Skip to main content
OpenTrials
Completed

NCT Number: NCT01495975

Impact of a 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diabetes Transitions Tool Kit

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.

Primary outcomes

  1. Glycemic Control

    Time frame: 1 month from discharge

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

Secondary outcomes

  1. Diabetes Distress

    Time frame: 1 month from discharge

    Measured by the Problem Areas in Diabetes (PAID) Questionnaire

  2. Diabetes Self-Management

    Time frame: 1 month from discharge

  3. Unplanned Readmission or ED Visit

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Deborah Wexler, MD

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DTTK

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Dec 20, 2011
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.