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

Diabetes Mellitus, Type 2 Clinical Trial

— DTTK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495975
• Other study ID #: 2011p-001573
• Secondary ID: 5K23DK080228-05
• Status: Completed
• Phase: N/A
• First received: December 14, 2011
• Last updated: April 6, 2015
• Start date: December 2011
• Est. completion date: January 2014

Study information

• Verified date: April 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Deborah Wexler, MD	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control	Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge	1 month from discharge	No
Secondary	Diabetes Distress	Measured by the Problem Areas in Diabetes (PAID) Questionnaire	1 month from discharge	No
Secondary	Diabetes Self-Management		1 month from discharge	No
Secondary	Unplanned Readmission or ED Visit	Unplanned readmission to any hospital within 30 days of discharge. Emergency department admission to any hospital within 30 days of discharge.	1 month after discharge	No