The Diabetes Telemonitoring Study Extension: an exploratory randomized comparison of alternative interventions to maintain glycemic control after withdrawal of diabetes home telemonitoring

Abstract

Background: Telemonitoring interventions featuring transmission of home glucose records to healthcare providers have resulted in improved glycemic control in patients with diabetes. No research has addressed the intensity or duration of telemonitoring required to sustain such improvements.

Purpose: The DiaTel study (10 January 2005 to 1 November 2007) compared active care management (ACM) with home telemonitoring (n=73) to monthly care coordination (CC) telephone calls (n=77) among veterans with diabetes and suboptimal glycemic control. The purpose of the DiaTel Extension was to assess whether initial improvements could be sustained with interventions of the same or lower intensity among participants who re-enrolled in a 6-month extension of DiaTel.

Methods: DiaTel participants receiving ACM were re-assigned randomly to monthly CC calls with continued telemonitoring but no active medication management (ACM-to-CCHT, n=23) or monthly CC telephone calls (ACM-to-CC, n=21). DiaTel participants receiving CC were re-assigned randomly to continued CC (CC-to-CC, n=28) or usual care (UC, ie, CC-to-UC, n=29). Hemaglobin A1c (HbA1c) was assessed at 3 and 6 months following re-randomization.

Results: Marked HbA1c improvements observed in DiaTel ACM participants were sustained 6 months after re-randomization in both ACM-to-CCHT and ACM-to-CC groups. Lesser HbA1c improvements observed in DiaTel CC participants were sustained in both CC-to-CC and CC-to-UC groups. No benefit was apparent for continued transmission of glucose data among DiaTel ACM participants or continued monthly telephone calls among DiaTel CC participants 6 months after re-randomization.

Conclusion: Significant improvements in HbA1c achieved using home telemonitoring and active medication management for 6 months were sustained 6 months later with interventions of decreased intensity in VA Health System-qualified veterans. CLINICAL TRIAL REG. NO: NCT00245882, http://www.clinicaltrials.gov.

Figure 1

Design of the DiaTel Study and the DiaTel Extension. ACM, active care management; VAPHS, VA Pittsburgh Healthcare System.

Figure 2

Pairwise comparisons of hemoglobin A1c (HbA1c) at 6, 9, and 12 months to test each hypothesis. The 6-month measurement is from DiaTel; the 9 and 12 months measurements are taken during the DiaTel Extension. In each plot, a solid dot denotes the data points and a solid line connects the time-specific means for the ‘more intensive’ intervention, and a hollow circle denotes the data points and a dotted line connects the time-specific means for the ‘less intensive’ intervention. The ‘more intensive’ intervention is ACM-to-CCHT in (a), ACM-to-CC in (b), and CC-to-CC in (c). The corresponding ‘less intensive’ intervention is ACM-to-CC in (a), CC-to-CC in (b), and CC-to-UC in (c). (a) ACM-to-CCHT versus ACM-to-CC (continued data transmission), (b) ACM-to-CC versus CC-to-CC (initial active care management) (c) CC-to-CC versus CC-to-UC (continued monthly calls). ACM, active care management; CC, care coordination; CCHT, care coordination with continued home telemonitoring; UC, usual care.

Figure 3

Profile plot of mean hemoglobin A1c (HbA1c) over time by DiaTel Extension intervention group. Participants were re-assigned randomly at 6 months, so the measurements at 0, 3 and 6 months reflect the initial DiaTel intervention for these DiaTel Extension participants.