Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatments cell phone delivered tele-educational, cell phone
Sponsor Walter Reed Army Medical Center
Collaborator Affinity Networks, Inc.
Start date November 2007
End date July 2010
Trial size 170 participants
Trial identifier NCT01075997, WU#07-13025

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
cell phone delivered tele-educational 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.
(Active Comparator)
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.
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 your provider. The groups will have blood sugars downloaded from from the glucometer by your provider at every visit and reviewed.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 89 years old.

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

Additional Information

Official title The Impact of a Video Cell Phone Reminder System on Glycemic Control in Patients With Diabetes Mellitus
Principal investigator Amanda Bell, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Walter Reed Army Medical Center.