A simple phone call may help millions with diabetes manage insulin — a trial puts it to the test

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years or older. * Diagnosed with type 2 diabetes mellitus. * Currently receiving basal insulin or considered by the treating clinician to require initiation or adjustment of basal insulin. * Glycemic control considered inadequate and requiring basal insulin titration according to the study protocol. * Low health literacy as determined using the study-approved screening method. * Able to communicate in one of the languages supported by the study intervention. * Has access to a functioning feature phone or mobile telephone and is able to receive automated voice calls. * Able and willing to perform fasting blood glucose monitoring according to the study procedures. * Willing and able to provide informed consent. * Willing to comply with study procedures and complete the 12-week follow-up. Exclusion Criteria: * Type 1 diabetes mellitus, gestational diabetes, or another specific form of diabetes other than type 2 diabetes mellitus. * Pregnancy, current breastfeeding, or planned pregnancy during the study period. * Current use of an insulin pump. * Severe hypoglycemia requiring assistance from another person within the period specified in the protocol before enrollment. * Recurrent hypoglycemia or another clinical condition that, in the investigator's judgment, makes protocol-directed insulin titration unsafe. * Acute metabolic decompensation, including diabetic ketoacidosis or hyperosmolar hyperglycemic state, at screening or within the period specified in the protocol. * Severe renal, hepatic, cardiac, psychiatric, cognitive, hearing, or other medical impairment that would prevent safe participation or completion of the voice-call intervention. * Inability to understand or respond to the study's supported voice-call languages. * Inability to use the telephone or glucose-monitoring procedures, with or without assistance permitted by the protocol. * Current participation in another interventional clinical trial that could interfere with the study outcomes. * Any other condition that, in the investigator's judgment, would make participation unsafe or compromise adherence to the study procedures.