Diabetes Discharge Transitional CGM Study (DDT-CGM)

NCT04729985 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 1051438
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

hospital discharge; Continuous Glucose Monitoring; Type 2 diabetes; rehospitalization

Outcome Measures

Primary Outcomes (1)

• Emergency room visit and rehospitalization

  Total Emergency room visits and total rehospitalizations

  Within 30 days after discharge from the hospital

Secondary Outcomes (8)

• Emergency room visits

  Within 30 days after discharge from the hospital

• Rehospitalizations

  Within 30 days after discharge from the hospital

• Time in range

  From discharge to day 14

• time in hypoglycemia

  from discharge through day 14

• Severe hypoglycemia

  from discharge to day 30

Study Arms (2)

Standard Care

NO INTERVENTION

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

Diabetic education and CGM monitoring

ACTIVE COMPARATOR

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.

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

Interventions

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

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

Also known as: Blind CGM

Diabetic education and CGM monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Abbott: collaborator

Study Sites (1)

Logan Regional Hospital

Logan, Utah, 84321, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Christopher Jones, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data evaluation group will be blinded as to which arm the data comes from
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective Randomized Trial

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 29, 2021
• Study Start: June 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)