Enhancing self-management of T2DM with an Automated Reminder and Feedback System (Wisconsin)

Project Final Report (PDF, 468.64 KB) Disclaimer

Project Details - Ended

Project Categories

Summary:

Type 2 diabetes mellitus (T2DM) occurs in 9 percent of adult Americans and is more prevalent among ethnic minorities. Tight control of blood sugars is critical in reducing complications of diabetes. Exercise and a healthy diet can lead to better control than medication and are important components in diabetes management. Yet many diabetics do not eat properly or exercise regularly, which leads to suboptimal control. Because optimum control requires significant self-management, this project sought to develop an automated self-management monitor (ASMM) and test its impact of on glycemic control and self-management behaviors. The ASMM was composed of a simple personal computer-glucometer interface, a docking unit, and specialized software. The device reminded patients to self-monitor their blood glucose, prompted them to take their medications, and provided education on the importance of lifestyle choices.

The specific aims of the study were to:

  • Demonstrate that use of the ASMM improves glycemic control in people with T2DM.
  • Demonstrate that this effect is sustained over longer-term followup.
  • Identify self-management practices that improve control in people using the ASMM.

Participants with poorly controlled T2DM were recruited from the Veterans Health Administration and community-based primary care clinics. Individuals were randomized to either the intervention or the usual care group. Study visits took place at baseline, 3, 9, and 15 months. The final analysis showed that 43 percent of the intervention group who completed the trial used the system regularly and had a significant reduction in hemoglobin A1c compared to infrequent users. Regular system users trended toward being older, had longer duration of disease, were more likely to be on insulin, and spent fewer hours in sedentary behavior.

Enhancing self-management of T2DM with an Automated Reminder and Feedback System - 2011

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS07-007: Ambulatory Safety and Quality Program: Enabling Patient-Centered Care Through Health Information Technology (PCC)
  • Grant Number: 
    R18 HS 017276
  • Project Period: 
    September 2007 - August 2011
  • AHRQ Funding Amount: 
    $1,166,243
  • PDF Version: 
    (PDF, 192.31 KB)

Summary: This project tested the impact of an automated self-management monitor (ASMM) on glycemic control and self-management behaviors. The ASMM reminded patients to self-monitor their blood glucose (SMBG), prompted them to take medications, and provided education on the impact of lifestyle choices. The research team developed the ASMM, which is composed of a simple personal computer-glucometer interface, a docking unit, and specialized software. When the ASMM is docked, the software received data downloaded through the glucometer interface, interpreted the measures, matched them with individualized profiles for glycemic monitoring and control, and provided appropriate, individualized audio feedback. Feedback was based on a fuzzy logic algorithm that took into account current and previous values. Feedback also incorporated the Common Sense Model of Illness, a model that accounts for patients' perceptions of illness, including their comprehension of symptoms and coping mechanisms. The ASMM provided information on long-term control, as well as single glucose measures.

To demonstrate the effectiveness of the intervention, the project team recruited adults from community health centers and the Veteran's Health Administration (VHA) to participate in a randomized controlled trial. To participate subjects needed to have poorly controlled diabetes, defined as hemoglobin A1c (HbA1c) levels greater than 8 percent. Once participants were recruited, the project team contacted providers to obtain information about patients' glucose checking schedules and glycemic targets. A team member visited participants at home to collect baseline data and provide the glucometer and supplies necessary to perform SMBG. Three months later, at a second home visit, a study team member provided the participant with a standard set of educational materials, administered study surveys, determined any self-reported change in the medication regimen, and downloaded glucometer data. The patient was then randomized into either the intervention or usual care group. Intervention group participants received the ASMM and training on how to use the system. Additional home visits were conducted 9- and 15-months after enrollment. The primary outcome measure was a change in HbA1c levels. Secondary measures included self-management behaviors such as SMBG frequency, nutritional choices, physical activity, medication adherence, and patient use of diabetes educational materials.

Specific Aims:

  • Demonstrate that use of the ASMM improves glycemic control in inadequately-controlled people with Type 2 diabetes. (Achieved)
  • Demonstrate that this effect is sustained over longer-term followup. (Achieved)
  • Identify self-management practices that improve in people using the ASMM. (Achieved)

2011 Activities: The randomized trial was completed in October 2010. In 2011, significant effort was dedicated to data cleaning, coding, and analysis. Statisticians reviewed the data files to merge and reconcile data recorded by the glucometers and data collected by the ASMM docking system. The analysis sought to identify differences in HBA1c levels over time and across intervention and usual care groups. Additionally, statisticians analyzed the differences between the data collected from the VHA and community-based care. The study team determined which patients engaged the intervention and identified differences in patterns of ASMM use. Additional analyses of behavior factors included cognitive function, age, income, health literacy, and beliefs about diabetes.

This project used a 1-year no-cost extension to complete the project. As last self-reported in the AHRQ Research Reporting System, project progress and activities were completely on track according to the revised timeline, and project budget spending was on target. This project was completed in August 2011.

Preliminary Impact and Findings: A total of 201 participants were randomized, with 102 individuals in the intervention group and 99 in the usual care group. Of these, 71 intervention participants and 89 usual care participants completed the 15-month study with analyzable ASMM data. The primary outcome analysis, change in HbA1c levels, demonstrated a significant decrease in HbA1c for all participants from baseline to 15 months (p<.0001). Overall, however, there was no significant difference in HbA1c between the intervention and usual care groups, or for VHA versus community participants. Descriptive analyses of medication changes over time show that community participants were more likely to remain on the same medicines and doses throughout the study than veteran participants (62.3 versus 52.1 percent); and less likely to have their insulin dose increased (18.9 versus 30.1 percent). Dr. Burns hypothesizes that the use of the VHA electronic medical record, which has built-in flags and reminders for diabetes management, led to more ongoing medication management resulting in fewer medication adjustments.

The following three patterns of ASMM use were evident in the intervention group: approximately 20 percent of participants appeared to not use the system at all, or requested that it be removed; 37 percent interacted with the system either on a short-term basis (1 to 2 months), or sporadically over the entire period (less than once every 2 weeks). The remaining 43 percent used the system on a regular basis. ASMM usage and docking patterns indicated that closer monitoring, or more frequent use of the ASMM, was associated with improved glucose control. Each additional docking of the ASMM within a 2-day period was associated with a decrease in glucose level of 1.4 mg/dl (p<0.0001). This group of frequent users had an average drop of 0.5 points in HbA1c compared to 0.06 for the infrequent users (p<0.05). Those regularly using the system during the final phase of the study (months 9 to 15), had an average decrease of 0.63 points in HbA1c versus 0.12 for infrequent users (p<0.008). Patients who did not regularly dock the ASMM did not receive feedback from the system. The finding suggests that monitoring may result in improved control over time.

Demographic and behavioral factors that may have accounted for the decrease in HbA1c in all groups were also analyzed. Frequent system users trended toward being older (62 versus 59 years, p=0.06), had longer duration of disease (15.5 versus 11.2 years, p<0.003), and were more likely to be on insulin. At baseline they also had a greater fear of hypoglycemia, and scored higher on worry items related to diabetes self-management. Additionally, frequent users spent fewer hours in sedentary behavior at 15 months (3.8 versus 5.4 hours/day, p<0.008). Dr. Burns hypothesizes that more-frequent users responded to the feedback by making adjustments to their self-management behaviors, but the standard measures used may not have had enough sensitivity to detect significant changes in this relatively small group of individuals. The findings suggest the need to consider patient perceptions of illness when designing such interventions in order to achieve greater overall efficacy.

Target Population: Chronic Care*, Diabetes, Elderly*, Medically Underserved, Veterans

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to support patient-centered care, the coordination of care across transitions, and the electronic exchange of health information to improve quality of care.

Business Goal: Implementation and Use

* This target population is one of AHRQ's priority populations.

Enhancing self-management of T2DM with an Automated Reminder and Feedback System - 2010

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS07-007: Ambulatory Safety and Quality Program: Enabling Patient-Centered Care Through Health Information Technology (PCC)
  • Grant Number: 
    R18 HS 017276
  • Project Period: 
    September 2007 – August 2011, Including No-Cost Extension
  • AHRQ Funding Amount: 
    $1,166,243
  • PDF Version: 
    (PDF, 307.96 KB)


Target Population: Chronic Care*, Diabetes, Elderly*, Medically Underserved, Veterans

Summary: This project tests whether an automated self-management monitor (ASMM) that reminds patients to self-monitor their blood glucose (SMBG), prompts them to take medications, and provides education on the impact lifestyle choices has on glycemic control and self-management behaviors. The ASMM, which was developed by the project team, is composed of a simple personal computer-glucometer interface unit with specialized software. The software receives data downloaded through the glucometer interface; interprets the measures; matches them with individualized profiles for glycemic monitoring and control; and provides appropriate, individualized audio feedback. Feedback is based on a fuzzy logic algorithm, which is feedback on one value while taking into account previous values, as well as the Common Sense Model of Illness, or experience-based beliefs. These provide information on long-term control, as well as single glucose measures.

To demonstrate the effectiveness of the intervention, the project team is recruiting adults from community health centers and the Veteran’s Health Administration to participate in a randomized, controlled trial. To be eligible for participation, subjects must have poorly controlled diabetes, defined as hemoglobin A1c (HbA1c) levels greater than 8 percent. Once participants are recruited, the project team contacts providers to obtain information about patients’ glucose checking schedules and glycemic targets. A team member visits a participant’s home to collect baseline data, and provide the glucometer and supplies necessary to perform SMBG. At a second home visit 3 months later, a member of the team provides the participant with a standard set of educational materials, administers study surveys, determines any self-reported change in medication regimen, and downloads glucometer data. Patients are then randomized into intervention and usual care groups. For intervention group participants, the researcher also installs the ASMM, trains the participants to use the system, and reviews the reminders provided by the system. Additional home visits are conducted by the research team at 9 and 15 months after enrollment. The primary outcome measure is change in HbA1c. Secondary measures include self-management behaviors such as SMBG frequency, nutritional choices, physical activity, medication adherence, and patient use of diabetes educational materials.

Specific Aims:
  • Demonstrate that use of the ASMM improves glycemic control in inadequately-controlled people with Type 2 Diabetes. (Ongoing)
  • Demonstrate that this effect is sustained over longer term followup. (Ongoing)
  • Identify self-management practices that improve in people using the ASMM. (Ongoing)

2010 Activities: The trial was completed in October 2010. A total of 201 participants were randomized, with 102 individuals in the intervention group and 99 in the usual care group. Of these, 71 intervention participants and 89 usual care participants completed the 15-month study with analyzable ASMM data.

During the year, significant effort was dedicated to data cleaning, coding, and analysis. Statisticians reviewed the data files to merge and reconcile data recorded by the glucometers and data collected by the ASMM docking system. Additionally, statisticians started to look at differences between the data collected from the Veteran’s Health Administration and community-based care, including differences in loss-to-followup between the two study arms.

The study team is also trying to determine which patients engaged the intervention. While some patients decided that they did not want to keep the ASMM system, other patients kept the system but did not use it. Therefore the analysis team will perform an intent-to-treat analysis as well as a second analysis of patients who actively engaged with the intervention to determine whether those who actually received feedback from the ASMM demonstrated improved glycemic control. The team will also assess characteristics of individuals who used the intervention to help inform clinicians about patients who are most likely to benefit from this approach to diabetes care.

Grantee’s Most Recent Self-Reported Quarterly Status (as of December 2010): All aims and milestones are on track and data collection is in process. The trial has been completed and data have been collected and cleaned. Analyses to evaluate the intervention will be the focus of the next year

Preliminary Impact and Findings: Randomization was successful, with no significant differences in demographic variables or baseline HbA1c levels between the usual care and intervention groups. Efforts to distinguish between intervention group participants who used the ASMM and those who did not indicate that seven participants refused at the installation stage but stayed in the study, three had the system installed but never used it, three were unable to use the system for other reasons, and 18 dropped out of the study.

Preliminary analyses of dietary data show no significant relationships between broad dietary components (total carbohydrates, total calories, total protein, total fiber, calories from fat) and HbA1c. However, participants with initial HbA1c levels lower than 14 appear to have lower total carbohydrates, total fiber, and fat-derived calories than those with baseline HbA1c greater than 14. Analyses of patient characteristics and glycemic control identified a statistically significant correlation between commonsense beliefs about diabetes and glycemic control.

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to support patient-centered care, the coordination of care across transitions, and the electronic exchange of health information to improve quality of care.

Business Goal: Implementation and Use

*AHRQ Priority Population.

Enhancing self-management of T2DM with an Automated Reminder and Feedback System - Final Report

Citation:
Burns E. Enhancing self-management of T2DM with an Automated Reminder and Feedback System - Final Report. (Prepared by Medical College of Wisconsin under Grant No. R18 HS017276). Rockville, MD: Agency for Healthcare Research and Quality, 2012. (PDF, 468.64 KB)

The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
Principal Investigator: 
Document Type: 
Medical Condition: 

ASSM Algorithm Script Version 2 based on Draft Algorithm 8 January 30, 2008

PDF: ASSM Algorithm Script Version 2 based on Draft Algorithm 8 January 30, 2008 (PDF, 44.8 KB)
This project does not have any related survey.
This project does not have any related project spotlight.
This project does not have any related survey.
This project does not have any related story.
This project does not have any related emerging lesson.