This protocol applies to people with type 1 diabetes who have been managed with standard insulin replacement therapy — including continuous glucose monitoring — yet have not achieved the required glycaemic targets. It defines the clinical escalation step that follows that failure.
The previous treatment line consisted of insulin replacement designed to mimic physiological secretion, using either multiple daily injections (MDI) or continuous subcutaneous insulin infusion via an insulin pump, with continuous glucose monitoring (CGM). That regimen was considered to have failed when the following goals were not met:
The recommended approach centres on intensifying insulin delivery. For those on a less-intensive injection regimen, this means escalating the injection schedule. For suitable candidates already on injection therapy, the protocol describes a switch to a more advanced form of automated insulin delivery — including hybrid closed-loop technology, which carries the strongest evidence for maintaining glucose within the normal range in type 1 diabetes. The full eligibility criteria, decision pathway, and sequencing are set out in the complete protocol.
DOI: 10.2337/dci21-0043