1. We searched The Cochrane Library, MEDLINE, EMBASE and CINAHL for the identification of studies. Last search date was June 8, 2011. Randomised controlled trials (RCTs) comparing retrospective or real-time CGM with conventional self-monitoring of blood glucose levels or with another type of CGM system in patients with type 1 diabetes mellitus. Primary outcomes were glycaemic control, e.g. level of glycosylated haemoglobin A1c (HbA1c) and health-related quality of life. Secondary outcomes were adverse events and complications, CGM derived glycaemic control, death and costs. Two authors independently selected the studies, assessed the risk of bias and performed data-extraction. Although there was clinical and methodological heterogeneity between studies an exploratory meta-analysis was performed on those outcomes the authors felt could be pooled without losing clinical merit. The search identified 1366 references. Twenty-two RCTs meeting the inclusion criteria of this review were identified. The results of the meta-analyses (across all age groups) indicate benefit of CGM for patients starting on CGM sensor augmented insulin pump therapy compared to patients using multiple daily injections of insulin (MDI) and standard monitoring blood glucose (SMBG). After six months there was a significant larger decline in HbA1c level for real-time CGM users starting insulin pump therapy compared to patients using MDI and SMBG (mean difference (MD) in change in HbA1c level -0.7%, 95% confidence interval (CI) -0.8% to -0.5%, 2 RCTs, 562 patients, I(2)=84%). The risk of hypoglycaemia was increased for CGM users, but CIs were wide and included unity (4/43 versus 1/35; RR 3.26, 95% CI 0.38 to 27.82 and 21/247 versus 17/248; RR 1.24, 95% CI 0.67 to 2.29). One study reported the occurrence of ketoacidosis from baseline to six months; there was however only one event. Both RCTs were in patients with poorly controlled diabetes.For patients starting with CGM only, the average decline in HbA1c level six months after baseline was also statistically significantly larger for CGM users compared to SMBG users, but much smaller than for patients starting using an insulin pump and CGM at the same time (MD change in HbA1c level -0.2%, 95% CI -0.4% to -0.1%, 6 RCTs, 963 patients, I(2)=55%). On average, there was no significant difference in risk of severe hypoglycaemia or ketoacidosis between CGM and SMBG users. The confidence interval however, was wide and included a decreased as well as an increased risk for CGM users compared to the control group (severe hypoglycaemia: 36/411 versus 33/407; RR 1.02, 95% CI 0.65 to 1.62, 4 RCTs, I(2)=0% and ketoacidosis: 8/411 versus 8/407; RR 0.94, 95% CI 0.36 to 2.40, 4 RCTs, I(2)=0%).Health-related quality of life was reported in five of the 22 studies. In none of these studies a significant difference between CGM and SMBG was found. Diabetes complications, death and costs were not measured.There were no studies in pregnant women with diabetes type 1 and in patients with hypoglycaemia unawareness. There is limited evidence for the effectiveness of real-time continuous glucose monitoring (CGM) use in children, adults and patients with poorly controlled diabetes. The largest improvements in glycaemic control were seen for sensor-augmented insulin pump therapy in patients with poorly controlled diabetes who had not used an insulin pump before. The risk of severe hypoglycaemia or ketoacidosis was not significantly increased for CGM users, but as these events occurred infrequent these results have to be interpreted cautiously.There are indications that higher compliance of wearing the CGM device improves glycosylated haemoglobin A1c level (HbA1c) to a larger extent.

AimsThe effects of continuous subcutaneous insulin infusion (CSII) therapy with or without continuous glucose monitoring (CGM) on neonatal outcomes and glycemic outcomes of pregnant women with type 1 diabetes (T1D), living in Poland, were assessed.MethodsThis prospective observational study enrolled women with T1D (N = 481, aged 18–45 years) who were pregnant or planned pregnancy. All used CSII therapy and a subset used CGM with CSII (CSII + CGM). Neonatal outcomes (e.g., rate of large for gestational age [LGA] delivery [birth weight > 90th percentile]) and maternal glycemia (e.g., HbA1c and percentage of time at sensor glucose ranges) were evaluated.ResultsOverall HbA1c at trimesters 1, 2, and 3 was 6.8 ± 1.1% (50.9 ± 12.3 mmol/mol, N = 354), 5.8 ± 0.7% (40.1 ± 8.0 mmol/mol, N = 318), and 5.9 ± 0.7% (41.4 ± 8.0 mmol/mol, N = 255), respectively. A HbA1c target of < 6.0% (42 mmol/mol) at each trimester was achieved by 20.9% (74/354), 65.1% (207/318), and 58.0% (148/255), respectively. For women using CSII + CGM versus CSII only, HbA1c levels at trimesters 1, 2, and 3 were 6.5 ± 0.9% versus 7.1 ± 1.3% (47.8 ± 9.7 mmol/mol versus 54.3 ± 14.0 mmol/mol, p < 0.0001), 5.7 ± 0.6% versus 6.0 ± 0.9% (38.9 ± 6.5 mmol/mol versus 41.6 ± 9.3 mmol/mol, p = 0.0122), and 5.8 ± 0.6% versus 6.1 ± 0.8% (40.3 ± 6.9 mmol/mol versus 42.9 ± 9.1 mmol/mol, p = 0.0117), respectively. For the overall, CSII only, and CSII + CGM groups, rates of LGA delivery were 22.7% (74/326), 24.6% (34/138), and 21.3% (40/188), respectively.ConclusionsObservational assessment of women with T1D using CSII therapy demonstrated low HbA1c throughout pregnancy and low rates of LGA. The addition of CGM to CSII therapy compared to CSII therapy alone was associated with some improved maternal glycemic and neonatal outcomes.Clinicaltrials.gov identifierNCT01779141 (January 2013).