Diabetes Mellitus, Type 2DDT-CGMNCT04729985
Diabetes Discharge Transitional CGM Study (DDT-CGM)
A study testing CGM device with diabetic education, CGM education and a follow up protocol. in people with Diabetes Mellitus, Type 2, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- CGM device with diabetic education, CGM education and a follow up protocol.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Daibetes Discharge Transitional CGM Study
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.
Read the 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
- Being tested
- CGM device with diabetic education, CGM education and a follow up protocol.
- Keywords
- hospital discharge, Continuous Glucose Monitoring, Type 2 diabetes, rehospitalization
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM device with diabetic education, CGM education and a follow up protocol.Device
Also called Blind CGM
Blind CGM placed and recorded for 14 days after discharge and data downloaded
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CGM device with diabetic education, CGM education and a follow up protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency room visit and rehospitalization
Total Emergency room visits and total rehospitalizations
Measured: Within 30 days after discharge from the hospital
Secondary outcomes (8)
Emergency room visits
Total Emergency room visits
Measured: Within 30 days after discharge from the hospital
Rehospitalizations
Total Rehospitalizations
Measured: Within 30 days after discharge from the hospital
Time in range
percent of time glucose is in range from 70-180 mg/dl as measured by CGM
Measured: From discharge to day 14
time in hypoglycemia
amount of time below 70 mg/dl as measured by CGM
Measured: from discharge through day 14
Severe hypoglycemia
hypoglycemia requiring the assistance from another person
Measured: from discharge to day 30
time in hyperglycemia
glucose from 181-250 mg/dl as measured by CGM
Measured: From discharge through day 14
time in severe hyperglycemia
glucose greater than 251 mg/dl as measured by CGM
Measured: from discharge through day 14
Patient satisfaction
Patient telephone questionnaire about patient satisfaction during the transition phase
Measured: survey will be done between 31 and 40 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Jun 2021
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Christopher Jones, Intermountain Health Care, Inc.
- Investigators
- Christopher Jones, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729985
- Sponsor's protocol ID
- 1051438
- Acronym
- DDT-CGM
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2021
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daibetes Discharge Transitional CGM Study
- ClinicalTrials.gov ID
- NCT04729985
- Acronym / sponsor ID
- DDT-CGM / 1051438
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- hospital discharge, Continuous Glucose Monitoring, Type 2 diabetes, rehospitalization
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Abbott
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: CGM device with diabetic education, CGM education and a follow up protocol.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- -
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGM device with diabetic education, CGM education and a follow up protocol.Also: Blind CGMBlind CGM placed and recorded for 14 days after discharge and data downloaded | Device | Diabetic education and CGM monitoring |
Primary outcome
Emergency room visit and rehospitalization
Time frame: Within 30 days after discharge from the hospital
Total Emergency room visits and total rehospitalizations
8 secondary outcomes
Emergency room visits
Time frame: Within 30 days after discharge from the hospital
Rehospitalizations
Time frame: Within 30 days after discharge from the hospital
Time in range
Time frame: From discharge to day 14
time in hypoglycemia
Time frame: from discharge through day 14
Severe hypoglycemia
Time frame: from discharge to day 30
time in hyperglycemia
Time frame: From discharge through day 14
time in severe hyperglycemia
Time frame: from discharge through day 14
Patient satisfaction
Time frame: survey will be done between 31 and 40 days after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Jones, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM device with diabetic education, CGM education and a follow up protocol. in people with Diabetes Mellitus, Type 2, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency room visit and rehospitalization (time frame: Within 30 days after discharge from the hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.