10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes

Abstract

Aim The aim of this study was to evaluate the 10-day initiation protocol for MiniMed 670G hybrid closed-loop (HCL) system in individuals with type 1 diabetes on multiple daily injection (MDI) in achieving desirable glycemic control. Methods An open-label single-arm, single-center, clinical investigation in children aged 7-18 years on MDI following a structured protocol: 2 days, HCL system assessment; 5 days, HCL system training (2-h sessions on 5 consecutive days with groups of 3-5 participants and families); 3 days, Manual Mode use of HCL system; 84 days, Auto Mode use of the HCL system, cumulating in 10 days from MDI to Auto Mode activation. Results A total of 30 children (age 10.24 ± 2.6 years) were enrolled in the study, and all completed the planned 84 days on Auto Mode. The participants used the sensor for a median of 92% of the time and spent a median of 89% in Auto Mode. The mean HbA1c decreased from 8.2 ± 1.4% (66 ± 15.3 mmol/mol) at baseline to 6.7 ± 0.5% (50 ± 5.5 mmol/mol) at the end of the study (p = 0.017). Time in range (70-180 mg/dL) increased from 46.9 ± 18.5% at baseline to 75.6 ± 6.9% in Auto Mode (p < 0.001). This was achieved while spending 2.8% of the time below 70 mg/dL and without any severe hypoglycemia or DKA. Conclusion Children and adolescents with type 1 diabetes on MDI therapy can successfully initiate the HCL system, using a concise structured 10-day protocol.

One-year experience of hybrid closed-loop system in children and adolescents with type 1 diabetes previously treated with multiple daily injections: drivers to successful outcomes

“…This observational study confirms the potential of HCL systems to improve overall glycemic control [19,20]. The 12 months observational results provide evidence for the sustainability of these results beyond the initial 3-month period reported previously [12] and are superior to previously reported outcomes in children [9] and adolescents [11]. The improved HbA1c in our study after 3 months remained stable in the long term with 7.1 ± 0.6% (54 ± 6.6 mmol/ mol) at 1 year, compared to 7.6 ± 0.8 (60 ± 8.7 mmol/mol) at 1 year [16] and 7.2 ± 0.1 (55 ± 1.1 mmol/mol) at 6 months of HCL initiation [14] in previous reports.…”

“…All 30 individuals enrolled in the 3-month prospective study [12] completed 1-year usage of the MiniMed 670G system with Auto Mode, and no attrition was observed, compared to 46% of participants, who stopped using the Auto Mode in the 1-year period reported by Lal et al [16] and 19% discontinuation rate after 8 months, reported by Godwin et al [18]. This can be partly due to the low number of Auto Mode exits, averaged 4.7 ± 2.0 per patient per week during the 12-month period, similar to 4.8 ± 1.6 exits at 3 months [9], which indicates that the participants were educated appropriately, and the system settings were optimized to reduce exits thus the system use became more comfortable over time.…”

“…The patient selection, the educational process, as well as the 10-day initiation protocol for the MiniMed 670G HCL system were previously reported [12]. In short, the 10-day initiation protocol consisted of four main stages: Step 1-HCL system compatibility assessment: two 1 h introduction sessions in groups of 8-12 patients, where the MiniMed 670G system was described and individuals' responsibilities and expectations were discussed; Step 2-HCL system training: five sessions of 2 h on five consecutive days in groups of 3-5 patients, where CGM was initiated the first day of the training for education and observational purposes and the pump was used as a monitor (insulin delivery with injections); Step 3-Manual Mode: HCL system initiation in Manual Mode for 72 h; Step 4-Auto Mode: HCL system initiation and used continuously for 3 months.…”

“…Glycemic outcomes in the pediatric age have been traditionally lower, while the causes are not clear and the underlying causes are to be defined. Three-month observational study [12] has shown that children and adolescents with T1D on MDI therapy without prior pump experience can successfully initiate the HCL system, using a concise structured 10-day protocol and achieve better glycemic outcome than previous treatment with MDI. Another study on the HCL system in children and youth with T1D shows that glycemic control is improved with Auto Mode use when measured by percent TIR, SG and HbA1c during the 6 months follow-up [13].…”

Successful Initiation of Hybrid Closed-Loop System Using Virtual Pump Training Program in a Teenager With Type 1 Diabetes Previously Treated with Multiple Daily Injections

“…2 Telemedicine can be also used safely and effectively for new-onset T1D training and education for both pediatric and adult patients and their families. 3 Due to the COVID-19 restrictions in providing regular diabetes services at Sidra Medicine in Qatar, the traditional training and education, a 10-day initiation protocol 4 for hybrid closed-loop (HCL) system in patients previously treated with multiple daily injections (MDI) was postponed, as the service was not considered critical in the current situation. In an attempt to continue to support CSII initiation, the diabetes team developed an innovative "virtual pump training program," based on the previous initiation protocol for the HCL system, 4 using video conferencing Skype "Meet Now" (Skype Communications S.a.r.l., Palo Alto, CA, USA).…”