Background and Aims

Healthcare professional (HCP) engagement with do-it-yourself automated insulin dosing (DIY AID) systems is variable with no clear guidelines or liability clarification if they choose to do so. We conducted qualitative interviews to examine the HCP perspective on these systems and their impact on routine healthcare.

Methods

Twenty healthcare professionals were interviewed from adult and paediatric diabetes services. HCP interviews explored perceptions of DIY AID systems, facilitators, and barriers to supporting such systems with patients and views on what would be required for the systems to be integrated into routine healthcare if safety and efficacy could be proven.

Results

HCPs reported benefits including glycaemic improvements (n=13), being safer than or presenting no added risk compared to other diabetes technologies and management approaches (n=12) and customizability (n=9). HCPs described the primary barriers to supporting DIY AID use as uncertainty about liability issues (n=19) and lack of formal guidelines regarding DIY AID systems in clinical practice (n=19). The majority of HCPs discussed reviewing data or collaborating with patients using DIY systems. Approximately half of HCPs reported making efforts to learn about DIY systems from patients, colleagues, or online resources.

Conclusions

We provide useful data about the complexities of the HCP and DIY AID user relationship as well as factors involved in HCP decisions about whether to support patients using these systems. HCP decision-making appears to be more nuanced than supporting or not supporting DIY use, with HCPs describing varying degrees of support for patients’ DIY systems.

Background and Aims

Despite increasing use of Open-Source Automated Insulin Delivery (OS-AID) systems and real-world outcomes demonstrating safety and efficacy, there is no professional guidance available for HCPs to support use or provide clarity on ethical and legal concerns. As a result, a lot of uncertainty remains in care teams around the world on how to support people with diabetes using OS-AID. Therefore, an international professional consensus statement and practical guidance review is urgently needed.

Methods

As part of the OPEN project, a steering committee comprising of HCPs (endocrinologists, educators, exercise physiologists and psychologists) with significant clinical experience in OS-AID and publication track record was formed to develop the guidance. An international group of clinicians across several global regions formed part of a larger HCP network and contributed to the wider consensus of this guidance using an online feedback system. Input was also provided by medico-legal experts.

Results

Since the initial meeting at ATTD 2020, the steering committee has met virtually over 12 times. A review strategy was devised (see figure) and up-to-date best practice guidance and consensus statement were drafted using a real-time collaboration tool. The current final version is being appraised by the wider HCP network and major professional diabetes organisations on a multinational level.

Conclusions

Our detailed consensus finds OS-AID satisfies the principles of medical ethics and there is sufficient observational data supporting its safety and efficacy. It provides best practice recommendations for HCPs. Furthermore, it highlights important recommendations for regulators and industry.

Background and Aims

We evaluated the feasibility and safety of the interoperable artificial pancreas system (iAPS) utilizing zone model predictive control in a pediatric outpatient study (NCT04255381).

Methods

Pediatric subjects (n=20, 8F) with type 1 diabetes completed 48 hours of automated insulin delivery (AID) using the iAPS on an unlocked smartphone in three sequential age-based cohorts: 12-<18 years (n=8, 5F), 8-<12 years (n=7, 2F) and 5-<8 years (n=5, 1F). Subjects consumed larger-than-usual meals of their choice and engaged in unannounced physical activities such as escape room, trampoline park and ropes course. Primary outcomes using fingerstick blood glucose (BG) assessed safety while secondary outcomes using continuous glucose monitoring (CGM) compared performance with sensor augmented pump (SAP) preceding AID.

Results

During AID, there were no instances of more than one confirmed BG < 50 mg/dL, two instances of more than two confirmed BG ≥ 300 mg/dL longer than 2 hours, and no adverse events. Overnight during AID (Table), the low blood glucose index decreased by 0.3 (p=0.006) and glucose variability decreased by 14.9 mg/dL (p=0.009). In the youngest cohort, percent time in 70-140 mg/dL range increased by 12.2% (p=0.015). Pre-pubertal subjects (1F) were significantly more sensitive to exercise-induced glycemic changes (Figure).

Table. Comparison of outcomes (mean (standard deviation)) during iAPS AID over SAP for all subjects. ‡ indicates p < 0.05.

Figure. Pre-pubertal (Tanner I) vs pubertal/post-pubertal (Tanner II-V) during physical activities.

Conclusions

The smartphone-based iAPS AID system was feasible and safe in pediatric subjects, even with larger meals and unannounced physical activities.

Background and Aims

Clinical trials of the AHCL system demonstrated improved glycemic outcomes.^1,2,3 An exploratory analysis investigated how early optimum control was reached in pediatric and adult participants of the MinMed™ AHCL pivotal trial.

Methods

Participants underwent baseline run-in (~2 weeks) with HCL, SAP or CSII therapy followed by a 3-month study phase with the AHCL automated basal and autocorrection bolus therapy. Glycemic outcomes of the run-in and study were compared (including the months 1, 2, and 3 of the study phase) to determine how long it takes to reach glycemic stability and its duration of sustainability.

Results

Tables 1 and 2 show glycemic data for the run-in period, end-of-study phase and months 1, 2, and 3 of the study phase for the pediatric and adult cohorts, respectively. Significant change in mean sensor glucose was observed from run-in to end-of-study and run-in to month 1. Thereafter, no significant changes were observed.

Conclusions

These data suggest that glycemic outcomes in the first month of AHCL use may predict the subsequent two months and permit a shorter time to determine the effectiveness of AHCL in individual patients.

Background and Aims

Modern automated insulin delivery system (AID), relying on timely quantification of meals, have reliably improved glycemic control in people with Type 1 Diabetes (T1D) of all ages. Achieving similar control without meal information has so far proven elusive. We present a new generation closed loop control (CLC) algorithm designed for such use.

Methods

Adolescents with T1D were enrolled at the UVA Center for Diabetes Technology (CDT) in a supervised outpatient clinical trial comparing the legacy UVA CLC (USS) with our new algorithm (RCKT) during hybrid (HCL) and fully automated (FCL) use. Four 24h periods were studied with 3 meals repeated from day to day; the second and fourth dinner were unannounced. One algorithm was used for day 1-2 and the other for day 3-4, in random order. Glucose control was evaluated on standard CGM-based metric.

Results

Twenty-one adolescent participants signed consent at CDT. Eighteen completed the study. Time in range (TIR) overall was 79.1±11.4% vs 83.2±10.8 (p=0.22) with dinner bolus and 78.6±11.1% vs 84.5±7.4% (p=0.075) without, for USS and RCKT respectively. Focusing on dinner (6PM-midnight) TIR in HCL was 90.9±12.9% vs 97.8±5.7%, p=0.052, and 58.8±25.7% vs 77.0±22.6%, p=0.02, in FCL. There was no difference in time below 70mg/dL or occurrence of hypoglycemia.

Conclusions

Our new AID algorithm was shown to be feasible in adolescents with T1D, equivalent to UVA legacy algorithm in hybrid use, and led to +18% TIR during un-bolused dinners. Additional studies are needed to assess its impact over several days of use and less supervised environments.

Background and Aims

Glucose control in patients with diabetes after total pancreatectomy (TP) is problematic due to complete absence of both pancreatic alpha and beta cells. Recently, a novel bihormonal (insulin and glucagon) artificial pancreas (AP) for closed loop glucose control showed better glucose control compared to standard insulin pump therapy in patients with diabetes type 1. This AP system might also improve glucose control in patients after TP.

The aim is to assess the efficacy and safety of the bihormonal AP in patients after TP.

Methods

This trial was an outpatient, randomized, crossover trial comparing AP therapy to current care (insulin pump or pen therapy). The outcomes in both phases were analyzed during a total of 7 days. The AP closed loop phase was preceded by a 5-day training period. Primary outcome was the time spent in euglycemia (3.9-10 mmol/L or 70–180 mg/dL).

Results

A total of 10 patients were included in the analysis. In the AP closed loop phase, the time spent in euglycemia was significantly higher (78.3% [IQR 72.3-81.7] vs 57.4% [IQR 54.1-80.2], p=0.027), as compared to current care. Also, the AP showed a significant lower time spent in hypoglycemia (0% [IQR 0.0-0.0] vs 1.6% [IQR 1.0-2.8]), p=0.004). No serious adverse events related to the AP device were seen.

Conclusions

This small randomized crossover trial showed that an artificial pancreas bihormonal closed loop system is safe and significantly improves time in euglycemia as compared to current practice of insulin pump or pen injections. Larger randomized trials including longer periods of treatment are needed.