Blood Glucose ProfileNCT04306848
Temporary Use of a Continuous Glucose Monitoring System as an Adjunct to Lifestyle Medicine Education
A study testing Temporary Continuous Glucose Monitoring System in people with Blood Glucose Profile, run by Ohio University at 1 site in United States.
Trial summary
This is a feasibility study evaluating the potential to utilize a continuous glucose monitoring system (CGMs) on a temporary basis, during participation in a lifestyle medicine program, to help improve the compliance with healthy lifestyle changes for people with Type 2 diabetes (T2DM) and prediabetes (PD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Glucose Profile
- What is being tested?
- Temporary Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be able to read and write English.
- be enrolled in The Lifestyle Medicine Clinic, taught by Dr. Drozek
- be diagnosed with type 2 diabetes (T2DM) or prediabetes (PDM)
- be at least 18 years of age
- be comfortable wearing a sensor continuously for up to 10 weeks
- have a smart phone and be comfortable utilizing apps
Show all 9Show fewer
- be able and willing to daily enter data concerning food consumed, exercise, stress management activities and sleep.
- be willing to complete a daily reflection on the relationship of their blood sugar to lifestyle activities.
- be willing to complete a survey at the completion of the project about their perceptions of utilizing continuous glucose monitoring (CGM)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporary Use of a Continuous Glucose Monitoring System as an Adjunct to Lifestyle Medicine Education for People With Type 2 Diabetes: a Feasibility Study.
This is a feasibility study evaluating the potential to utilize a continuous glucose monitoring system (CGMs) on a temporary basis, during participation in a lifestyle medicine program, to help improve the compliance with healthy lifestyle changes for people with Type 2 diabetes (T2DM) and prediabetes (PD).
Read the detailed description
Glucose peaks after eating are an indication of the level of insulin resistance and the severity of disease in patients with T2DM. Many lifestyle factors affect the glucose elevation, including the glycemic index of food, timing of eating, physical activity, stress and sleep.
In practice, a glycemic profile, consisting of multiple glucose measurements before and after meals throughout the day, has sometimes been helpful in educating patients concerning the effects of their eating habits on blood sugar levels.
Would temporary use (8-10 weeks) of a continuous glucose monitoring system (CGMs) be a useful adjunct during lifestyle education in patients with T2DM or PD?
The purpose of this feasibility study is to evaluate the effectiveness of a CGMs on a small sample of patients while they are enrolled in a lifestyle medicine class, to:
- identify any logistical issue involved
- verify that useful data can be obtained for analysis
- inform development of a larger controlled study
Eligible subjects who have consented to the study, and have had the baseline data gathered as part of their participation in the Lifestyle Medicine Clinic, will be given a CGMs device and supplies, and instructed in how to utilize these. They will set up the app on their smart phone to provide them with feedback on their glucose level to correlate with their lifestyle activities.
The FDA approved CGMs utilizes a small filament-like probe that is entered into the skin and measures sugar levels of the interstitial fluid of the subcutaneous tissue. This correlates with blood glucose levels.
Daily, the subjects will enter data into their smart phone app, which will include:
- time of arising in the morning, and perceived quality of sleep
- time and description of food and beverages consumed
- time and description of physical activity
- time and description of stress management activities
- time and duration of naps
- bedtime
Once daily, the subject will complete a reflection entry in a diary on their glucose levels over the last 24 hours in relation to their logged lifestyle activities.
At the completion of the 8 sessions of The Lifestyle Medicine Clinic, participants will complete a survey asking open ended question concerning the use of the CGMs.
- Conditions
- Blood Glucose Profile
- Being tested
- Temporary Continuous Glucose Monitoring System
- Keywords
- continuous glucose monitoring, lifestyle medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary Continuous Glucose Monitoring SystemDevice
Also called Intensive therapeutic lifestyle medicine
This is a feasibility study evaluating the potential to utilize a continuous glucose monitoring system (CGMs) on a temporary basis, during participation in an intensive therapeutic lifestyle medicine program, to help improve the compliance with healthy lifestyle changes for people with Type 2 diabetes (T2DM) and prediabetes (PD).
| Study group | Role | What they receive |
|---|---|---|
| Pilot | Experimental | Eligible subjects who have consented to the study, and have had the baseline data gathered as part of their participation in the Lifestyle Medicine Clinic, an intensive therapeutic lifestyle medicine program, will be given a CGMs device and supplies, and instructed in how to utilize these. They will set up the app on their smart phone to provide them with feedback on their glucose level to correlate with their lifestyle activities. Receives: Device: Temporary Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose profile
The blood glucose profile will be evaluated for out of range values
Measured: 12 weeks
Secondary outcomes (1)
participant survey
- Specifically concerning the Diabits software:
- What did you like about Diabits?
- What didn't you like about Diabits?
- Do you think Diabits has improved your blood sugar management?
- Did you complete the data entry most of the time? If not, please explain, and make suggestions on how the experience could be improved.
- Did you have any difficulty managing the sensor or device? If so, please explain, and make suggestions on how the experience could be improved.
- Overall, did you feel that the continuous glucose monitoring system was helpful? Please explain your answer. How was it helpful or unhelpful?
- What else should we know or would you like to tell us?
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Jan 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Why it stopped: Software company providing devices never responded. I believe they closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose ProfileStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot / feasibility study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Health System
- Responsible party
- Principal investigator, David Drozek, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306848
- Sponsor's protocol ID
- TBD-2
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2020
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: De-identified data will be posted after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporary Use of a Continuous Glucose Monitoring System as an Adjunct to Lifestyle Medicine Education for People With Type 2 Diabetes: a Feasibility Study.
- ClinicalTrials.gov ID
- NCT04306848
- Acronym / sponsor ID
- TBD-2
- Conditions
- Blood Glucose Profile
- Keywords
- continuous glucose monitoring, lifestyle medicine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Software company providing devices never responded. I believe they closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- Memorial Health System
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 13 Mar 2020 (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.
This is a feasibility study evaluating the potential to utilize a continuous glucose monitoring system (CGMs) on a temporary basis, during participation in a lifestyle medicine program, to help improve the compliance with healthy lifestyle changes for people with Type 2 diabetes (T2DM) and prediabetes (PD).
Detailed description
Glucose peaks after eating are an indication of the level of insulin resistance and the severity of disease in patients with T2DM. Many lifestyle factors affect the glucose elevation, including the glycemic index of food, timing of eating, physical activity, stress and sleep.
In practice, a glycemic profile, consisting of multiple glucose measurements before and after meals throughout the day, has sometimes been helpful in educating patients concerning the effects of their eating habits on blood sugar levels.
Would temporary use (8-10 weeks) of a continuous glucose monitoring system (CGMs) be a useful adjunct during lifestyle education in patients with T2DM or PD?
The purpose of this feasibility study is to evaluate the effectiveness of a CGMs on a small sample of patients while they are enrolled in a lifestyle medicine class, to:
- identify any logistical issue involved
- verify that useful data can be obtained for analysis
- inform development of a larger controlled study
Eligible subjects who have consented to the study, and have had the baseline data gathered as part of their participation in the Lifestyle Medicine Clinic, will be given a CGMs device and supplies, and instructed in how to utilize these. They will set up the app on their smart phone to provide them with feedback on their glucose level to correlate with their lifestyle activities.
The FDA approved CGMs utilizes a small filament-like probe that is entered into the skin and measures sugar levels of the interstitial fluid of the subcutaneous tissue. This correlates with blood glucose levels.
Daily, the subjects will enter data into their smart phone app, which will include:
- time of arising in the morning, and perceived quality of sleep
- time and description of food and beverages consumed
- time and description of physical activity
- time and description of stress management activities
- time and duration of naps
- bedtime
Once daily, the subject will complete a reflection entry in a diary on their glucose levels over the last 24 hours in relation to their logged lifestyle activities.
At the completion of the 8 sessions of The Lifestyle Medicine Clinic, participants will complete a survey asking open ended question concerning the use of the CGMs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot / feasibility study
| Arm | Type | Receives |
|---|---|---|
| Pilot | Experimental | Device: Temporary Continuous Glucose Monitoring SystemEligible subjects who have consented to the study, and have had the baseline data gathered as part of their participation in the Lifestyle Medicine Clinic, an intensive therapeutic lifestyle medicine program, will be given a CGMs device and supplies, and instructed in how to utilize these. They will set up the app on their smart phone to provide them with feedback on their glucose level to correlate with their lifestyle activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- be able to read and write English.
- be enrolled in The Lifestyle Medicine Clinic, taught by Dr. Drozek
- be diagnosed with type 2 diabetes (T2DM) or prediabetes (PDM)
- be at least 18 years of age
- be comfortable wearing a sensor continuously for up to 10 weeks
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Temporary Continuous Glucose Monitoring SystemAlso: Intensive therapeutic lifestyle medicineThis is a feasibility study evaluating the potential to utilize a continuous glucose monitoring system (CGMs) on a temporary basis, during participation in an intensive therapeutic lifestyle medicine program, to help improve the compliance with healthy lifestyle changes for people with Type 2 diabetes (T2DM) and prediabetes (PD). | Device | Pilot |
Primary outcome
Blood glucose profile
Time frame: 12 weeks
The blood glucose profile will be evaluated for out of range values
1 secondary outcome
participant survey
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Individual participant dataSharing planned: Undecided. De-identified data will be posted after completion of the study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary Continuous Glucose Monitoring System in people with Blood Glucose Profile, run by Ohio University 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 9 inclusion and 0 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: withdrawn, as of the sponsor's last update on 25 Mar 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Blood glucose profile (time frame: 12 weeks). 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 25 Mar 2022.