Trial Outcomes & Findings for Effect of Mobile Phone Telemedicine on Diabetes Care (NCT NCT01698008)

NCT ID: NCT01698008

Last Updated: 2023-10-17

Results Overview

Satisfaction and usability was evaluated with a survey for those subjects who used the mobile phone application at the 3 and 6 months period.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: Six months
• Results posted on: 2023-10-17

Participant Flow

Participant milestones

Measure	Mobile Application Diabetes Doctor This group was given the opportunity to use the mobile app: Diabetes Doctor to send in blood sugars to communicate with their physician.	Standard of Care Group This group continued to communicate with their physician regarding their blood sugars as per standard of care and routine clinic follow ups. No intervention was made.
Overall Study STARTED	3	2
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Mobile Application Diabetes Doctor This group was given the opportunity to use the mobile app: Diabetes Doctor to send in blood sugars to communicate with their physician.	Standard of Care Group This group continued to communicate with their physician regarding their blood sugars as per standard of care and routine clinic follow ups. No intervention was made.
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Effect of Mobile Phone Telemedicine on Diabetes Care

Baseline characteristics by cohort

Measure	Mobile Application Diabetes Doctor n=3 Participants The intervention group sent blood glucoses once a month using the mobile phone app, Diabetes Doctor. Subjects were seen at initial, 3 month, and 6 month visits. They received HbA1c on each visit. After 3 months, a Diabetes Quality of Life (QOL)survey was completed. A Usability and Satisfaction of Diabetes Doctor (USDD) survey was given to assess use of the mobile app. At the 3 month interval the control group will be given the opportunity to use the mobile application. QOL and USDD was given at the conclusion of the study.	Standard of Care Group n=2 Participants This group did not use the mobile app to communicate with their physician about their blood sugars. They continued with their current care.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Six months

Population: Participants withdrew from study in standard of care group

Satisfaction and usability was evaluated with a survey for those subjects who used the mobile phone application at the 3 and 6 months period.

Outcome measures

Measure	Mobile Application Diabetes Doctor n=2 Participants This group was given the opportunity to use the mobile app Diabetes Doctor to communicate with their physician about their blood sugars.	Standard of Care This group followed standard of care, did not use the mobile app Diabetes Doctor.
Evidence for Improved Diabetic Care With Mobile Phone Application Use	2 Participants	0 Participants

Adverse Events

Mobile Application Diabetes Doctor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Whitney Goldner

University of Nebraska Medical Center

Phone: 402-559-3579

Email: wgoldner@unmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place