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Effect of Mobile Phone Telemedicine on Diabetes Care

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ClinicalTrials.gov Identifier: NCT01698008
Recruitment Status : Completed
First Posted : October 2, 2012
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Whitney Goldner, MD, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Diabetes Doctor Mobile app Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One group is standard of care. The other is given the opportunity to use a new mobile app for reporting blood sugars.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Mobile Phone Telemedicine on Diabetes Care
Actual Study Start Date : December 2012
Actual Primary Completion Date : September 25, 2013
Actual Study Completion Date : September 25, 2013

Arm Intervention/treatment
Experimental: Mobile application Diabetes Doctor
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
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.

No Intervention: Standard of Care
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.



Primary Outcome Measures :
  1. Evidence for Improved Diabetic Care With Mobile Phone Application Use [ Time Frame: 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.



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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698008


Locations
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United States, Nebraska
The University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Whitney S Goldner, M.D. University of Nebraska

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Responsible Party: Whitney Goldner, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01698008     History of Changes
Other Study ID Numbers: 396-12-FB
First Posted: October 2, 2012    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases