Type 2 Diabetes Mellitus
Conditions
Keywords
continuous glucose monitoring sensors, hospital readmission
Brief summary
Quality measures and cost-reduction methods are a high priority in the United States health care system. This includes the high burden of patients with uncontrolled Type 2 Diabetes. Innovative ways to better understand and implement diabetes management plans to reduce the burden of this disease on the system are a necessity. Use of FDA-approved continuous glucose monitoring (CGM) sensors have shown benefit in better management plans in the outpatient setting. Hence, this study hypothesizes that using CGM sensors starting in the inpatient setting will provide better and quicker understanding of the disease to make expedited changes to management plans thereby improving blood glucose control and mitigating some of the health care burden by means of reducing E.D visits and hospital re-admission rates. The study will randomly assign patients to either receive a CGM sensor plus the standard diabetes management and instructions or who will only receive the standard diabetes management. The patients will be followed in the outpatient endocrinology clinic 1-month, 3-month, and 6-month from the time of hospital discharge.
Detailed description
Rationale: Quality measures and cost-reduction methods are a high priority in the United States health care system currently. This includes the high burden of patients with uncontrolled Type 2 Diabetes on the system especially given the continued dramatic rise in the prevalence of these patients. Innovative ways to better understand and implement diabetes management plans to reduce the burden of this disease on our health care system are a necessity. The use of continuous glucose monitoring (CGM) sensors have already shown benefit in better management plans in the outpatient setting. Hence, this study aims to assess the use of CGM sensors starting in the inpatient setting and whether they will help provide better and quicker understanding of the disease to make expedited changes to management plans thereby improving blood glucose control and mitigating some of the health care burden by means of reducing E.D visits and hospital re-admission rates. Objectives: To determine whether the use of CGM sensors in patients with uncontrolled type 2 diabetes at the time of hospital discharge leads to improved glucose control and a reduction of E.D visits and hospital readmission rates. Trial Design: The trial design will be a randomized, non-blinded prospective study; a 1:1 comparison of uncontrolled type 2 diabetes patients who receive CGM sensors + conventional diabetes management at the time of discharge versus uncontrolled type 2 diabetes patients who receive only the conventional diabetes management. Study Setting: Study setting will be at the Albert Einstein Medical Center (AEMC), Philadelphia, Pennsylvania for the inpatient type 2 diabetes population who will be followed at the AEMC endocrinology clinics.
Interventions
DEVICEContinuous Glucose Monitoring Sensor
Placement of continuous glucose monitor sensor for 14 days. Instructions on how to peel off the sensor and mail it back to the clinician.
OTHERDiabetes Management Instructions
Instructions on checking fingerstick blood glucose and information on the required equipment including glucose test strips, lancets, and glucometer. Instructions on how to log blood glucose values onto the blood glucose log sheet for 14 days, and how to mail it back to the clinician.
Sponsors
Albert Einstein Healthcare Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Statistical analysis to be performed on the primary and secondary outcome measure data will be provided to the assessor without information indicating whether or not a subject received the CGM sensor.
Intervention model description
70 patients assigned to intervention group (to receive CGM sensor + conventional diabetes management); 70 patients assigned to control group (to receive only conventional diabetes management)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* inpatient uncontrolled Type 2 Diabetes patients defined by HbA1c of ≥9.0% within the last 2-3 months * require an endocrinology consultation * will be followed at AEMC endocrinology clinic
Exclusion criteria
* patients with HbA1c \<9.0% * patients not managed by AEMC endocrinology clinic * Type 1 Diabetic patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Measured at the 180-day interval post-intervention | The difference of the average changes in HbA1c from baseline between each group (intervention vs control) |
| # of E.D. visits | Within 30 days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data | Number of ED visits after the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data |
| # od hospital re-admissions | Within 30 days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data | Number of hospital re-admissions after the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c <9.0% at the end of study | Assessed at the 180-day interval from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data | \# of patients with a HbA1c \<9.0% at the end of the study compared to baseline |
| Time till first E.D. Visit | data collected for any visit occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data | Length of time until first E.D. visit from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data |
| Severity of first hypoglycemic event | data collected for any event occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data | Severity of first hypoglycemic event (based on self-management vs. need call to paramedics) from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data |
| Outpatient Visit Compliance | assessed at the 180-day interval from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data | % of patients who kept their outpatient clinic visits for diabetes (compliance) |
| Diabetes Mellitus (DM) Management change based on CGM sensor/log data | assessed within 30 days from the time the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data | % of patients whose diabetes management was changed based on CGM sensor data or blood glucose log |
| Time till first hypoglycemic event | Data collected for any event occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data | Time till first hypoglycemic from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data |
Countries
United States
Outcome results
None listed