Diabetes Mellitus
Conditions
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.
Interventions
OTHERDiabetes 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.
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mobile Application Diabetes Doctor 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. | 3 |
| Standard of Care Group This group did not use the mobile app to communicate with their physician about their blood sugars. They continued with their current care. | 2 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Mobile Application Diabetes Doctor | Standard of Care Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 3 participants | 2 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 |
Outcome results
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.
Time frame: Six months
Population: Participants withdrew from study in standard of care group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Application Diabetes Doctor | Evidence for Improved Diabetic Care With Mobile Phone Application Use | 2 Participants |
| Standard of Care | Evidence for Improved Diabetic Care With Mobile Phone Application Use | 0 Participants |