Effect of Mobile Phone Telemedicine on Diabetes Care

Diabetes Mellitus Clinical Trial

Official title:

Effect of Mobile Phone Telemedicine on Diabetes Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698008
• Other study ID #: 0396-12-FB
• Status: Completed
• Phase: N/A
• Start date: January 28, 2012
• Est. completion date: September 25, 2013

Study information

• Verified date: October 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adult patients with diabetes on insulin are eligible for the study. They will be randomized to a group using standard of care communication and a group using an I phone intervention.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 25, 2013
• Est. primary completion date: September 25, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence for Improved Diabetic Care With Mobile Phone Application Use	Satisfaction and usability was evaluated with a survey for those subjects who used the mobile phone application at the 3 and 6 months period.	Six months