The Diabetes Telemonitoring (DiaTel) Study
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this research study is to compare two different methods of helping veterans
      with diabetes better manage their disease. This study will compare an "Active Care
      Management" method using home-based technology and self-monitoring techniques with a
      lower-intensity "Care Coordination" method based on monthly telephone contact with a nurse.
    

Detailed description: 
      The objectives of this study are to design, implement, and evaluate two medical care
      initiatives of different levels of intensity for veterans with diabetes and suboptimal
      glycemic control. The higher-intensity initiative ("Active Care Management") will use
      home-based technology that enables home messaging and reminders for compliance with
      recommended guidelines for treatment, as well as self-monitoring of blood glucose, blood
      pressure, and weight. Data will be transmitted to health care providers. This initiative will
      feature active care management, including changes in medication and/or diet implemented by
      the study's certified registered nurse practitioner under the supervision of a study
      physician in collaboration with the subject's primary care provider (PCP).

      The lower-intensity initiative ("Care Coordination") will consist of care coordination in the
      form of monthly monitoring of subjects via telephone by the study's research nurse who will
      refer the subject to his/her PCP as needed for additional care. Both initiatives represent a
      supplementation to current usual care practices for the treatment of diabetes in the VA.

      The objective of Phase Two of the study is to determine the appropriate level of subsequent
      management required for sustaining glycemic, blood pressure (BP), and lipid control among
      subjects randomized in Phase One to care coordination (CC) or to active care management
      (ACM). CC involved monthly telephone calls from a diabetes nurse (RN), whereas ACM involved
      home messaging and monitoring with the Viterion TeleHealth System plus active management of
      glycemia, BP, and lipids by a nurse practitioner (NP). ACM subjects transmitted blood
      glucose, BP, and weight measurements daily for review and intervention, if necessary, by the
      NP.

      Subjects who complete Phase One and consent to participate in Phase Two will be randomized to
      subsequent management at the same or lower intensity and followed for an additional six
      months. Phase One ACM subjects will be randomized in Phase Two to either care coordination
      with monthly telephone calls (i.e., ACM-to-CC), or care coordination with monthly telephone
      calls plus home telehealth monitoring but with no active management by the NP (ACM-to-CCHT).
      CCHT subjects will continue to transmit home blood glucose, BP, and weight daily to the
      project office, but abnormal values will be referred to their primary care provider (PCP) for
      action. Phase One CC subjects will be randomized to either continued care coordination with
      monthly telephone calls (CC-to-CC), or referral back to their PCP for usual care (CC-to-UC).
      Randomization within both groups for Phase Two will be stratified according to HbA1c (<7% or
      >7%) at the conclusion of the subject's six-month participation in Phase One.

      The primary aim of Phase Two is to assess whether glycemic, blood pressure, and lipid control
      at the end of an additional six months of follow-up differs for patients randomized to the
      four groups specified above (i.e., ACM-to-CC, ACM-to-CCHT, CC-to-CC, and CC-to-UC), adjusted
      for their corresponding HbA1c levels at the end of Phase One.
    

Intervention name(s): Care Coordination; Home Telemedicine
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Care coordination with monthly follow-up by a diabetes nurse educator; Active care management by a nurse practitioner using home telemedicine
Other intervention name(s): Control; Active Care Management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telehealth; Veterans; Glycemic control; Active care management; Care coordination