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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Diabetes Transitions Tool Kit

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Usual care for diabetes in the 1 month after discharge.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Control	Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge	1 month from discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Distress	Measured by the Problem Areas in Diabetes (PAID) Questionnaire	1 month from discharge
Diabetes Self-Management		1 month from discharge
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

Collaborators and Investigators

• Sponsor: Deborah Wexler, MD
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Nancy J Wei, MD, Massachusetts General Hospital; Principal Investigator: Deborah J Wexler, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: December 14, 2011
• First Submitted That Met QC Criteria: December 16, 2011
• First Posted (Estimate): December 20, 2011

Study Record Updates

• Last Update Posted (Estimate): October 25, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hospitalization; Patient Discharge
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2011p-001573; 5K23DK080228-05 (U.S. NIH Grant/Contract)