Effect of Mobile Phone Telemedicine on Diabetes Care
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01698008|
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : August 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Device: Diabetes Doctor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|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 use
The intervention group will be instructed to submit their blood glucose logs once a month with the use of a mobile application, Diabetes Doctor, to the provider who will make insulin regimen changes. All subjects will be evaluated once at initial, 3 month, and 6 month visits. They will receive HbA1c on each visit. After the initial 3 months have been completed a 15 question Diabetes Quality of Life survey will be completed by all patients from both groups. A Usability and Satisfaction of Diabetes Doctor survey will be given to those patients who used the mobile application. At the 3 month interval the control group will be given the opportunity to use the mobile application if desired. The study group will be given the opportunity to continue or discontinue the use of the mobile application. At the 6 month interval the Usability and Satisfaction of Diabetic Doctor survey and 15 question Diabetes Quality of Life survey will be administered to evaluate all mobile application users.
Device: Diabetes Doctor
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.
- Evidence for improved diabetic care with mobile phone application use [ Time Frame: Six months ]Satisfaction and usability will be evaluated with a survey for those subjects who used the mobile phone application at the 3 and 6 months period. The contents of the satisfaction and usability survey include questions addressing the degree of the subjects understanding of operating the mobile application and their ability to comprehend the providers insulin adjustment recommendations. Other questions in the survey assess the degree of the subjects agreement to the insulin adjustment recommendations, how efficiently the subject received a response from their provider, adherence to the mobile application, their assessment of the mobile applications usefulness, their attention given to diabetes and to the mobile application recommendations.
- Improved quality of life [ Time Frame: Six months ]Quality of life will be measured by comparing the control group with the intervention group using a validated 15 question Diabetes Quality of Life survey at the three and six month interval of the study.
- Improved blood glucose control [ Time Frame: Six months ]Parameters of improved blood glucose control to be assessed will be defined by improved HbA1c, less frequent hypoglycemic events, and decreased blood glucose dispersion.
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|