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237
result(s) for
"Insulin Infusion Systems - adverse effects"
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Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes
2022
In a 13-week, randomized trial involving persons 6 to 79 years of age with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction in the glycated hemoglobin level than standard care.
Journal Article
Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes
2019
Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes. In this 6-month randomized, multicenter trial involving such patients, a closed-loop system led to a greater percentage of time with the glucose level in a target range than did a sensor-augmented insulin pump.
Journal Article
A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes
by
Kollman, Craig C
,
Schoelwer, Melissa
,
Dokken, Betsy B
in
Adolescent
,
Automation
,
Blood Glucose
2020
A closed-loop system (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes. In this 16-week trial, the glucose level was in the target range for a greater percentage of time with a closed-loop system than with a sensor-augmented insulin pump.
Journal Article
Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes
by
Hovorka, Roman
,
Flanagan, Emma
,
Hammond, Matthew
in
Adult
,
Automation
,
Blood Glucose - analysis
2023
This trial randomly assigned pregnant women with type 1 diabetes to standard insulin therapy with continuous glucose monitoring or to hybrid closed-loop therapy. The latter significantly improved maternal glycemic control.
Journal Article
Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes
by
DeBoer, Mark D.
,
Schoelwer, Melissa
,
Breton, Marc D.
in
Adolescent Medicine
,
Age groups
,
Algorithms
2023
Closed-loop control systems of insulin delivery may improve glycemic outcomes in young children with type 1 diabetes. The efficacy and safety of initiating a closed-loop system virtually are unclear.
In this 13-week, multicenter trial, we randomly assigned, in a 2:1 ratio, children who were at least 2 years of age but younger than 6 years of age who had type 1 diabetes to receive treatment with a closed-loop system of insulin delivery or standard care that included either an insulin pump or multiple daily injections of insulin plus a continuous glucose monitor. The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring. Secondary outcomes included the percentage of time that the glucose level was above 250 mg per deciliter or below 70 mg per deciliter, the mean glucose level, the glycated hemoglobin level, and safety outcomes.
A total of 102 children underwent randomization (68 to the closed-loop group and 34 to the standard-care group); the glycated hemoglobin levels at baseline ranged from 5.2 to 11.5%. Initiation of the closed-loop system was virtual in 55 patients (81%). The mean (±SD) percentage of time that the glucose level was within the target range increased from 56.7±18.0% at baseline to 69.3±11.1% during the 13-week follow-up period in the closed-loop group and from 54.9±14.7% to 55.9±12.6% in the standard-care group (mean adjusted difference, 12.4 percentage points [equivalent to approximately 3 hours per day]; 95% confidence interval, 9.5 to 15.3; P<0.001). We observed similar treatment effects (favoring the closed-loop system) on the percentage of time that the glucose level was above 250 mg per deciliter, on the mean glucose level, and on the glycated hemoglobin level, with no significant between-group difference in the percentage of time that the glucose level was below 70 mg per deciliter. There were two cases of severe hypoglycemia in the closed-loop group and one case in the standard-care group. One case of diabetic ketoacidosis occurred in the closed-loop group.
In this trial involving young children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with a closed-loop system than with standard care. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; PEDAP ClinicalTrials.gov number, NCT04796779.).
Journal Article
Home Use of an Artificial Beta Cell in Type 1 Diabetes
2015
In two randomized trials conducted under home conditions, investigators compared closed-loop insulin delivery with sensor-augmented pump therapy in adults and in children and adolescents for 12 weeks. The closed-loop approach improved glucose control and reduced hypoglycemia.
Intensive insulin therapy is the standard of care for type 1 diabetes but is limited by the risk of hypoglycemia,
1
which leads to failure in achieving treatment goals for most patients in all age groups.
2
,
3
Among patients with type 1 diabetes, hypoglycemia is common, has a major effect on patients’ quality of life and psychological well-being,
4
and may cause seizures, which is of particular concern during the overnight hours in children and adolescents.
5
New approaches (e.g., continuous glucose monitoring) can improve glycemic control when the patient wears the sensors on a regular basis.
6
,
7
If insulin delivery is linked . . .
Journal Article
A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes
by
Blevins, Thomas
,
Sasson-Katchalski, Ravid
,
Atakov Castillo, Astrid
in
Adult
,
Aged
,
Aged, 80 and over
2025
In this randomized, controlled trial involving adults with insulin-treated type 2 diabetes, automated insulin delivery resulted in lower glycated hemoglobin levels than continuous glucose monitoring alone.
Journal Article
Threshold-Based Insulin-Pump Interruption for Reduction of Hypoglycemia
2013
In this study involving patients with type 1 diabetes, sensor-augmented insulin-pump therapy plus automated insulin suspension when glucose dropped below 70 mg per deciliter reduced nocturnal hypoglycemia, without affecting glycated hemoglobin values.
Severe nocturnal hypoglycemia can be catastrophic,
1
,
2
and hypoglycemia remains one of the most formidable barriers to improving glycemic control in patients with diabetes.
3
Sensor-augmented insulin-pump therapy offers substantial glycemic benefits, as compared with multiple daily insulin injections, but has not been shown to lower the risk of severe hypoglycemia significantly.
4
The automatic suspension of insulin delivery when a preset sensor glucose threshold is reached has the potential to mitigate hypoglycemia. The low-glucose suspend feature, available in the Medtronic Paradigm Veo pump outside the United States since 2009, was used in this study in the intervention group; the feature allows . . .
Journal Article
Closed-Loop Insulin Delivery for Glycemic Control in Noncritical Care
2018
In this trial involving hospitalized patients with type 2 diabetes, closed-loop insulin delivery (artificial pancreas) resulted in better glucose control than standard subcutaneous insulin therapy without an increased incidence of hypoglycemia.
Journal Article
Nocturnal Glucose Control with an Artificial Pancreas at a Diabetes Camp
by
Kordonouri, Olga
,
Nimri, Revital
,
Danne, Thomas
in
Adolescent
,
Automation
,
Biological and medical sciences
2013
This randomized, crossover trial compared an artificial-pancreas system with a sensor-augmented pump for nocturnal glucose control in young persons with type 1 diabetes at a diabetes camp. The artificial pancreas resulted in less hypoglycemia and tighter glucose control.
Intensive insulin therapy is considered to be the standard treatment for tight blood glucose control in patients with type 1 diabetes, since it prevents long-term complications. Several studies have promoted the use of insulin pumps, glucose sensors, or a combination of the two devices (sensor-augmented pump)
1
–
3
to improve glucose control. However, the risk of hypoglycemia is still present with the use of all currently available therapies.
4
–
6
Maintenance of nocturnal euglycemia is extremely important and is challenging, since most cases of severe hypoglycemia occur at night.
7
,
8
Such episodes account for 75% of total hypoglycemic seizures in children
9
and . . .
Journal Article