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

Acta Diabetol. 2019 Jun;56(6):667-673. doi: 10.1007/s00592-019-01300-1. Epub 2019 Feb 19.

Abstract

Aim: To 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.

Methods: 74 T1D patients on insulin pumps for at least 1 year (mean 19.5 [11.5] years) and HbA1c ≥ 6.5% (≥ 48 mmol/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 3 months for the standard care group. Satisfaction with treatment, quality of life and frequency of hypoglycemic events was evaluated.

Results: The mean changes in HbA1c adjusted to baseline were - 0.08% (0.25 mmol/mol) vs. - 0.01% (0.03 mmol/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.

Conclusions: Internet-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 registration: Clinical Trial.gov Identifier NCT01887431.

Keywords: Internet-based therapeutic intervention; Telemedicine; Type 1 diabetes mellitus; Young adults.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Blood Glucose Self-Monitoring / instrumentation
  • Blood Glucose Self-Monitoring / methods*
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Female
  • Humans
  • Hypoglycemic Agents / administration & dosage*
  • Hypoglycemic Agents / therapeutic use
  • Insulin / administration & dosage*
  • Insulin / therapeutic use
  • Insulin Infusion Systems*
  • Internet
  • Male
  • Middle Aged
  • Telemedicine / methods*

Substances

  • Hypoglycemic Agents
  • Insulin

Associated data

  • ClinicalTrials.gov/NCT01887431