Clinical trial NCT04729985: Diabetes Discharge Transitional CGM Study (DDT-CGM)
Official title: Daibetes Discharge Transitional CGM Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: hospital discharge
Continuous Glucose Monitoring
Type 2 diabetes
rehospitalization
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2021-01-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Trial
Primary purpose: PREVENTION

Brief summary: Intervention group will receive brief diabetic education, CGM education and use and have a CGM placed before discharge. They will also sign up for "Cloud" access of their CGM data. A medical assistant will review their CGM data daily to make sure they are using the CGM adequately. The principal investigator will review the CGM data and call the patient for a brief phone evaluation of their glucoses and their transition from the hospital to outpatient care. The will be called 4 times between discharge and day 15 by the principal investigator.

Standard treatment group will receive a blinded CGM to be reviewed 30 days after discharge.

Reduction in hospitalizations and ER visits within the first 30 days is the primary outcome. Time in range, hypoglycemia, hyperglycemia and patient satisfaction will also be evaluated 30 days after discharge.

Detailed description: Patients admitted to a community hospital with diabetes will be evaluated for being high risk for rehospitalization. High risk patients will be identified and those that are found to be high risk will be evaluated for entrance to the study and consented.

Those that consent will be randomized to two arms, an intervention arm and a standard care arm with CGM monitoring.

Intervention will include a brief 15 minute diabetic education session and a 15 minute brief education on how to use the Freestyle Libre CGM. A sensor will be placed and initiated before discharge. They will also sign up for a Freestyle Libre View account and grant access to the intervention team. The will receive a handout of reasons to call the principal investigator during the first 15 days and will be told to access the PI through the hospital operator. The PI will call the patient on day 3-4, day 5-6, day 9-10 and day 14-15 after reviewing their CGM data. The PI will review their glucoses and also any concerns from their hospitalization. The team can then help bridge any treatment or care gaps with the patients PCP or care team. The CGM data will be recorded for the first 14 days and data will be sent to the PCP.

The standard treatment arm will get 15 minutes of education on how to use the Libre Pro blinded CGM sensor and the sensor will be placed before discharge. The sensor will be sent back the the team and downloaded. After 30 days the data will be sent to the patients PCP.

Outcomes will be measured for 30 days from discharge.

Patient satisfaction will be measured by a phone interview in both groups once after 31-40 days from discharge

Eligibility criteria: Inclusion Criteria:

Type 2 diabetes plus one additional criteria during hospitalization:

A1C greater than or equal to 9, New diagnosis of diabetes Type 2 and A1C greater than or equal to 8, On insulin, On sulfonylurea, Deemed to by high risk by hospitalist staff for post-hospitalization complications, Acute Heart Failure, Acute Coronary Syndrome (ACS), Stroke, or a TIA.

-

Exclusion Criteria:

Type 1 Diabetes, or Not high risk (as above), or Already using a CGM, or Unable to understand or use a CGM, or Unable or unwilling to use a CGM, or Participating in another clinical trial within 30 days.

-

Primary outcomes:
measure: Emergency room visit and rehospitalization
timeFrame: Within 30 days after discharge from the hospital
Secondary outcomes:
measure: Emergency room visits
timeFrame: Within 30 days after discharge from the hospital
measure: Rehospitalizations
timeFrame: Within 30 days after discharge from the hospital
measure: Time in range
timeFrame: From discharge to day 14
measure: time in hypoglycemia
timeFrame: from discharge through day 14
measure: Severe hypoglycemia
timeFrame: from discharge to day 30
measure: time in hyperglycemia
timeFrame: From discharge through day 14
measure: time in severe hyperglycemia
timeFrame: from discharge through day 14
measure: Patient satisfaction
timeFrame: survey will be done between 31 and 40 days after hospital discharge
Other outcomes:
Locations:
city: Logan
country: United States
facility: Logan Regional Hospital
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Christopher Jones, MD
role: PRINCIPAL_INVESTIGATOR
References: