A single-arm, open-label study provides insight into the effects of switching from multiple daily insulin injections to use of an advanced hybrid closed loop system on glycemic control in pediatric patients with type 1 diabetes.
New research from investigators at Sidra Medicine in Doha, Qatar provides insight into impact of transitioning from multiple daily insulin injections to an advanced hybrid closed loop system on glycemic control in children and adolescents with type 1 diabetes.
A single-arm, prospective study conducted at the diabetes clinics at Sidra Medicine, results of the study indicate patients had increased time in range after transitioning from multiple daily injections to use of an advanced hybrid closed loop system in pediatric patients with type 2 diabetes.
“In this prospective open label single-arm, single-center, clinical investigation, we demonstrated that children and adolescent with type 1 diabetes on multiple daily injections can improve their glycemic control in a safe manner using a 10-day initiation protocol,” wrote investigators. “Beneficial effects on glycemic outcomes included increased time in range, decreased HbA1c levels, reduced time above the range without compromising hypoglycemic events, and decreased mean glucose concentration.”
Since the advent of continuous glucose monitoring technology, evidence-based approaches to optimal initiation and management with this technology has become invaluable. The current study was led by Goran Petrovski, MD, MSc, PhD, endocrinologist and professor in the Department of Pediatric Medicine at Sidra Medicine, and a team of colleagues with the intent of assessing glycemic outcomes in pediatric patients with type 1 diabetes previously treated with multiple daily injection who are transition to an advanced hybrid closed loop system, the MiniMed780G insulin pump system.
A prospective, open-label, single-arm study, enrollment occurred from October 25, 2020, through February 5, 2021. All patients included in the study had type 1 diabetes with an HbA1c less than 12.5%, been using multiple daily injections for at least 1 year with or without rtCGM or isCGM, and no prior pump experience. Exclusion criteria for the study included a total daily insulin dose less than 8 units and any episode of diabetic ketoacidosis in the 6 months prior to enrollment.
Overall, 41 patients were invited to take part in the study. Of these, 35 were recruited to take part and 34 completed the study. This cohort had a mean age of 12.5±32.7 years, 47% were male, the mean BMI was 20.4±3.8 kg/m2, and the mean HbA1c was 8.6±1.7%.
Patients included in the study followed a 4-step protocol that included a system assessment, system training, a 3-day period of sensor-augmented pump therapy, and system use for 12 weeks, which was known as the study phase. The primary outcome of interest for the study was change in time spent in the target range of 70-180 mg/dL and HbA1c from baseline to the study phase
At the end of the study, results indicated time in rage increased from 42.1±18.7% at baseline to 78.8±6.1% in the study phase (P <.001). Additionally, mean HbA1c among participants decreased from 8.6±1.7% at baseline to 6.5±0.7% at the end of the study (P=.001), with no episodes of severe hypoglycemia or diabetic ketoacidosis reported during the study.
“A 10-day structured protocol on AHCL MiniMed 780G system provides a novel therapeutic approach to optimize glycemic control in people with T1D, previously treated with MDI without prior pump experience,” wrote investigators. “The overall positive feedback from participants reflected the acceptance of new diabetes technology during daily diabetes management and might provide clinically significant benefits to their overall diabetes care.”
This study, “Glycemic outcomes of Advanced Hybrid Closed Loop system in children and adolescents with Type 1 Diabetes, previously treated with Multiple Daily Injections (MiniMed 780G system in T1D individuals, previously treated with MDI),” was published in BMC Endocrine Disorders.