Trial Outcomes & Findings for Evaluation of a Diabetes Data Management System (NCT NCT00694070)

NCT ID: NCT00694070

Last Updated: 2016-02-29

Results Overview

After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5. 1. Very Simple 2. Simple 3. Neither simple nor difficult 4. Difficult 5. Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3.

• Recruitment status: COMPLETED
• Target enrollment: 51 participants
• Primary outcome timeframe: 1-2 hours
• Results posted on: 2016-02-29

Participant Flow

Participant milestones

Measure	Health Care Professionals and Lay Users h= 8 health care professionals p= 43 lay users
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Diabetes Data Management System

Baseline characteristics by cohort

Measure	Health Care Professionals and Lay Users n=51 Participants h= 8 health care professionals p= 43 lay users
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-2 hours

Population: per protocol

After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5.

1. Very Simple

2. Simple

3. Neither simple nor difficult

4. Difficult

5. Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3.

Outcome measures

Measure	Health Care Professionals and Lay Users n=51 Participants h= 8 health care professionals p= 43 lay users
Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)	46 Participants

PRIMARY outcome

Timeframe: 1-2 hours

Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was:

1. successful

2. successful after being referred to user instructions

3. success with assistance (similar to a customer call)

4. unsuccessful 5 = software problem Outcome measure was the number of participants rated as <= 3.

Outcome measures

Measure	Health Care Professionals and Lay Users n=51 Participants h= 8 health care professionals p= 43 lay users
Number of Participants Rated as <= 3 (Success in Using the Program)	50 Participants

PRIMARY outcome

Timeframe: 1-2 hours

Subjects were asked thirty questions throughout the evaluation to test whether they understood the data displays, graphs and features of the software. Outcome measure was the number of participants that could answer at least 85% of the comprehension questions correctly.

Outcome measures

Measure	Health Care Professionals and Lay Users n=51 Participants h= 8 health care professionals p= 43 lay users
Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)	50 participants

Adverse Events

Health Care Professionals and Lay Users

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

Clinical Research Scientist

Ascensia Diabetes Care

Phone: 574-257-3063

Results disclosure agreements

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