Pediatric T1D Targets Improve Following Pump Initiation Protocol

Optimized goals of increased time spent in the target in range (TIR) and glycated hemoglobin A_1c (HbA_1c) consistently below 7% were seen among 34 pediatric patients living with type 1 diabetes (T1D) who were introduced to insulin pump use via a hybrid closed-loop (HCL) system through a 10-day protocol, reports a study published in BioMed Central Endocrine Disorders.

The HCL system evaluated in this study was the MiniMed 780G, and it had previously only been evaluated among persons with prior insulin pump experience. Sequential initiation protocol for this study consisted of introduction to the advanced HCL system (AHCL), AHCL system training, sensor augmented pump initiation, and AHCL initiation and 12-week follow-up. TIR was 70 to 180 mg/dL, and HbA_1c improvement was gauged by change from baseline of multiple daily injections (MDI) plus pump use to 12-week measure following AHCL initiation.

“The new generation of HCL systems now have additional features of automated bolus insulin correction for high glucose levels. These systems have the potential to improve glycemic outcomes across a broad age range and in people with different types of diabetes,” the study authors wrote. “To the best of our knowledge, this is the first clinical experience on the [AHCL] MiniMed 780G system in people with T1D, previously treated with MDI, without prior pump experience.”

There was 100% participation for the entire study, and no episodes of diabetic ketoacidosis or hypoglycemia were reported. TIR close to doubled, increasing from a mean (SD) 42.1% (18.7%) at baseline to 78.8% (6.1%) during the study phase (P < .001).

Meanwhile, HbA_1c decreased close to 25%. At baseline, the mean measure was 8.6% (1.7%), and this dropped to 6.5% (0.7%) (48 [7.7] mmol/mol) by the end of the study period.

The present patient population (mean [SD] age, 12.5 [3.7] years; 53% female; diabetes duration, 4.3 [2.9] years) were aged 7 to 17 years and receiving care through diabetes clinics at Sidra Medicine in Doha, Qatar. They had no history of pump use and their treatment consisted of MDI of insulin. Fifty-three percent reported self-monitoring of their blood glucose at study start. Recruitment was on a first-come, first-served basis from October 25, 2020, through February 5, 2021.

The authors’ data analysis also produced the following results:

• 30% drop in sensor glucose: from 198 (38) to 138 (12) mg/dL (P = .001)
• 74% of the patients reached TIR of 70%
• 38.5 percentage point drop in time above range: from 55.7% at baseline to 17.2% during weeks 9 through 12 of follow-up
• 7% drop in basal insulin use by the end of the study
• 94.5% (7.2%) overall sensor use
• 11.5% drop in the insulin-to-carbohydrate ratio (ICR): from 14.8 (7.0) to 13.1 (7.3) g

Evaluation of treatment satisfaction via the Diabetes Treatment Satisfaction Questionnaire Parents and Teens revealed that average scores rose for both groups. Among the study participants, mean (SD) scores rose from 3.6 (0.6) at baseline to 4.6 (0.8) at the end of the study period (P = .001). Their parents’ scores, meanwhile, rose from 3.5 (0.6) to 4.8 (0.9) (P = .001).

The authors highlighted that their findings demonstrate beneficial effects on glycemic outcomes that include increased TIR, decreased mean glucose concentrations, and decreased HbA_1c. In addition, the high satisfaction scores are a likely indicator of patient motivation and satisfaction from using the AHCL system.

However, they also noted that because their protocol was designed for a HCL and AHCL systems, a different protocol may be necessary for closed-loop systems. Their ICR also depended on their algorithm specifics, so what they used may not be applicable to all HCL systems, they wrote.

“Larger and long-term studies are needed to validate our findings,” they concluded.

Reference

Petrovski G, Al Khalaf F, Campbell J, et al. 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). BMC Endocr Disord. Published online March 29, 2022. doi:10.1186/s12902-022-00996-7