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

NCT ID: NCT01495975

Last Updated: 2016-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-01-31

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.

Detailed Description

Diabetes affects 12-25% of all hospitalized adult patients, and 30% of hospitalized diabetes patients have one or more readmissions within one year. While glycemic control is rarely the primary reason for admission, poor glycemic control has been associated with increased rates of hospitalization and worse clinical outcomes, including infections, poor wound healing, and death. Hospitalization has been proposed as a "teachable moment" for patients with diabetes, as they have intensive contact with a full range of expert clinicians, but the effects of changes implemented during hospitalization after discharge are poorly studied.

The objective of this study is to conduct a randomized controlled trial to test a novel approach to diabetes management in the transition from inpatient to outpatient care. We will assign 40 hospitalized adult patients with type 2 diabetes to usual care or access to a web-based patient-provider communication and remote glucose monitoring tool ("Diabetes Transitions Tool Kit"). Our aims are to evaluate feasibility of implementation of the tool as well as impact on post-discharge glycemic control, diabetes-related self-care and distress. We 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. Feasibility and preliminary data from this pilot study will be the foundation for larger-scale interventions that may ultimately improve the delivery of diabetes care in the transition from hospital to home.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

Usual care for diabetes in the 1 month after discharge.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Diabetes Transitions Tool Kit

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Deborah Wexler, MD

OTHER

Sponsor Role: lead

Responsible Party

Deborah Wexler, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nancy J Wei, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Deborah J Wexler, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

5K23DK080228-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011p-001573

Identifier Type: -

Identifier Source: org_study_id