Evaluation of a Diabetes Data Management System - Study Results

Study Type:	Observational
Study Design:	Observational Model: Case-Only; Time Perspective: Cross-Sectional
Condition:	Diabetes

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Health Care Professionals and Lay Users	h= 8 health care professionals p= 43 lay users

Participant Flow: Overall Study

	Health Care Professionals and Lay Users
STARTED	51
COMPLETED	51
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Health Care Professionals and Lay Users	h= 8 health care professionals p= 43 lay users

Baseline Measures

	Health Care Professionals and Lay Users
Number of Participants [units: participants]	51
Age [units: years] Median ( Full Range )	53 ( 18 to 82 )
Gender [units: participants]
Female	29
Male	22

Outcome Measures

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1. Primary:

Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program) [ Time Frame: 1-2 hours ]

Measure Type	Primary
Measure Title	Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)
Measure Description	After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5. Very Simple Simple Neither simple nor difficult Difficult Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3.
Time Frame	1-2 hours
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
per protocol

Reporting Groups

	Description
Health Care Professionals and Lay Users	h= 8 health care professionals p= 43 lay users

Measured Values

	Health Care Professionals and Lay Users
Number of Participants Analyzed [units: participants]	51
Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program) [units: Participants]	46

Statistical Analysis 1 for Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)

Groups ^[1]	Health Care Professionals and Lay Users
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	Exact binomial test
P Value ^[4]	0.0421

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	The null and alternative hypotheses for these tests will have the form: Ho: Pr{Success} < Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 80%, with n=51, critical number is 38. With this critical value and sample size, the power to reject Ho is approximately 87.43%.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

2. Primary:

Number of Participants Rated as <= 3 (Success in Using the Program) [ Time Frame: 1-2 hours ]

Measure Type	Primary
Measure Title	Number of Participants Rated as <= 3 (Success in Using the Program)
Measure Description	Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was: successful successful after being referred to user instructions success with assistance (similar to a customer call) unsuccessful 5 = software problem Outcome measure was the number of participants rated as <= 3.
Time Frame	1-2 hours
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Health Care Professionals and Lay Users	h= 8 health care professionals p= 43 lay users

Measured Values

	Health Care Professionals and Lay Users
Number of Participants Analyzed [units: participants]	51
Number of Participants Rated as <= 3 (Success in Using the Program) [units: Participants]	50

Statistical Analysis 1 for Number of Participants Rated as <= 3 (Success in Using the Program)

Groups ^[1]	Health Care Professionals and Lay Users
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	Exact binomial test
P Value ^[4]	0.0309

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	The null and alternative hypotheses for these tests will have the form: Ho: Pr{Success} < Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 95%, with n=51, critical number is 47. With this critical value and sample size, the power to reject Ho is approximately 88.96%.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

3. Primary:

Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports) [ Time Frame: 1-2 hours ]

Measure Type	Primary
Measure Title	Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)
Measure Description	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.
Time Frame	1-2 hours
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Health Care Professionals and Lay Users	h= 8 health care professionals p= 43 lay users

Measured Values

	Health Care Professionals and Lay Users
Number of Participants Analyzed [units: participants]	51
Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports) [units: participants]	50

Statistical Analysis 1 for Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)

Groups ^[1]	Health Care Professionals and Lay Users
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	Exact binomial test
P Value ^[4]	0.0309

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	The null and alternative hypotheses for these tests will have the form: Ho: Pr{Success} < Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 90%, with n=51, critical number is 43. With this critical value and sample size, the power to reject Ho is approximately 93.57%.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Clinical Research Scientist
Organization: Bayer Healthcare, Diabetes Care
phone: 574-257-3063

No publications provided

Responsible Party:	Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:	NCT00694070 History of Changes
Other Study ID Numbers:	CTD-2008-11
Study First Received:	June 6, 2008
Results First Received:	July 1, 2009
Last Updated:	January 26, 2012
Health Authority:	United States: Institutional Review Board