Effect of Mobile Phone Telemedicine on Diabetes Care
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|ClinicalTrials.gov Identifier: NCT01698008|
Recruitment Status : Completed
First Posted : October 2, 2012
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Other: Diabetes Doctor Mobile app||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||One group is standard of care. The other is given the opportunity to use a new mobile app for reporting blood sugars.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Mobile Phone Telemedicine on Diabetes Care|
|Actual Study Start Date :||December 2012|
|Actual Primary Completion Date :||September 25, 2013|
|Actual Study Completion Date :||September 25, 2013|
Experimental: Mobile application Diabetes Doctor
The intervention group will send in blood glucoses once a month using the mobile phone app, Diabetes Doctor. All subjects will be evaluated at initial, 3 month, and 6 month visits. They will receive HbA1c on each visit. After 3 months, a Diabetes Quality of Life (QOL) survey will be completed. A Usability and Satisfaction of Diabetes Doctor (USDD) survey will also be obtained. At the 3 month visit, they will also be given the chance to discontinue the mobile app and switch to standard of care. At 6 months, all mobile app users will complete the USDD and satisfaction and QOL survey. If they are not using the mobile app, then they will complete the QOL survey.
Other: Diabetes Doctor Mobile app
Diabetes Doctor is a mobile application software. The mobile phone application allows a subject to register blood glucose values obtained from their fingerstick glucose meter readings, the type and amount of insulin they are administering, any notes they would like to document, and the date and time of each entry. All data will be entered by the subject manually. The data will be submitted through encryption coded private servers and can be retrievable by a physician on a password protected website for privacy. A physician will evaluate this information to recommend a change of the subject's insulin regimen. The recommended insulin regimen will be delivered to the patient using the same website and received by the subject on the same mobile application software.
No Intervention: Standard of Care
The standard of care arm will not use the mobile application Diabetes Doctor to communicate with their physician about their blood sugars. They will attend clinic visits and have evaluations initially, and at 3 and 6 months. They will also receive a HbAIc at each visit. They will do the same QOL survey at 3 months. At 6 months, they will be given the QOL survey.
- Evidence for Improved Diabetic Care With Mobile Phone Application Use [ Time Frame: Six months ]Satisfaction and usability was evaluated with a survey for those subjects who used the mobile phone application at the 3 and 6 months period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698008
|United States, Nebraska|
|The University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Whitney S Goldner, M.D.||University of Nebraska|