Effect of Mobile Phone Telemedicine on Diabetes Care

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: Diabetes Doctor Mobile app

• Registration Number: NCT01698008
• Lead Sponsor: University of Nebraska

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-01-28
• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-02
• Primary Completion: 2013-09-25
• Study Completion: 2013-09-25
• Results First Submitted: 2018-01-29
• Results First Submitted QC: 2018-03-05
• Results First Posted: 2018-11-02
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile application Diabetes Doctor	Diabetes Doctor Mobile app	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.

Primary Outcome Measures

Name	Time	Method
Evidence for Improved Diabetic Care With Mobile Phone Application Use	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.

Trial Locations

Locations (1)

The University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States