A Novel Telemonitoring Device for Improving Diabetes Control: Protocol and Results from a Randomized Clinical Trial
Alice R. Pressman, PhD, MS,1,2 Linda Kinoshita, MA,3 Susan Kirk, RN, CCRC,3 Gina Monraz Barbosa, RN, MSN/MBA,3 Cathy Chou, MPA,1 and Jerome Minkoff, MD3 1
Kaiser Permanente Division of Research, Oakland, California. Sutter Health Research, Development, and Dissemination, Walnut Creek, California. 3 Kaiser Permanente, Santa Rosa, California. 2
Abstract Background: Telemedicine is one approach to managing patients with chronic illness. Several telephone-based monitoring studies of diabetes patients have shown improved glycosylated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL) levels. The purpose of this study was to evaluate an investigational in-home telemetry device for improving glucose and BP control over 6 months for patients with type 2 diabetes. The device was used to transmit weekly blood glucose, weight, and BP readings to a diabetes care manager. Subjects and Methods: We conducted a twoarm, parallel-comparison, single-blind, randomized controlled trial among Kaiser Permanente Northern California members 18–75 years old with type 2 diabetes mellitus and entry HbA1c levels between 7.5% and 10.0%. Participants were randomly assigned to either the telemonitoring arm or the usual care arm. Results: We observed very small, nonsignificant changes in fructosamine (telemonitoring, -54.9 lmol; usual care, -59.4 lmol) and systolic BP (telemonitoring, -6.3 mm Hg; usual care, -3.2 mm Hg) from baseline to 6 weeks in both groups. At 6 months, we observed no significant intergroup differences in change from baseline for HbA1c, fructosamine, or self-efficacy. However, LDL cholesterol in the telemonitoring arm decreased more than in the usual care arm ( -17.1 mg/dL versus -5.4 mg/dL; P = 0.045). Conclusions: Although HbA1c improved significantly over 6 months in both groups, the difference in improvement between the groups was not significant. This lack of significance may be due to the relatively healthy status of the volunteers in our study and to the high level of care provided by the care managers in the Santa Rosa, CA clinic. Further study in subgroups of less healthy diabetes patients is recommended. Key words: diabetes care telemonitoring device trial
DOI: 10.1089/tmj.2013.0157
Introduction
W
ith the incidence of type 2 diabetes mellitus (DM) on the rise, the burden of disease is similarly increasing. Morbidity and mortality for patients with DM remain high despite the availability and use of various antidiabetic therapies, and the impact on medical costs has increased over the past several decades.1 In 2007, expenditures for DM were more than $174 billion in the United States,2 and as our population ages, the prevalence of DM is expected to increase, along with the associated disease burden. Careful glucose control is advocated by most experts in the DMmanagement field.3 Microvascular complications appear to be less prevalent with improved glycemic control,4–7 although it is controversial whether macrovascular-related conditions in type 2 DM are reduced with tighter glucose control.8–10 More aggressive control of other cardiovascular risk factors is also generally advocated for patients with DM, including blood pressure (BP) control to 130 mm Hg systolic and
Alice R. Pressman, PhD, MS,1,2 Linda Kinoshita, MA,3 Susan Kirk, RN, CCRC,3 Gina Monraz Barbosa, RN, MSN/MBA,3 Cathy Chou, MPA,1 and Jerome Minkoff, MD3 1
Kaiser Permanente Division of Research, Oakland, California. Sutter Health Research, Development, and Dissemination, Walnut Creek, California. 3 Kaiser Permanente, Santa Rosa, California. 2
Abstract Background: Telemedicine is one approach to managing patients with chronic illness. Several telephone-based monitoring studies of diabetes patients have shown improved glycosylated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL) levels. The purpose of this study was to evaluate an investigational in-home telemetry device for improving glucose and BP control over 6 months for patients with type 2 diabetes. The device was used to transmit weekly blood glucose, weight, and BP readings to a diabetes care manager. Subjects and Methods: We conducted a twoarm, parallel-comparison, single-blind, randomized controlled trial among Kaiser Permanente Northern California members 18–75 years old with type 2 diabetes mellitus and entry HbA1c levels between 7.5% and 10.0%. Participants were randomly assigned to either the telemonitoring arm or the usual care arm. Results: We observed very small, nonsignificant changes in fructosamine (telemonitoring, -54.9 lmol; usual care, -59.4 lmol) and systolic BP (telemonitoring, -6.3 mm Hg; usual care, -3.2 mm Hg) from baseline to 6 weeks in both groups. At 6 months, we observed no significant intergroup differences in change from baseline for HbA1c, fructosamine, or self-efficacy. However, LDL cholesterol in the telemonitoring arm decreased more than in the usual care arm ( -17.1 mg/dL versus -5.4 mg/dL; P = 0.045). Conclusions: Although HbA1c improved significantly over 6 months in both groups, the difference in improvement between the groups was not significant. This lack of significance may be due to the relatively healthy status of the volunteers in our study and to the high level of care provided by the care managers in the Santa Rosa, CA clinic. Further study in subgroups of less healthy diabetes patients is recommended. Key words: diabetes care telemonitoring device trial
DOI: 10.1089/tmj.2013.0157
Introduction
W
ith the incidence of type 2 diabetes mellitus (DM) on the rise, the burden of disease is similarly increasing. Morbidity and mortality for patients with DM remain high despite the availability and use of various antidiabetic therapies, and the impact on medical costs has increased over the past several decades.1 In 2007, expenditures for DM were more than $174 billion in the United States,2 and as our population ages, the prevalence of DM is expected to increase, along with the associated disease burden. Careful glucose control is advocated by most experts in the DMmanagement field.3 Microvascular complications appear to be less prevalent with improved glycemic control,4–7 although it is controversial whether macrovascular-related conditions in type 2 DM are reduced with tighter glucose control.8–10 More aggressive control of other cardiovascular risk factors is also generally advocated for patients with DM, including blood pressure (BP) control to 130 mm Hg systolic and
