A randomized controlled trial comparing a telemedicine therapeutic intervention with routine care in adults with type 1 diabetes mellitus treated by insulin pumps

AimTo examine the effectiveness and safety over a 12-month period of a telemedicine intervention in adults with type 1 diabetes (T1D) treated with insulin pumps.Methods74 T1D patients on insulin pumps for at least 1 year (mean 19.5 [11.5] years) and HbA1(c)6.5% (48mmol/mol) were randomized to the telemedicine (n=37) or the standard care group (n=37). The intervention group was instructed to download data from insulin pumps and glucometers monthly. They received immediate phone feedback and recommendations for insulin dose adjustment; and face-to-face visits once in 6 months, compared to once every 3months for the standard care group. Satisfaction with treatment, quality of life and frequency of hypoglycemic events was evaluated.ResultsThe mean changes in HbA1c adjusted to baseline were -0.08% (0.25mmol/mol) vs. -0.01% (0.03mmol/mol), in the intervention and control groups, respectively (p=0.18) at 12 months, without an increased frequency of hypoglycemia. Patients in the intervention group felt satisfied and interested in continuing with the treatment (p=0.04). The quality of life scores were similar in both groups. Direct total costs were 24% less in the intervention group, and indirect total costs decreased by 22% compared to the year preceding the study.ConclusionsInternet-based insulin dose adjustment is as effective and safe as routine care in adults with type 1 diabetes treated by insulin pumps. For suitable patients, some of the time-consuming routine visits may be replaced by user-friendly digital medicine.Clinical trial registrationClinical Trial.gov Identifier NCT01887431.