Trial results for the MiniMed™ 780G System in Type 1 Diabetes were posted on ClinicalTrials.gov on 2025-06-22, showing adults achieved a mean Time in Range (TIR) of 77.1%.
Background
Type 1 Diabetes is an autoimmune condition characterized by the pancreas's inability to produce insulin, necessitating lifelong insulin therapy. Effective management of blood glucose levels is paramount to mitigate both acute complications, such as hypoglycemia and hyperglycemia, and chronic complications affecting various organ systems, including the eyes, kidneys, nerves, and heart. Glycemic control is traditionally assessed by HbA1c, which provides an average blood glucose level over several months. Increasingly, Time in Range (TIR), representing the percentage of time blood glucose remains within a target range (typically 70-180 mg/dL), is recognized as a crucial metric for assessing daily glucose management. Automated insulin delivery (AID) systems, like the MiniMed™ 780G, are designed to streamline diabetes management by continuously monitoring glucose levels and automatically adjusting insulin delivery, aiming to improve TIR and reduce HbA1c while minimizing hypoglycemic events. The integration of faster-acting insulins, such as Fiasp, can further enhance the system's ability to respond to glucose fluctuations.
Trial design
This completed study, designated as Phase NA, enrolled 240 participants across the US, Canada, and Australia. The trial evaluated the safety and effectiveness of the MiniMed™ 780G system in adult and pediatric subjects with Type 1 Diabetes, specifically when utilizing Fiasp (insulin aspart injection) in a home setting.
Key results
The trial reported several key measurements and analyses for both pediatric and adult participants:
- Primary Safety Endpoint - Change in HbA1c
- For Subjects 7-17 Years of Age, the mean change in HbA1c was -0.2 percentage points (Standard Deviation 0.7). Analysis showed a mean difference from baseline to exit of -0.2 (95.0% CI: -0.4 to -0.1), with a p-value of 0.001.
- For Subjects 18-80 Years of Age, the mean change in HbA1c was -0.4 percentage points (Standard Deviation 0.6). Analysis showed a mean difference from baseline to exit of -0.4 (95.0% CI: -0.5 to -0.2), with a p-value of 0.001.
- Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
- For Subjects 7-17 Years of Age, the mean percentage of Time in Range was 65.7 (Standard Deviation 11.3). Analysis showed a mean of final value of 65.7 (95.0% CI: 63.5 to 67.9), with a p-value of 0.001.
- For Subjects 18-80 Years of Age, the mean percentage of Time in Range was 77.1 (Standard Deviation 9.6). Analysis showed a mean of final value of 77.1 (95.0% CI: 75.4 to 78.9), with a p-value of 0.001.
- Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])
- For Subjects 7-17 Years of Age, the mean percentage of Time in Hypoglycemia was 0.3 (Standard Deviation 0.3). Analysis showed a mean of final value of 0.3 (95.0% CI: 0.3 to 0.4), with a p-value of 0.001.
- For Subjects 18-80 Years of Age, the mean percentage of Time in Hypoglycemia was 0.3 (Standard Deviation 0.4). Analysis showed a mean of final value of 0.3 (95.0% CI: 0.2 to 0.4), with a p-value of 0.001.
What this means
The posted trial results indicate that the MiniMed™ 780G System, when used with Fiasp insulin, demonstrated favorable outcomes in glycemic control for individuals with Type 1 Diabetes across both pediatric and adult age groups. The observed reductions in HbA1c and significant increases in Time in Range, particularly for adults, suggest the system's effectiveness in maintaining blood glucose within target levels. Furthermore, the consistently low percentages of time spent in hypoglycemia across both cohorts highlight the system's safety profile in minimizing severe low blood sugar events. These findings support the potential of this automated insulin delivery system to improve daily diabetes management in a home setting.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05224258, titled "Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®", were posted on 2025-06-22 on clinicaltrials.gov.