MedDataX Logo

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

NCT ID: NCT01075997

Last Updated: 2010-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

cell phone delivered tele-educational

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

cell phone

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

A cell phone tips B no cell phone tips

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Affinity Networks, Inc.

INDUSTRY

Sponsor Role collaborator

Walter Reed Army Medical Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Walter Reed Army Medical Center,

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amanda Bell, MD

Role: PRINCIPAL_INVESTIGATOR

WRAMC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Walter Reed Army Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WU#07-13025

Identifier Type: -

Identifier Source: org_study_id