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Diabetes Discharge Transitional CGM Study (DDT-CGM) (DDT-CGM)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CGM device with diabetic education, CGM education and a follow up protocol.
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring hospital discharge, Continuous Glucose Monitoring, Type 2 diabetes, rehospitalization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

-

Sites / Locations

  • Logan Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard Care

Diabetic education and CGM monitoring

Arm Description

A blinded CGM will be placed to review glucoses after discharge in the Standard Care arm.

Treatment arm will get diabetic education, active CGM use with patient feedback for 14 days, active access to the PI for concerns relating to hospitalization. They will also receive a brief, 15 minute phone call from the PI on day 3-4, 6-7, 9-10 and day 14-15.

Outcomes

Primary Outcome Measures

Emergency room visit and rehospitalization
Total Emergency room visits and total rehospitalizations

Secondary Outcome Measures

Emergency room visits
Total Emergency room visits
Rehospitalizations
Total Rehospitalizations
Time in range
percent of time glucose is in range from 70-180 mg/dl as measured by CGM
time in hypoglycemia
amount of time below 70 mg/dl as measured by CGM
Severe hypoglycemia
hypoglycemia requiring the assistance from another person
time in hyperglycemia
glucose from 181-250 mg/dl as measured by CGM
time in severe hyperglycemia
glucose greater than 251 mg/dl as measured by CGM
Patient satisfaction
Patient telephone questionnaire about patient satisfaction during the transition phase

Full Information

First Posted
January 25, 2021
Last Updated
March 12, 2023
Sponsor
Intermountain Health Care, Inc.
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT04729985
Brief Title
Diabetes Discharge Transitional CGM Study (DDT-CGM)
Acronym
DDT-CGM
Official Title
Daibetes Discharge Transitional CGM Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Intermountain Health Care, Inc.
Collaborators
Abbott

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
hospital discharge, Continuous Glucose Monitoring, Type 2 diabetes, rehospitalization

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized Trial
Masking
Outcomes Assessor
Masking Description
Data evaluation group will be blinded as to which arm the data comes from
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
A blinded CGM will be placed to review glucoses after discharge in the Standard Care arm.
Arm Title
Diabetic education and CGM monitoring
Arm Type
Active Comparator
Arm Description
Treatment arm will get diabetic education, active CGM use with patient feedback for 14 days, active access to the PI for concerns relating to hospitalization. They will also receive a brief, 15 minute phone call from the PI on day 3-4, 6-7, 9-10 and day 14-15.
Intervention Type
Device
Intervention Name(s)
CGM device with diabetic education, CGM education and a follow up protocol.
Other Intervention Name(s)
Blind CGM
Intervention Description
Blind CGM placed and recorded for 14 days after discharge and data downloaded
Primary Outcome Measure Information:
Title
Emergency room visit and rehospitalization
Description
Total Emergency room visits and total rehospitalizations
Time Frame
Within 30 days after discharge from the hospital
Secondary Outcome Measure Information:
Title
Emergency room visits
Description
Total Emergency room visits
Time Frame
Within 30 days after discharge from the hospital
Title
Rehospitalizations
Description
Total Rehospitalizations
Time Frame
Within 30 days after discharge from the hospital
Title
Time in range
Description
percent of time glucose is in range from 70-180 mg/dl as measured by CGM
Time Frame
From discharge to day 14
Title
time in hypoglycemia
Description
amount of time below 70 mg/dl as measured by CGM
Time Frame
from discharge through day 14
Title
Severe hypoglycemia
Description
hypoglycemia requiring the assistance from another person
Time Frame
from discharge to day 30
Title
time in hyperglycemia
Description
glucose from 181-250 mg/dl as measured by CGM
Time Frame
From discharge through day 14
Title
time in severe hyperglycemia
Description
glucose greater than 251 mg/dl as measured by CGM
Time Frame
from discharge through day 14
Title
Patient satisfaction
Description
Patient telephone questionnaire about patient satisfaction during the transition phase
Time Frame
survey will be done between 31 and 40 days after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas H Clark, MD
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Logan Regional Hospital
City
Logan
State/Province
Utah
ZIP/Postal Code
84321
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Diabetes Discharge Transitional CGM Study (DDT-CGM)

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