Trial results for a feasibility study evaluating the Tandem Freedom system in adults with Type 1 Diabetes were posted on ClinicalTrials.gov on 2026-02-06, reporting no participants experienced severe hypoglycemia or diabetic ketoacidosis events.
Background
Type 1 Diabetes is a chronic autoimmune condition requiring lifelong insulin management. Advanced insulin delivery systems, such as automated insulin delivery (AID) systems, aim to improve glycemic control and reduce the burden of disease management. These systems continuously monitor glucose levels and automatically adjust insulin delivery, helping to prevent both hyperglycemia and hypoglycemia. The Tandem Freedom system represents an evolution in this technology, building upon existing Control-IQ technology to potentially offer enhanced safety and efficacy for individuals managing their condition.
Trial design
This completed feasibility study, identified as Phase NA, enrolled 10 participants with Diabetes Mellitus, Type 1. The study was a prospective, single-arm design evaluating the Tandem Freedom system in adults. Participants who were existing Control-IQ technology users first used Control-IQ technology at home for a one-week run-in period, then transitioned to using the Tandem Freedom system in a supervised hotel setting.
Key results
The trial results focused on safety and glycemic control metrics for the Tandem Freedom system:
- The number of participants with one or more severe hypoglycemia events was 0.
- The number of participants with one or more diabetic ketoacidosis events was 0.
- Median percent time <54 mg/dL was 0.0 percentage of time.
- Median percent time <70 mg/dL was 0.4 percentage of time.
- Median percent time in range 70 - 180 mg/dL was 61.0 percentage of time.
- Median percent time in range > 180 mg/dL was 38.2 percentage of time.
What this means
The posted results from this feasibility study suggest that the Tandem Freedom system may offer a favorable safety profile, with 0 reported severe hypoglycemia or diabetic ketoacidosis events among the 10 participants. The glycemic control metrics, including a median time <54 mg/dL of 0.0 percent and a median time in range (70-180 mg/dL) of 61.0 percent, indicate effective glucose management. These preliminary findings support the continued development and evaluation of the Tandem Freedom system as a potential advancement in automated insulin delivery technology for individuals with Type 1 Diabetes, building on the foundation of existing Control-IQ technology.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06834568, titled "Tandem Freedom - Feasibility Trial 2", were posted on 2026-02-06 on clinicaltrials.gov.