Diabetes Mellitus, Type 2DTTKNCT01495975
Impact of a Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control
A study testing Diabetes Transitions Tool Kit in people with Diabetes Mellitus, Type 2, run by Deborah Wexler, MD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Diabetes Transitions Tool Kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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
- Being tested
- Diabetes Transitions Tool Kit
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Hospitalization, Patient Discharge
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Diabetes Transitions Tool Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control
Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge
Measured: 1 month from discharge
Secondary outcomes (3)
Diabetes Distress
Measured by the Problem Areas in Diabetes (PAID) Questionnaire
Measured: 1 month from discharge
Diabetes Self-Management
Measured: 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.
Measured: 1 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deborah Wexler, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deborah Wexler, MD, Massachusetts General Hospital
- Investigators
- Nancy J Wei, MD, Principal investigator, Massachusetts General HospitalDeborah J Wexler, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495975
- Sponsor's protocol ID
- 2011p-001573
- Other IDs
- 5K23DK080228-05
- Acronym
- DTTK
- Status last verified
- Sep 2016
- First submitted
- 14 Dec 2011
- Last updated
- 25 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Web-based Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control
- ClinicalTrials.gov ID
- NCT01495975
- Acronym / sponsor ID
- DTTK / 2011p-001573
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Hospitalization, Patient Discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Deborah Wexler, MDUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Dec 2011 (estimated)
- Results
- Posted 16 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care for diabetes in the 1 month after discharge. |
| Diabetes Transitions Tool Kit | Experimental | Other: Diabetes Transitions Tool KitRemote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Transitions Tool KitAccess to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge. | Other | Diabetes Transitions Tool Kit |
Primary outcome
Glycemic Control
Time frame: 1 month from discharge
Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge
3 secondary outcomes
Diabetes Distress
Time frame: 1 month from discharge
Diabetes Self-Management
Time frame: 1 month from discharge
Unplanned Readmission or ED Visit
Time frame: 1 month after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy J Wei, MD principal investigator
Massachusetts General Hospital
Deborah J Wexler, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Transitions Tool Kit in people with Diabetes Mellitus, Type 2, run by Deborah Wexler, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control (time frame: 1 month from discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.