The Impact of a Video Cell Phone Reminder System on Glycemic Control in Patients With Diabetes Mellitus

February 24, 2010 updated by: Walter Reed Army Medical Center
The purpose of the study is to determine whether having a video cell phone that gives daily reminders over a 6-month period to check blood surgery and take your diabetes medications can improve your diabetes control during that time and if that benefit lasts for up to 1 year.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine if a cell phone video reminder system will improve compliance and glycemic control in patients with diabetes mellitus when compared with standard of care. We plan to partner with Affinity Network, Inc., a local minority-owned small business, to provide broadband-enabled cell phone service to patients with diabetes mellitus. Their IntelaCare™ system will host the content and transmit it to the phones on a personalized schedule. This will be a prospective, randomized, controlled trial comparing patients with diabetes mellitus who receive daily video reminders via cell phone to take their medications and check their blood glucose with patients who are just given a cell phone without daily reminders. The primary endpoint will be improvement of glycemic control as measured by glycosylated hemoglobin (A1c). The secondary endpoints will compare mean daily glucose levels, the number of both hypoglycemic and hyperglycemic events, the amount of time spent in target blood glucose, and the perceived level of diabetes-related stress between the two groups. Patients in both groups will receive a broad-band enabled cell phone and cell phone service for the duration of the study. Patients will be randomized into a "cell phone" group (group A) and a "cell phone plus reminder" group (group B). They will be seen by their provider at least quarterly (or more often as clinically appropriate). Blood glucose readings will be downloaded from patients' glucometers at every provider visit (at least quarterly). Group B will receive a daily 15-second video from their provider reminding them to take their medication and to test their blood sugar and an educational "tip-of-the day." These reminders will be personalized and recorded by their provider. During the second 6 months, the patients will be followed by their provider at least quarterly. Improvement in glycemic control will be determined by quarterly measurements of A1c and the mean and standard deviation of blood glucose. In addition, the number of home blood glucose tests performed on a weekly basis will be compared. Compliance with medication will be determined by pharmacy refill records and pill counts. Quality-of-life will be measures using 2 validated instruments at 0, 26 and 52 weeks - the Problem Areas in Diabetes (PAID), which is a diabetes-related quality of life questionnaire and the SF-8, which is a general quality of life questionnaire for people with chronic disease.

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington DC, District of Columbia, United States, 20307
        • Walter Reed Army Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18 or greater
  • A1c greater than 8%
  • ability to use a cell phone and glucose meter
  • ability to understand English
  • on oral therapy and/or insulin

Exclusion Criteria:

  • under age 18
  • non-English speaking
  • females who are pregnant, lactating, planning to become pregnant, or without a safe contraceptive method
  • A1c less than 8%
  • use of glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A cell phone tips
This group will receive a cell phone and cell phone service for 1 year. This group will receive a daily video reminders and tips for the first 6 months of the study. For the second 6 months this group will be seen by their providers at least every 3 months, but the video reminders and and tips will no longer be sent. The group will be instructed on how to use the cell phone. The group will be asked to check blood sugar on a schedule determined by their providers. The group will have blood sugars downloaded from from the glucometer by their providers at every visit and reviewed. The group will have the A1c measured. Also it will have this test repeated about every 3 months. They will continue to have monitored their A1c at 24, 38 and 52 weeks of the study.
Device: cell phone delivered tele-educational
This group will receive a cell phone and cell phone service for 1 year. This group will receive a daily video reminders and tips for the first 6 months of the study. For the second 6 months this group will be seen by their providers at least every 3 months, but the video reminders and and tips will no longer be sent. The group will be instructed on how to use the cell phone.
Other Names:
  • A cell phone tips
Active Comparator: B no cell phone tips
This group will receive a cell phone and cell phone service for 1 year. For the second 6 months this group will be seen by their providers at least every 3 months. The group will be instructed on how to use the cell phone.The group will be asked to check blood sugar on a schedule determined by their provider. The groups will have blood sugars downloaded from from the glucometer by their provider at every visit and reviewed. The group will have A1c measured. Also it will have this test repeated about every 3 months. They will continue to have monitored their A1c at 24, 38 and 52 weeks of the study.
Device: cell phone
This group will receive a cell phone and cell phone service for 1 year. For the second 6 months this group will be seen by their providers at least every 3 months. The group will be instructed on how to use the cell phone.The group will be asked to check blood sugar on a schedule determined by your provider. The groups will have blood sugars downloaded from from the glucometer by your provider at every visit and reviewed.
Other Names:
  • B no cell phone tips

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint will be improvement of glycemic control as measured by glycosylated hemoglobin (A1c).
Time Frame: week 0, week 12, week 26, week 38, week 52
week 0, week 12, week 26, week 38, week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare mean blood glucose levels,the number of hypo- and hyperglycemic events,the duration of time spent in target blood glucose range,the perceived level of diabetes-related stress and the perceived effect of diabetes on quality of life.
Time Frame: week 0, week 12, week 26, week 38, week 52
week 0, week 12, week 26, week 38, week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Reed Army Medical Center

Collaborators

Affinity Networks, Inc.

Investigators

  • Principal Investigator: Amanda Bell, MD, WRAMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Anticipated)

July 1, 2010

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

February 24, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (Estimate)

February 25, 2010

Study Record Updates

Last Update Posted (Estimate)

February 25, 2010

Last Update Submitted That Met QC Criteria

February 24, 2010

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WU#07-13025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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