Trial Outcomes & Findings for Impact of a Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control (NCT NCT01495975)

Results Overview

Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

1 month from discharge

Results posted on

2016-10-25

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care Usual care for diabetes in the 1 month after discharge.	Diabetes Transitions Tool Kit Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge. Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge.
Overall Study STARTED	15	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Usual care for diabetes in the 1 month after discharge.	Diabetes Transitions Tool Kit Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge. Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Impact of a Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=14 Participants Usual care for diabetes in the 1 month after discharge.	Diabetes Transitions Tool Kit n=14 Participants Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge. Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge.	Total n=28 Participants Total of all reporting groups
Age, Customized Age	52 years STANDARD_DEVIATION 14 • n=5 Participants	54 years STANDARD_DEVIATION 16 • n=7 Participants	53 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized White	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Other	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants
Average HbA1c	10.2 % STANDARD_DEVIATION 2.4 • n=5 Participants	10.5 % STANDARD_DEVIATION 1.9 • n=7 Participants	10.3 % STANDARD_DEVIATION 2.2 • n=5 Participants
Average glycated albumin	30 % STANDARD_DEVIATION 10 • n=5 Participants	26 % STANDARD_DEVIATION 7 • n=7 Participants	28 % STANDARD_DEVIATION 8.7 • n=5 Participants

PRIMARY outcome

Timeframe: 1 month from discharge

Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge

Outcome measures

Outcome measures
Measure	Usual Care n=14 Participants Usual care for diabetes in the 1 month after discharge.	Diabetes Transitions Tool Kit n=14 Participants Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge. Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge.
Glycemic Control	144 mg/dL Standard Deviation 34	172 mg/dL Standard Deviation 41

SECONDARY outcome

Timeframe: 1 month from discharge

Measured by the Problem Areas in Diabetes (PAID) Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month from discharge

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month after discharge

Unplanned readmission to any hospital within 30 days of discharge. Emergency department admission to any hospital within 30 days of discharge.

Outcome measures

Outcome data not reported

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diabetes Transitions Tool Kit

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

Nancy Wei, MD

MGH Diabetes Center

Phone: 617-724-7597

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place