Effect of Mobile Phone Telemedicine on Diabetes Care

NCT01698008 | Completed Results DMC

• 1 other identifier: 0396-12-FB
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Mobile application Diabetes Doctor

EXPERIMENTAL

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.

Other: Diabetes Doctor Mobile app

Standard of Care

NO INTERVENTION

The standard of care arm will not use the mobile application Diabetes Doctor to communicate with their physician about their blood sugars. They will attend clinic visits and have evaluations initially, and at 3 and 6 months. They will also receive a HbAIc at each visit. They will do the same QOL survey at 3 months. At 6 months, they will be given the QOL survey.

Interventions

Diabetes Doctor Mobile app OTHER

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.

Mobile application Diabetes Doctor

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Type 2 diabetics using only oral medications
• Do not own or know how to operate an iPhone

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

The University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Overall, there were difficulties with this study. We only had a small number of patients interested in participating and those that were given standard of care treatment did not continue on with the study.

Results Point of Contact

• Title: Whitney Goldner
• Organization: University of Nebraska Medical Center

wgoldner@unmc.edu

402-559-3579

Study Officials

• Whitney S Goldner, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group is standard of care. The other is given the opportunity to use a new mobile app for reporting blood sugars.

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 2, 2012
• Study Start: January 28, 2012
• Primary Completion: September 25, 2013
• Study Completion: September 25, 2013
• Last Updated: October 17, 2023
• Results First Posted: November 2, 2018

Record last verified: 2023-10

Locations

US (1)