Trial Outcomes & Findings for Effect of Inpatient Diabetes Management on Outpatient Glycemic Control (NCT NCT00869362)

NCT ID: NCT00869362

Last Updated: 2014-11-04

Results Overview

Change in glycemic control measured by HbA1c change baseline to 6 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: 6 months from discharge
• Results posted on: 2014-11-04

Participant Flow

April, 2009 to May 2010, recruited from inpatient medical and surgical general care (non-ICU) inpatient units

Participant milestones

Measure	Diabetes Management Team Evaluation and management by diabetes management team including physician and nurse practitioner CDE. Physician performed diabetes medication initiation and/or titration and nurse performed CDE focusing on Diabetes Survival Skills.	Control Patients receive usual care for diabetes
Overall Study STARTED	15	16
Overall Study COMPLETED	14	11
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Measure	Diabetes Management Team Evaluation and management by diabetes management team including physician and nurse practitioner CDE. Physician performed diabetes medication initiation and/or titration and nurse performed CDE focusing on Diabetes Survival Skills.	Control Patients receive usual care for diabetes
Overall Study Death	0	2
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

Effect of Inpatient Diabetes Management on Outpatient Glycemic Control

Baseline characteristics by cohort

Measure	Diabetes Management Team n=15 Participants Evaluation and management by diabetes management team	Control n=16 Participants Patients receive usual care for diabetes	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	57.2 years STANDARD_DEVIATION 11.3 • n=5 Participants	52.9 years STANDARD_DEVIATION 13.7 • n=7 Participants	55 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	16 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months from discharge

Change in glycemic control measured by HbA1c change baseline to 6 months

Outcome measures

Measure	Diabetes Management Team n=15 Participants Evaluation and management by diabetes management team (physician, nurse practitioner CDE) with physician-initiation and titration of diabetes medication and nurse CDE education on Diabetes Survival Skills.	Control n=16 Participants Patients receive usual care for diabetes
Hemoglobin A1c	-1.3 HbA1c, % Standard Deviation 2.3	-0.4 HbA1c, % Standard Deviation 1.1

SECONDARY outcome

Timeframe: 12 months from discharge

Outcome measures

Measure	Diabetes Management Team n=15 Participants Evaluation and management by diabetes management team (physician, nurse practitioner CDE) with physician-initiation and titration of diabetes medication and nurse CDE education on Diabetes Survival Skills.	Control n=16 Participants Patients receive usual care for diabetes
Average Intervention Effect Over 12 Months After Hospital Discharge	-0.6 HbA1c, % Standard Error 0.5	-0.6 HbA1c, % Standard Error 0.5

Adverse Events

Diabetes Management Team

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Diabetes Management Team n=15 participants at risk Evaluation and management by diabetes management team	Control n=16 participants at risk Patients receive usual care for diabetes
Cardiac disorders Death	0.00% 0/15	12.5% 2/16 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Deborah J. Wexler MD

Massachusetts General Hospital Diabetes Center

Phone: 617-726-8722

Email: dwexler@partners.org

Results disclosure agreements

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