NCT01495975

Brief Summary

The goal of this research is to evaluate the impact and feasibility of using web-based patient-provider communication and a remote glucose monitoring tool to improve post-hospitalization glycemic control and patient self-care. The investigators hypothesize that providing patients this web-based tool over a 4-week period after discharge to home will result in more effective glycemic control compared to usual care, and that patients with access to the "tool kit" will have a trend towards improved diabetes self-management and less diabetes-related distress.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 20, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 16, 2015

Completed
Last Updated

October 25, 2016

Status Verified

September 1, 2016

Enrollment Period

1.5 years

First QC Date

December 14, 2011

Results QC Date

April 6, 2015

Last Update Submit

September 12, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes MellitusDiabetes Mellitus, Type 2HospitalizationPatient Discharge

Outcome Measures

Primary Outcomes (1)

  • Glycemic Control

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

    1 month from discharge

Secondary Outcomes (3)

  • Diabetes Distress

    1 month from discharge

  • Diabetes Self-Management

    1 month from discharge

  • Unplanned Readmission or ED Visit

    1 month after discharge

Study Arms (2)

Usual Care

NO INTERVENTION

Usual care for diabetes in the 1 month after discharge.

Diabetes Transitions Tool Kit

EXPERIMENTAL

Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.

Other: Diabetes Transitions Tool Kit

Interventions

Diabetes Transitions Tool KitOTHER

Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge.

Diabetes Transitions Tool Kit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • English speaking and able to read English
  • Diagnosis of type 2 diabetes (new and pre-existing)
  • Hospital admission with endocrinology or inpatient diabetes management consult
  • On insulin during hospitalization with plan for continuation upon discharge.
  • Discharge planned for home.
  • Access to the internet and an active email account throughout the 6-week study period.

You may not qualify if:

  • Inability to connect to, navigate, and utilize the web-based system, or designate someone who is capable of using the system.
  • No identifiable outpatient healthcare provider.
  • Pregnancy, ruled out by urine hCG test after consent is obtained in all women who continue to have menstrual cycles.
  • End-stage liver disease with prothrombin time \>15 seconds and albumin \<3 mg/dL.
  • Hypoglycemia unawareness: patient lacks sensation of common signs of blood glucose \<60 mg/dL (tachycardia, diaphoresis, hunger, confusion, fatigue).
  • Projected survival \<1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Nancy Wei, MD
Organization
MGH Diabetes Center
ncwei@mgh.partners.org
617-724-7597

Study Officials

  • Nancy J Wei, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Deborah J Wexler, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 20, 2011

Study Start

December 1, 2011

Primary Completion

June 1, 2013

Study Completion

January 1, 2014

Last Updated

October 25, 2016

Results First Posted

April 16, 2015

Record last verified: 2016-09

Locations

US(1)