Diabetes Discharge Transitional CGM Study (DDT-CGM)

NCT ID: NCT04729985

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2024-12-01

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Standard Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Diabetic education and CGM monitoring

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.

Group Type: ACTIVE_COMPARATOR

CGM device with diabetic education, CGM education and a follow up protocol.

Intervention Type: DEVICE

Blind CGM placed and recorded for 14 days after discharge and data downloaded

Interventions

CGM device with diabetic education, CGM education and a follow up protocol.

Blind CGM placed and recorded for 14 days after discharge and data downloaded

Intervention Type: DEVICE

Other Intervention Names

Blind CGM

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.

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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.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Christopher Jones

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Jones, MD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Health Care, Inc.

Locations

Logan Regional Hospital

Logan, Utah, United States

Countries

United States

Other Identifiers

1051438

Identifier Type: -

Identifier Source: org_study_id