Real-World Evidence Shows Automated Insulin Dosing Safe, Effective Treatment for T1D

Katarina Braune, MD

Although meeting recommended glycemic targets remains a challenge for patients with type 1 diabetes (T1D), the development of automated insulin dosing (AID) systems may represent an improvement in diabetes management. Accordingly, a recent study performed a systematic review to summarize real-world evidence on commercial and open-source AID systems.

Led by Katarina Braune, MD, Berlin Institute of Health and Sufyan Hussain, Department of Diabetes, King’s College London, a team of investigators determined that commercially developed and open-source AID systems are effective and safe treatment options for patients with diabetes.

Methods

The duo and their team searched electronic databases including Pubmed, MEDLINE, Embase, CINAHL, Cochrane Database of Systematic Reviews, and the Central Register of Controlled Trials from the inception to June 2021.

For determining inclusion, investigators used original research articles, focused on single-hormone AID systems (commercially developed and open-source). Additionally, participants in the trial were required to have T1D, with endpoints related to glycemic outcomes and self-reported data or observational studies.

Then, primary endpoints focused on the effectiveness and safety of AID systems were identified as the percentage Time-in-Range (TIR; 70 - 180 mg/dL, 3.9 - 10.0 mmol/L), change in TIR, and HbA1c.

Secondary outcomes included the incidence of hypoglycemia, defined as Time-Below-Range (TBR; <70 mg/dL/3.9 mmol/L) and the reported occurrence of severe hypoglycemia, diabetic ketoacidosis (DKA), or other serious adverse events.

Findings

Initially, investigators identified 441 studies, of which 88 potential publications were retrieved in full-text. Then, investigators found 21 publications that met the inclusion criteria, with 7,083 participants eligible for further analysis.

Out of the total, 12 were for Medtronic 670G, 1 for Tandem Control-IQ, 1 for Diabeloop DBLG1, 2 for AndroidAPS, 1 for OpenAPS, 1 for Loop, and 3 comparing various types of AID systems. Additionally, the majority were observational studies, with 11 evaluating data retrospectively and 10 prospectively.

Then, results from studies covering a total number of 4054 participants based in 5 countries and using 1 of 3 commercial AID systems were analyzed.

Investigators noted that 10 of 12 studies evaluating the real-world use of the Medtronic 670G found significant improvement in TIR, while 5 reported significant improvement in HbA1c. In a population of 79 patients in a 1-year prospective observational study of US participants, there was a significant correlation between change in HbA1c and auto-mode use at all visits (P = .036). 

Further, in the DBLG1 system, the investigators reported on 25 patients with T1D aged >22 years demonstrated improvements in TIR from 53.0±16.4% to 69.7% (P < .0001) and reduction in HbA1c from 63±-14 to 54 mmol/mol (7.9±0.9% to 7.1% (P < .001).

For OpenAPS, the average TIR of the cohort of 80 patients was 77.5 ± 10.5% during the first 180 days. In a subcohort of 34 patients, there was a significant reduction in estimated HbA1c from 49 ± 14 to 44 ± 17 mmol/mol (6.6 ± 0.9% to 6.2 ± 0.6%; P < .0001) and an increased TIR from 71.1±13.5% to 80.4±8.3% (P < .0001).

Overall, investigators noted that several types of AID systems improved TIR and HbA1c with minimal concerns around severe hypoglycemia.

Takeaways

Braune and Hussain noted that real-world studies on AID systems, along with their effects on glycemic outcomes are a beneficial tool in evaluating their safety and effectiveness.

“Further research should address usability and human factors as well as difficulties in access to AID in real-world settings and how potential barriers to auto-mode use could be resolved to enable PwD to stay in treatment,” investigators wrote.

The study, “Real-world Evidence on Clinical Outcomes of People with Type 1 Diabetes Using Open-Source and Commercial Automated Insulin Dosing Systems: A Systematic Review,” was published in Diabetic Medicine.