Abstract:BACKGROUNDIn patients with type 1 diabetes who are not pregnant, closed-loop (automated) insulin delivery can provide better glycemic control than sensor-augmented pump therapy, but data are lacking on the efficacy, safety, and feasibility of closed-loop therapy during pregnancy.
METHODSWe performed an open-label, randomized, crossover study comparing overnight closed-loop therapy with sensor-augmented pump therapy, followed by a continuation phase in which the closed-loop system was used day and night. Sixtee… Show more
“…After the initial eight week trial, 14 women continued to use the closed loop system for approximately 15 additional weeks, including time in labor and delivery. In these women, glucose concentrations were in the target range 68.7% of the time with a mean concentration of 126 mg/dL (7.0 mmol/L) 47. However, no clear benefit of closed loop therapy on adverse pregnancy outcomes was seen, as 13 of the 16 newborns in the study cohort had a birth weight greater than the 90th centile 47…”
Section: Insulinmentioning
confidence: 82%
“…Also, sensor augmented insulin pumps have been developed to integrate real time CGM and insulin pump technologies. A proof of principle crossover trial was performed in 16 pregnant women with type 1 diabetes 47. Women were randomly assigned for a four week period to using a CSII pump and a continuous glucose sensor with or without tablet computer software that automatically adjusted the pump basal insulin rate at night.…”
Section: Insulinmentioning
confidence: 99%
“…Women were randomly assigned for a four week period to using a CSII pump and a continuous glucose sensor with or without tablet computer software that automatically adjusted the pump basal insulin rate at night. After four weeks, they switched to the other treatment group 47. Closed loop therapy resulted in a higher percentage of time in the designated euglycemic range (63-140 mg/dL (3.5-7.8 mmol/L)) than control therapy (74.7% v 59.5%; 95% confidence interval for the difference 6.1 to 24.2; P=0.002), and the overnight mean glucose concentration was lower with closed loop therapy than control therapy (119 v 133 mg/dL (6.6 v 7.4 mmol/L); P=0.009) 47.…”
Section: Insulinmentioning
confidence: 99%
“…After four weeks, they switched to the other treatment group 47. Closed loop therapy resulted in a higher percentage of time in the designated euglycemic range (63-140 mg/dL (3.5-7.8 mmol/L)) than control therapy (74.7% v 59.5%; 95% confidence interval for the difference 6.1 to 24.2; P=0.002), and the overnight mean glucose concentration was lower with closed loop therapy than control therapy (119 v 133 mg/dL (6.6 v 7.4 mmol/L); P=0.009) 47. After the initial eight week trial, 14 women continued to use the closed loop system for approximately 15 additional weeks, including time in labor and delivery.…”
Diabetes is a common complication of pregnancy, and the prevalence of all types of the disease is increasing worldwide. Diabetes in pregnancy is associated with short term and long term adverse effects for mother and child. The goal of treatment of diabetes in pregnancy is to minimize maternal and fetal adverse events related to hyperglycemia. Treatment options vary by type of diabetes, from a focus on lifestyle modifications in gestational diabetes to continuous glucose monitoring and insulin pumps in pregestational diabetes. Nevertheless, given the commonality of hyperglycemia, considerable overlap exists in the treatment of different types of diabetes in pregnancy. Also, despite ongoing research on treatment of diabetes in pregnancy for decades, changes in the characteristics of the patient population have highlighted the limited effectiveness of different therapies. Specifically, despite the co-occurrence of obesity and diabetes, treatment recommendations including glycemic targets are not altered in such cases and a single optimal treatment strategy for each type of diabetes in pregnancy does not seem to exist. Rather, the approach to treating pregnant women with diabetes likely needs to be individualized to maximize the short term and long term health of mother and child. This article will review recent clinical studies to summarize established treatment strategies and introduce novel therapies for diabetes in pregnancy.
“…After the initial eight week trial, 14 women continued to use the closed loop system for approximately 15 additional weeks, including time in labor and delivery. In these women, glucose concentrations were in the target range 68.7% of the time with a mean concentration of 126 mg/dL (7.0 mmol/L) 47. However, no clear benefit of closed loop therapy on adverse pregnancy outcomes was seen, as 13 of the 16 newborns in the study cohort had a birth weight greater than the 90th centile 47…”
Section: Insulinmentioning
confidence: 82%
“…Also, sensor augmented insulin pumps have been developed to integrate real time CGM and insulin pump technologies. A proof of principle crossover trial was performed in 16 pregnant women with type 1 diabetes 47. Women were randomly assigned for a four week period to using a CSII pump and a continuous glucose sensor with or without tablet computer software that automatically adjusted the pump basal insulin rate at night.…”
Section: Insulinmentioning
confidence: 99%
“…Women were randomly assigned for a four week period to using a CSII pump and a continuous glucose sensor with or without tablet computer software that automatically adjusted the pump basal insulin rate at night. After four weeks, they switched to the other treatment group 47. Closed loop therapy resulted in a higher percentage of time in the designated euglycemic range (63-140 mg/dL (3.5-7.8 mmol/L)) than control therapy (74.7% v 59.5%; 95% confidence interval for the difference 6.1 to 24.2; P=0.002), and the overnight mean glucose concentration was lower with closed loop therapy than control therapy (119 v 133 mg/dL (6.6 v 7.4 mmol/L); P=0.009) 47.…”
Section: Insulinmentioning
confidence: 99%
“…After four weeks, they switched to the other treatment group 47. Closed loop therapy resulted in a higher percentage of time in the designated euglycemic range (63-140 mg/dL (3.5-7.8 mmol/L)) than control therapy (74.7% v 59.5%; 95% confidence interval for the difference 6.1 to 24.2; P=0.002), and the overnight mean glucose concentration was lower with closed loop therapy than control therapy (119 v 133 mg/dL (6.6 v 7.4 mmol/L); P=0.009) 47. After the initial eight week trial, 14 women continued to use the closed loop system for approximately 15 additional weeks, including time in labor and delivery.…”
Diabetes is a common complication of pregnancy, and the prevalence of all types of the disease is increasing worldwide. Diabetes in pregnancy is associated with short term and long term adverse effects for mother and child. The goal of treatment of diabetes in pregnancy is to minimize maternal and fetal adverse events related to hyperglycemia. Treatment options vary by type of diabetes, from a focus on lifestyle modifications in gestational diabetes to continuous glucose monitoring and insulin pumps in pregestational diabetes. Nevertheless, given the commonality of hyperglycemia, considerable overlap exists in the treatment of different types of diabetes in pregnancy. Also, despite ongoing research on treatment of diabetes in pregnancy for decades, changes in the characteristics of the patient population have highlighted the limited effectiveness of different therapies. Specifically, despite the co-occurrence of obesity and diabetes, treatment recommendations including glycemic targets are not altered in such cases and a single optimal treatment strategy for each type of diabetes in pregnancy does not seem to exist. Rather, the approach to treating pregnant women with diabetes likely needs to be individualized to maximize the short term and long term health of mother and child. This article will review recent clinical studies to summarize established treatment strategies and introduce novel therapies for diabetes in pregnancy.
“…Closed-loop use in children and adolescents has shown improvement in either time spent in the glucose target range [19] or reduction in hypoglycaemia risk [20]. In pregnant women with type 1 diabetes, improvements in time in the glucose target range and mean glucose was achieved by closed-loop without increasing hypoglycaemia risk compared to sensor-augmented pump therapy [21]. …”
Section: Clinical Evidence Behind the Artificial Pancreasmentioning
BackgroundRapid progress over the past decade has been made with the development of the ‘Artificial Pancreas’, also known as the closed-loop system, which emulates the feedback glucose-responsive functionality of the pancreatic beta cell. The recent FDA approval of the first hybrid closed-loop system makes the Artificial Pancreas a realistic therapeutic option for people with type 1 diabetes. In anticipation of its advent into clinical care, we provide a primer and appraisal of this novel therapeutic approach in type 1 diabetes for healthcare professionals and non-specialists in the field.DiscussionRandomised clinical studies in outpatient and home settings have shown improved glycaemic outcomes, reduced risk of hypoglycaemia and positive user attitudes. User input and interaction with existing closed-loop systems, however, are still required. Therefore, management of user expectations, as well as training and support by healthcare providers are key to ensure optimal uptake, satisfaction and acceptance of the technology. An overview of closed-loop technology and its clinical implications are discussed, complemented by our extensive hands-on experience with closed-loop system use during free daily living.ConclusionsThe introduction of the artificial pancreas into clinical practice represents a milestone towards the goal of improving the care of people with type 1 diabetes. There remains a need to understand the impact of user interaction with the technology, and its implication on current diabetes management and care.
Importance:
The presence of preexisting type 1 or type 2 diabetes in pregnancy increases the risk of adverse maternal and neonatal outcomes, such as preeclampsia, caesarian section, pre-term delivery, macrosomia and congenital defects. Approximately 0.9% of the 4,000,000 births in the United States are complicated by preexisting diabetes.
Observations:
Women with diabetes have increased risk for adverse maternal and neonatal outcomes and similar risks are present for either type 1 or type 2 diabetes. Both forms of diabetes require similar intensity of diabetes care. Preconception planning is very important to avoid unintended pregnancies, and to minimize risk of congenital defects. Hemoglobin A1c goal at conception is <6.5% and during pregnancy is <6.0%. It is also critical to screen for and optimize comorbid illnesses such as retinopathy and nephropathy. Medications known to be unsafe in pregnancy, such as angiotensin-converting enzyme inhibitors and statins, should be discontinued. Obese women should be screened for obstructive sleep apnea, which is often undiagnosed and can result in poor outcomes. Blood pressure goals must be considered carefully, as lower treatment thresholds may be required for women with nephropathy. During pregnancy, continuous glucose monitor use can improve glycemic control and neonatal outcomes for women with type 1 diabetes. Insulin is first-line therapy for all women with preexisting diabetes; injections and insulin pump therapy are both effective approaches. Rates of severe hypoglycemia are increased during pregnancy; therefore glucagon should be available and close contacts trained in its use. Low-dose aspirin is recommended soon after 12 weeks of gestation to minimize the risk of preeclampsia. The importance of discussing long-acting reversible contraception before and after pregnancy cannot be overstated, to allow for appropriate preconception planning.
Conclusions and Relevance:
Preexisting diabetes in pregnancy is complex and is associated with significant maternal and neonatal risk, but optimization of glycemic control, medication regimens and careful attention to comorbid conditions can help mitigate these risks, and ensure quality diabetes care before, during and after pregnancy.
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