Effect of Mobile Phone Telemedicine on Diabetes Care

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Jay Patel, MD, University of Nebraska Medical Center
ClinicalTrials.gov Identifier:
NCT01698008
First received: September 28, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

Type 1 or type 2 diabetes mellitus subjects who know how to operate and own an iPhone, are between the age of 19 to 75, and are on a basal/bolus insulin regimen will be included in the study. Subjects will be randomized to two groups - iPhone versus standard of care and seen in our clinic at an initial/baseline and three month clinical visit. The control group will e-mail, fax, or call their blood glucose log results once a month for an insulin regimen adjustment through verbal communication with a certified diabetic educator once a month as is already implemented at the Diabetes Center. This group will be compared to the intervention group who will submit their blood glucose log results through an iPhone mobile application, called Diabetes Doctor, once a month for an insulin regimen adjustment by a physician with a text message response. The two groups will have their HbA1c, hypoglycemic events, blood glucose dispersion compliance, quality of life, usability and satisfaction with the use of a mobile application will be assessed at each visit with surveys.


Condition Intervention
Diabetes Mellitus
Device: Diabetes Doctor

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of Mobile Phone Telemedicine on Diabetes Care

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Evidence for improved diabetic care with mobile phone application use [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Improved quality of life [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Improved blood glucose control [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Parameters of improved blood glucose control to be assessed will be defined by improved HbA1c, less frequent hypoglycemic events, and decreased blood glucose dispersion.


Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 1 or type 2 Diabetes Mellitus on insulin basal/bolus injection
  • Own and are able to operate an iPhone

Exclusion Criteria:

  • Type 2 diabetics using only oral medications
  • Do not own or know how to operate an iPhone
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698008

Contacts
Contact: Jay Patel, M.D. 402-559-9013

Locations
United States, Nebraska
The University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68198
Contact: Jay R. Patel, M.B.B.S.    402-559-9013    jay.patel@unmc.edu   
Sub-Investigator: Jay R. Patel, M.B.B.S.         
Sponsors and Collaborators
Jay Patel, MD
Investigators
Principal Investigator: Whitney S Goldner, M.D. University of Nebraska
  More Information

No publications provided

Responsible Party: Jay Patel, MD, House Officer, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT01698008     History of Changes
Other Study ID Numbers: 396-12-FB
Study First Received: September 28, 2012
Last Updated: September 28, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 26, 2014