Trial results for the Tandem Freedom system in adults with Type 1 Diabetes were posted on 2025-11-18, showing no severe hypoglycemia or diabetic ketoacidosis events among the 10 participants.
Background
Type 1 diabetes requires constant management of blood glucose levels to prevent acute complications like hypoglycemia and diabetic ketoacidosis, as well as long-term complications. Advanced insulin delivery systems, such as automated insulin delivery (AID) systems, aim to reduce the burden of management and improve glycemic outcomes. The Tandem Freedom system is being evaluated as a potential advancement in this area, building on existing technologies like Control-IQ.
Trial design
This completed feasibility study, identified as Phase NA, enrolled 10 adult participants with Type 1 Diabetes. It was a prospective, single-arm study evaluating the Tandem Freedom system. Participants, who were existing Control-IQ technology users, first used Control-IQ at home for a one-week run-in period, then used Tandem Freedom in a supervised hotel setting. The study aimed to assess the feasibility and safety of the Tandem Freedom system.
Key results
The trial reported the following key measurements:
- For participants using the Tandem Freedom Algorithm, there were 0 severe hypoglycemia events.
- Similarly, 0 diabetic ketoacidosis events were reported.
- The median percent time with glucose levels below 54 mg/dL (Percent Time <54 mg/dL) for the Tandem Freedom system was reported as 0.1%, 0.0%, and 0.0%, with Inter-Quartile Range.
- The median percent time with glucose levels below 70 mg/dL (Percent Time <70 mg/dL) for the t:slim X2 insulin pump with Tandem Freedom Algorithm was reported as 1.3%, 1.4%, and 0.0%, with Inter-Quartile Range.
What this means
The results from this feasibility study suggest that the Tandem Freedom system may offer a safe profile for adults with Type 1 Diabetes, as indicated by the absence of severe hypoglycemia and diabetic ketoacidosis events. The very low median percentages of time spent in hypoglycemia (below 54 mg/dL and 70 mg/dL) are also encouraging, suggesting effective glucose management. These preliminary findings, from a small cohort of 10 participants, indicate the system's potential to maintain glycemic control while minimizing critical adverse events. Further research in larger trials would be needed to confirm these benefits and assess long-term efficacy and safety.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06428591, titled "Tandem Freedom Feasibility Study 1", were posted on 2025-11-18 on clinicaltrials.gov.