The first study conducted on the Omnipod Horizon System that explores the effectiveness and safety parameters.
The Omnipod 5, Powered by Horizon System, is a hybrid closed loop automated insulin delivery device. This system is compatible with the Dexcom G6 sensor. A mobile phone or personal diabetes manager is used to switch to automatic mode, administer bolus doses, and control different settings. A unique feature of the device is that it uses custom-built glucose control. The precise targets implanted ranged from 110 to 150 mg d/L. These targets are modifiable based on the time of day. Another beneficial feature of this device is called “Hypo Protect,” which prevents the patient from experiencing a hypoglycemia episode. Exercising is an excellent example of when this feature is being activated. This device better improves a patient’s glycemic control over time because it learns the patient’s insulin delivery schedule. Previous relevant studies were done using a prototype device. This prototype provided the research that this device was safe based on 193 patients no younger than two years old.
This multicenter single-arm outpatient study’s objective was to measure this device’s safety and effectiveness in a patient’s entire body with type 1 diabetes for 14 days. Before the hybrid closed loop phase, a baseline standard therapy phase was conducted. The hybrid closed-loop phase was conducted over winter break. The patients were allowed to have a free diet and exercise regimen. In this study design, only data from the children from the ages of 6 to 13.9 years was used. Patients had have type 1 diabetes longer than six months and an A1C of less than 10% to be included in the study. The breakdown of the hybrid closed loop phase was first a glucose target of 130 mg/dL for the first three days, 140 mg/dL for the next three days, and 150 mg/dL for days 7-9. For the last five days, patients were free to choose their target ranging from 110-150 mg/dL. During the 5 day free-choice period, 69% choose target of 110 mg/dL, 10% choose 120 mg/dL, 21% choose 130 mg/dL. According to the researchers, all the participants were asked to complete the pivotal study for three months. The measure’s primary effectiveness outcome was the glucose percentage of time within the target range for the hybrid closed loop phase compared to the standard therapy phase. The primary safety outcome of the measure was the number of patients who experienced device-related adverse effects. The study population included both adults and children between the ages of 6 to 70 years old. Based on 78% of patients’ data during Christmas and New Year’s, patients had an obvious decline in the amount of time spent in target levels. The statistical test used when compared to the standard therapy was a paired t-test.
The number of participants included in the standard deviation results was 15. The mean glucose measured in mg/dL for the targets were 130 (171 ± 11), 140(174 ± 18), 150 (185 ± 17) and free choice (168 ± 18). The percentage of time results were: <54 mg/dL were 130 (0.2 ± 0.5), 140(0.01 ± 0.03), 150 (0.03 ± 0.10) and free choice (0.1 ± 0.3), <70 mg/dL 130 (1.0 ± 1.2), 140(0.6 ± 1.2), 150 (0.6± 0.9) and free choice (0.9 ± 1.2), 70 – 180 mg/dL 130 (63.4 ± 7.9), 140(64.2 ± 11.6), 150 (52.1 ± 11.7) and free choice (64.1 ± 10), >180 mg/dL 130 ( 35.6 ± 8.0), 140(35.3 ± 12.1), 150 (47.3 ± 11.7) and free choice (34.9 ± 10.9), ≥250 mg/dL 130 ( 11.6 ± 5.5), 140(10.8 ± 7.7), 150 (13.7 ± 9.4) and free choice (11.3 ± 7.1). The time in automated mode in percentage was (97.2 ± 4.7) for target glucose and (97.9 ± 1.7) for free choice. Luckily, no serious adverse effects were reported during this study. Only one patient had an infection at the site of injection. When compared to standard therapy the results for time in hypoglycemic range was <54 mg/dL (p<0.05) and <70 mg/dL (p<0.05). Hyperglycemic range results were >180 mg/dL (p<0.05) and ≥250 mg/dL (10.2 ± 11.8). The time spent in target range was 71.6 ± 19.7 (p<0.01).
This study was conducted under tense circumstances during the winter holidays. During this time, children are not always supervised and may receive excess foods high in sugar and carbohydrates. However, it was still determined that the Omnipod Horizon Hybrid Loop System was safe in children with type 1 diabetes for the last five days of the study.
- It is important to modify diabetes management strategies for patients because the individual will have different requirements.
- The patient’s time in the glucose target steadily improved with prolonged use.
- Children can have profound favorable results in glycemic control if they implement the Omnipod Horizon System.
Forlenza G, Buckingham B, Criego A, Brown S, Bode B, Levy C. First Home Evaluation of the Omnipod 5 Automated Insulin Delivery System, Powered by Horizon in Childen with Type 1 Diabetes. EASD Virtual Congress. Published in 2020. Accessed October 3, 2020. https://www.easd.org/virtualmeeting2020/#!resources/first-home-evaluation-of- the-omnipod-horizon-automated-glucose-control-system-in-children-with-type-1-diabetes
Alexandria Bartley, PharmD. Candidate, Florida Agricultural & Mechanical University, College of Pharmacy and Pharmaceutical Sciences