Trial Outcomes & Findings for New Ways to Help Patients Improve Their Diabetes Control (NCT NCT01143870)

NCT ID: NCT01143870

Last Updated: 2018-02-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 177 participants
• Primary outcome timeframe: 6 months from enrollment
• Results posted on: 2018-02-28

Participant Flow

Participant milestones

Measure	Control Received information on diabetes control using the standard hemoglobin A1c value	Letter Grades Received information on diabetes control translated into a letter grade, ranging from A-F	Faces Received information on diabetes control translated into a emoticon, ranging from smiling to crying
Overall Study STARTED	58	58	61
Overall Study Post-intervention Survey	53	50	61
Overall Study Had Available 6-month A1C	27	29	31
Overall Study A1C Imputed	31	29	30
Overall Study COMPLETED	58	58	61
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

New Ways to Help Patients Improve Their Diabetes Control

Baseline characteristics by cohort

Measure	Control n=58 Participants Received information on diabetes control using the standard hemoglobin A1c value	Letter Grades n=58 Participants Received information on diabetes control translated into a letter grade, ranging from A-F	Faces n=61 Participants Received information on diabetes control translated into a emoticon, ranging from smiling to crying	Total n=177 Participants Total of all reporting groups
Age, Continuous	56.6 years STANDARD_DEVIATION 3.3 • n=5 Participants	57.8 years STANDARD_DEVIATION 3.1 • n=7 Participants	55 years STANDARD_DEVIATION 3.5 • n=5 Participants	56.4 years STANDARD_DEVIATION 1.9 • n=4 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	45 Participants n=7 Participants	44 Participants n=5 Participants	130 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants	47 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	48 Participants n=5 Participants	50 Participants n=7 Participants	48 Participants n=5 Participants	146 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	23 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months from enrollment

Outcome measures

Measure	Control n=58 Participants Received information on diabetes control using the standard hemoglobin A1c value	Letter Grades n=58 Participants Received information on diabetes control translated into a letter grade, ranging from A-F	Faces n=61 Participants Received information on diabetes control translated into a emoticon, ranging from smiling to crying
Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment	-0.74 Percent of glycosylated hemoglobin Standard Error 0.37	-0.55 Percent of glycosylated hemoglobin Standard Error 0.3	-0.89 Percent of glycosylated hemoglobin Standard Error 0.3

SECONDARY outcome

Timeframe: 2 weeks on average

Change in patient understanding of disease state as assessed by questionnaire administered pre- and post-intervention.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Letter Grades

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Faces

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

Anjali Gopalan

University of Pennsylvania

Phone: 575-640-3893

Email: agopalan@upenn.edu

Results disclosure agreements

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