JMIR Publications

ABSTRACT

Background:

Type 2 diabetes mellitus is a chronic disease whose health outcomes are related to patients and healthcare professionals’ decision-making.

Objective:

To assess the effectiveness of internet- based multicomponent interventions to support decision-making of all actors involved in the care of patients with type 2 diabetes mellitus in primary care.

Methods:

The INDICA study is an open, community-based, multicenter trial with random allocation to usual care (UC), or intervention for patients (PTI), healthcare professionals in primary care (PFI) or for both (CBI). Patients in PTI received an educational group program were monitored and supported by means of logs, a web-based platform and automated short messages service. Professionals in PFI also received an educational program, a decision support tool embedded into the electronic clinical record and periodic feedback about patients’ results. A total of 2,334 people with type 2 diabetes mellitus, regardless of HbA1c levels and without diabetes-related complications were included. The primary endpoint was change in HbA1c. The main analysis was performed using multilevel mixed models.

Results:

For the overall sample, the PTI attained a significant mean HbA1c reduction at month 3 of ‒0.27 and at month 6 of ‒0.26 compared to UC that remained marginally significant at month 12. A clinically relevant reduction of HbA1c was observed in 35.6% of PTI patients and 26.0% of those in UC at month 12 (P=0.006). In CBI, HbA1c reduction was significant until month 18 (32.6% vs 23.9%). Considering the subgroup of patients uncontrolled in baseline, all interventions produced significant reductions of HbA1c across the entire study period (‒.49 for PTI, ‒.35 for PFI and ‒.35 for CBI). Differences of HbA1c for the area under the curve (AUC) considering the entire period were significant for PTI and CBI compared to UC. Compared to UC, patients in PFI and CBI had significantly longer-term reductions of systolic and diastolic blood pressure.

Conclusions:

The PTI intervention for uncontrolled patients at baseline, provided clinically relevant and significant longer-term reductions of HbA1c. PFI and CBI also improved the cardiovascular risk profile of patients. Clinical Trial: ClinicalTrials.gov NCT01657227; https://clinicaltrials.gov/ct2/show/NCT01657227 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT01657227)