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Active, Not Recruiting

NCT Number: NCT04729985

Diabetes Discharge Transitional CGM Study (DDT-CGM)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Logan Regional Hospital

Logan, Utah, 84321, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

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

Other names: Blind CGM

Primary outcomes

  1. Emergency room visit and rehospitalization

    Time frame: Within 30 days after discharge from the hospital

    Total Emergency room visits and total rehospitalizations

Secondary outcomes

  1. Emergency room visits

    Time frame: Within 30 days after discharge from the hospital

    Total Emergency room visits

  2. Rehospitalizations

    Time frame: Within 30 days after discharge from the hospital

    Total Rehospitalizations

  3. Time in range

    Time frame: From discharge to day 14

    percent of time glucose is in range from 70-180 mg/dl as measured by CGM

  4. time in hypoglycemia

    Time frame: from discharge through day 14

    amount of time below 70 mg/dl as measured by CGM

  5. Severe hypoglycemia

    Time frame: from discharge to day 30

    hypoglycemia requiring the assistance from another person

  6. time in hyperglycemia

    Time frame: From discharge through day 14

    glucose from 181-250 mg/dl as measured by CGM

  7. time in severe hyperglycemia

    Time frame: from discharge through day 14

    glucose greater than 251 mg/dl as measured by CGM

  8. Patient satisfaction

    Time frame: survey will be done between 31 and 40 days after hospital discharge

    Patient telephone questionnaire about patient satisfaction during the transition phase

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Collaborators

  • Abbott

Registry information

Official study title

Daibetes Discharge Transitional CGM Study

Acronym: DDT-CGM

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2021
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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