COYOTE Study
Cross-source consensus on COYOTE Study from 1 sources and 8 claims.
1 sources · 8 claims
Comparisons
Evidence quality
Other
Other
Highlighted claims
- The COYOTE study is an open-label, multinational, multicentre, randomised, single-period parallel trial. — Assessing the efficacy, safety and utility of fully closed-loop insulin delivery compared to standard insulin therapy with a continuous glucose monitor in adults with type 2 diabetes (COYOTE study): a randomised parallel study protocol
- The study compares fully closed-loop insulin delivery against standard insulin therapy with CGM over a 26-week intervention period. — Assessing the efficacy, safety and utility of fully closed-loop insulin delivery compared to standard insulin therapy with a continuous glucose monitor in adults with type 2 diabetes (COYOTE study): a randomised parallel study protocol
- Twelve clinical sites participate across six countries. — Assessing the efficacy, safety and utility of fully closed-loop insulin delivery compared to standard insulin therapy with a continuous glucose monitor in adults with type 2 diabetes (COYOTE study): a randomised parallel study protocol
- Total enrolment was scaled to 224 participants to accommodate an expected 20% dropout rate and enable robust safety and feasibility assessment. — Assessing the efficacy, safety and utility of fully closed-loop insulin delivery compared to standard insulin therapy with a continuous glucose monitor in adults with type 2 diabetes (COYOTE study): a randomised parallel study protocol
- All randomised participants are analysed under the intention-to-treat principle, including protocol violators, dropouts, and withdrawals. — Assessing the efficacy, safety and utility of fully closed-loop insulin delivery compared to standard insulin therapy with a continuous glucose monitor in adults with type 2 diabetes (COYOTE study): a randomised parallel study protocol
- The open-label design means neither participants nor clinicians are blinded to treatment allocation. — Assessing the efficacy, safety and utility of fully closed-loop insulin delivery compared to standard insulin therapy with a continuous glucose monitor in adults with type 2 diabetes (COYOTE study): a randomised parallel study protocol
- Randomisation not being stratified by insulin regimen type may cause imbalance between groups and introduce confounding. — Assessing the efficacy, safety and utility of fully closed-loop insulin delivery compared to standard insulin therapy with a continuous glucose monitor in adults with type 2 diabetes (COYOTE study): a randomised parallel study protocol
- Broad inclusion and limited exclusion criteria support the generalisability of findings. — Assessing the efficacy, safety and utility of fully closed-loop insulin delivery compared to standard insulin therapy with a continuous glucose monitor in adults with type 2 diabetes (COYOTE study): a randomised parallel study protocol