In the JournalsPerspective

Meta-analysis: Artificial pancreas systems improve glucose control in type 1 diabetes

In adults and children with type 1 diabetes, use of a closed-loop artificial pancreas system increased time in the recommended blood glucose range by a mean of 12.6% compared with standard insulin pump therapy, according to a meta-analysis of randomized controlled trials.

“Our meta-analysis demonstrated the efficacy and safety of the artificial pancreas in a much larger number of participants than any previous study has evaluated,” Alanna Weisman, MD, of the Leadership Sinai Center for Diabetes at Mount Sinai Hospital in Toronto, told Endocrine Today. “The artificial pancreas improves blood glucose control (time in target) and reduces hypoglycemia, regardless of differences in participant characteristics, study design and technical factors which differ for each artificial pancreas system.”

Alanna Weisman
Alanna Weisman

Weisman and colleagues analyzed 24 randomized controlled trials comparing artificial pancreas systems (insulin only or insulin plus glucagon) with conventional pump therapy (continuous subcutaneous insulin infusion with masked continuous glucose monitoring or unmasked, sensor-augmented pump therapy) in 585 adults and children with type 1 diabetes (219 in adult studies; 265 in pediatric studies; 101 in combined studies). Primary outcome was the mean difference in percentage of time spent in the target blood glucose range, assessed by random-effects meta-analysis.

Five studies assessed dual-hormone (insulin and glucagon) systems, two studies assessed both dual-hormone and single-hormone (insulin only) systems, and 20 studies assessed single-hormone artificial pancreas systems.

Researchers found time spent in the target blood glucose range was 12.59% higher in participants assigned to an artificial pancreas system (95% CI, 9.02-16.16), from a weighted mean of 58.21% for conventional pump therapy. Researchers observed a greater improvement in time-in-range with dual-hormone artificial pancreas systems (mean, 19.52%; 95% CI, 15.12-23.91) compared with single-hormone systems (mean, 11.06%; 95% CI, 6.94-15.18), but noted that six of seven comparisons compared dual-hormone systems to continuous subcutaneous insulin infusion with masked CGM, whereas 21 of 22 single-hormone comparisons had sensor-augmented pump therapy as the comparator.

Time spent in hypoglycemia was also 2.45% lower for participants assigned to artificial pancreas systems, the researchers wrote, from a weighted mean difference of 4.88% for conventional pump therapy, equivalent to a relative risk reduction of 50%. Differences in reduction of hypoglycemia were higher in studies with remote monitoring compared with studies without remote monitoring (–3.92% vs. –0.63%), researchers noted.

“These findings give us an estimate of the impact of artificial pancreas,” Weisman said. “We expect in clinical practice that it will improve time-in-target [glucose range] by 3 hours per day and reduce hypoglycemia by 35 minutes per day, without increasing total daily insulin dose.”Weisman noted that more studies are needed to determine if the artificial pancreas improves HbA1c.

“In addition, studies without remote monitoring are required to be certain of the reduction in hypoglycemia,” Weisman said. “Finally, direct comparisons of single and dual-hormone are needed.” – by Regina Schaffer

Disclosure: The researchers report no relevant financial disclosures.

In adults and children with type 1 diabetes, use of a closed-loop artificial pancreas system increased time in the recommended blood glucose range by a mean of 12.6% compared with standard insulin pump therapy, according to a meta-analysis of randomized controlled trials.

“Our meta-analysis demonstrated the efficacy and safety of the artificial pancreas in a much larger number of participants than any previous study has evaluated,” Alanna Weisman, MD, of the Leadership Sinai Center for Diabetes at Mount Sinai Hospital in Toronto, told Endocrine Today. “The artificial pancreas improves blood glucose control (time in target) and reduces hypoglycemia, regardless of differences in participant characteristics, study design and technical factors which differ for each artificial pancreas system.”

Alanna Weisman
Alanna Weisman

Weisman and colleagues analyzed 24 randomized controlled trials comparing artificial pancreas systems (insulin only or insulin plus glucagon) with conventional pump therapy (continuous subcutaneous insulin infusion with masked continuous glucose monitoring or unmasked, sensor-augmented pump therapy) in 585 adults and children with type 1 diabetes (219 in adult studies; 265 in pediatric studies; 101 in combined studies). Primary outcome was the mean difference in percentage of time spent in the target blood glucose range, assessed by random-effects meta-analysis.

Five studies assessed dual-hormone (insulin and glucagon) systems, two studies assessed both dual-hormone and single-hormone (insulin only) systems, and 20 studies assessed single-hormone artificial pancreas systems.

Researchers found time spent in the target blood glucose range was 12.59% higher in participants assigned to an artificial pancreas system (95% CI, 9.02-16.16), from a weighted mean of 58.21% for conventional pump therapy. Researchers observed a greater improvement in time-in-range with dual-hormone artificial pancreas systems (mean, 19.52%; 95% CI, 15.12-23.91) compared with single-hormone systems (mean, 11.06%; 95% CI, 6.94-15.18), but noted that six of seven comparisons compared dual-hormone systems to continuous subcutaneous insulin infusion with masked CGM, whereas 21 of 22 single-hormone comparisons had sensor-augmented pump therapy as the comparator.

Time spent in hypoglycemia was also 2.45% lower for participants assigned to artificial pancreas systems, the researchers wrote, from a weighted mean difference of 4.88% for conventional pump therapy, equivalent to a relative risk reduction of 50%. Differences in reduction of hypoglycemia were higher in studies with remote monitoring compared with studies without remote monitoring (–3.92% vs. –0.63%), researchers noted.

“These findings give us an estimate of the impact of artificial pancreas,” Weisman said. “We expect in clinical practice that it will improve time-in-target [glucose range] by 3 hours per day and reduce hypoglycemia by 35 minutes per day, without increasing total daily insulin dose.”Weisman noted that more studies are needed to determine if the artificial pancreas improves HbA1c.

“In addition, studies without remote monitoring are required to be certain of the reduction in hypoglycemia,” Weisman said. “Finally, direct comparisons of single and dual-hormone are needed.” – by Regina Schaffer

Disclosure: The researchers report no relevant financial disclosures.

    Perspective

    PERSPECTIVE

    Betul Hatipoglu

    This systemic review and meta-analysis is the first to generate pooled data. Keeping in mind that randomized clinical trials are the gold standard, this study is still important as we are preparing to use the first closed-loop pump in our clinical practice this month. It is reassuring to see that pooled analysis in this research paper of 24 studies confirmed and reinforced the individual findings pointing toward better blood sugar control. Use of the artificial pancreas helped to keep blood sugar within target range an extra 3 hours per day (12.9% increase time spent in blood sugar range that is goal). In addition to this decrease of blood sugars, there was an improvement in the burden of disease self-management as well as reduction in hypoglycemia. As we are approaching an era of booming technology in the treatment of diabetes, it is important to understand if the new advances indeed help with control while helping with quality of life and improving safety and protection from hypoglycemia. In clinical practice, we appreciate and understand these points, but insurance companies really need to see more of the objective information to reimburse the expenses of these improvements. 


    Betul Hatipoglu, MD

    Endocrinology, Diabetes and Metabolism

    Cleveland Clinic

    Disclosure: Hatipoglu reports no relevant financial disclosures.