Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Diabetes Mellitus, Type 2, Hospitalization, Patient Discharge
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.
Interventions
OTHERDiabetes 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Deborah Wexler, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control | 1 month from discharge | Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Distress | 1 month from discharge | Measured by the Problem Areas in Diabetes (PAID) Questionnaire |
| Diabetes Self-Management | 1 month from discharge | — |
| Unplanned Readmission or ED Visit | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual care for diabetes in the 1 month after discharge. | 14 |
| 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.
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. | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Usual Care | Diabetes Transitions Tool Kit | Total |
|---|---|---|---|
| Age, Customized Age | 52 years STANDARD_DEVIATION 14 | 54 years STANDARD_DEVIATION 16 | 53 years STANDARD_DEVIATION 15 |
| Average glycated albumin | 30 % STANDARD_DEVIATION 10 | 26 % STANDARD_DEVIATION 7 | 28 % STANDARD_DEVIATION 8.7 |
| Average HbA1c | 10.2 % STANDARD_DEVIATION 2.4 | 10.5 % STANDARD_DEVIATION 1.9 | 10.3 % STANDARD_DEVIATION 2.2 |
| Race/Ethnicity, Customized Hispanic | 1 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Other | 5 participants | 3 participants | 8 participants |
| Race/Ethnicity, Customized White | 8 participants | 8 participants | 16 participants |
| Region of Enrollment United States | 14 participants | 14 participants | 28 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 11 Participants | 9 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Glycemic Control
Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge
Time frame: 1 month from discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Glycemic Control | 144 mg/dL | Standard Deviation 34 |
| Diabetes Transitions Tool Kit | Glycemic Control | 172 mg/dL | Standard Deviation 41 |
Secondary
Diabetes Distress
Measured by the Problem Areas in Diabetes (PAID) Questionnaire
Time frame: 1 month from discharge
Secondary
Diabetes Self-Management
Time frame: 1 month from discharge
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.
Time frame: 1 month after discharge