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

NCT01075997 | Unknown

• 1 other identifier: WU#07-13025
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be improvement of glycemic control as measured by glycosylated hemoglobin (A1c).

  week 0, week 12, week 26, week 38, week 52

Secondary Outcomes (1)

• 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.

  week 0, week 12, week 26, week 38, week 52

Study Arms (2)

A cell phone tips

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.

Device: cell phone delivered tele-educational

B no cell phone tips

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.

Device: cell phone

Interventions

cell phone delivered tele-educational 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.

Also known as: A cell phone tips

A cell phone tips

cell phone 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.

Also known as: B no cell phone tips

B no cell phone tips

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead
• Affinity Networks, Inc.: collaborator

Study Sites (1)

Walter Reed Army Hospital Center

Washington D.C., District of Columbia, 20307, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Amanda Bell, MD

  WRAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: November 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 25, 2010

Record last verified: 2009-06

Locations

US (1)