Type 2 DiabetesNCT02293577
Continuous Glucose Monitoring in Youth With Type 2 Diabetes
An observational study of Type 2 Diabetes, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to use a continuous glucose monitor (CGM) to describe the day to day blood glucose variability in youth with type 2 diabetes. The hypothesis is that CGM will identify caloric and exercise related variation in blood glucose that is not identified by the subjects' current regimen of… Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- continuous glucose monitor
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Nov 2015
- Phase
- Observational
- 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 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Youth with type 2 diabetes will be recruited from the type 2 diabetes clinic.
Who may be able to join
- Clinical diagnosis of type 2 diabetes
- Duration of type 2 diabetes ≥ 3 months
- Naïve to continuous glucose monitoring
- Willing to wear a continuous glucose monitor for 5 days
- Willing to check blood sugar at least every 12 hours, preferably 3 times a day
- Willing to wear an accelerometer for 5 days
Show all 10Show fewer
- Willing to keep a food record for 5 days, including frequent phone contact from the research staff
- Be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety
- Able to give informed consent (for children <18 years, permission from parents and subject assent will be required)
- Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods
Who cannot join
- Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
- Use of any medications (besides insulin and/or metformin) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy
- Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
- History of hypoglycemic seizure within last year or frequent hypoglycemia (≥2 time a month)
- Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Pediatric Diabetes Research Program
New Haven, Connecticut, 06511
About this study
The purpose of this study is to use a continuous glucose monitor (CGM) to describe the day to day blood glucose variability in youth with type 2 diabetes. The hypothesis is that CGM will identify caloric and exercise related variation in blood glucose that is not identified by the subjects' current regimen of intermittent finger stick blood glucose measurements.
Read the detailed description
The TODAY study and other studies have reported disappointing results of intensive life-style programs alone or in combination with metformin in maintaining optimal control of type 2 diabetes (T2D) in adolescents. Continuous glucose monitoring (CGM) has been successful in lifestyle modification in adults with T2D but use of CGM has not been studied in youth with T2D. Thus the feasibility of this technology should be evaluated in this patient population as it may prove to be an effective adjunct to treatment in the future.
Youth with type 2 diabetes will be approached for enrollment in this study. The study will be explained to volunteers who meet eligibility criteria and informed consent/assent will be obtained. Demographic data will be recorded. A medical history will be performed. A urine pregnancy test (in women) will be measured to confirm eligibility. Height, weight, BMI, percent body fat, fat mass, and fat free mass will be measured. Hemoglobin A1c (HbA1c) will be measured. After enrollment a blinded CGM will be placed. CGM is a device inserted under the skin on the abdomen which monitors glucose levels every 5 minutes, recording this information. CGM is commonly worn by kids with type 1 diabetes. The study will allow collection of information on glucose variability in much greater detail than can be seen from intermittent fingerstick glucose values or from an oral glucose tolerance test. Subjects will meet with a nutritionist to learn how to keep a food record. They will be given empty food records to complete for each day. They will also be given an accelerometer and instructed in its use, however they will remain blinded to the data obtained. The study will be 5 days in length. Subjects will be urged to continue their normal eating and activity behaviors. During the study period blood sugar and CGM data will be recorded via glucometer and sensor downloads, dietary intake via food record, and activity via accelerometer. Glucometer testing of blood glucose is required at least every 12 hours to calibrate the CGM. To minimize the need for overnight tests to calibrate the CGM, subjects will be asked to check their blood sugar using a glucometer 3 times a day, preferably fasting in the morning before breakfast, before dinner, and at bedtime. To optimize the accuracy of dietary intake records, subjects will be contacted frequently and the food record information recorded by study personnel. Subjects will be given a "morning checklist" to keep in a visible area to improve compliance by reminding them to keep study devices with them all day. At the follow-up visit the CGM will be downloaded revealing blood glucose tracings for the study period. Additionally the completed food records will be collected and the accelerometer will be downloaded.
- Conditions
- Type 2 Diabetes
- Being tested
- continuous glucose monitor
- 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.
continuous glucose monitorDevice
In this study all subjects will wear a continuous glucose monitor for 5 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time with blood glucose >140 mg/dL
Subjects will be assessed for average amount of time spent with blood sugar >140, >200, and >300 mg/dL across the 5 day study period.
Measured: 5 days
Glycemic excursion after caloric intake
Glycemic excursion after caloric intake will be assessed using the mean change (delta) blood glucose meal time to 2-4 hours afterwards over the 5 day study period.
Measured: 5 days
Glucose area under the curve
Continuous Glucose Monitoring (CGM) glucose readings will be averaged across the 5 day period and used to obtain the area under the curve.
Measured: 5 days
Average glucose
Continuous Glucose Monitoring (CGM) glucose readings will be used to obtain the average glucose levels for subjects across the 5 day period.
Measured: 5 days
Peak glucose
Continuous Glucose Monitoring (CGM) glucose readings will be used to obtain the peak glucose level for subjects over the 5 day period.
Measured: 5 days
Time with blood glucose >200 mg/dL
Subjects will be assessed for average amount of time spent with blood sugar >140, >200, and >300 mg/dL across the 5 day study period.
Measured: 5 days
Time with blood glucose >300 mg/dL
Subjects will be assessed for average amount of time spent with blood sugar >140, >200, and >300 mg/dL across the 5 day study period.
Measured: 5 days
Secondary outcomes (5)
Caloric intake
Food diaries will be used to quantify and assess the average daily caloric intake of subjects across the 5 day study period.
Measured: 5 days
Total fat intake
Food diaries will be used to quantify and assess the average daily caloric intake of subjects across the 5 day study period. The percent kcal from total fat will be obtained from these data.
Measured: 5 days
Sugar intake
Food diaries will be used to quantify and assess the average daily caloric intake of subjects across the 5 day study period. The percent kcal from sugar will be obtained from these data.
Measured: 5 days
Protein intake
Food diaries will be used to quantify and assess the average daily caloric intake of subjects across the 5 day study period. The percent kcal from protein will be obtained from these data.
Measured: 5 days
Physical Activity
Subjects will have their average daily physical activity measured via accelerometer. The average number of "steps" is the outcome of interest.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Van Name, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293577
- Sponsor's protocol ID
- HIC# 1409014566
- Other IDs
- K12DK094714
- Status last verified
- Mar 2020
- First submitted
- 7 Nov 2014
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in Youth With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02293577
- Acronym / sponsor ID
- HIC# 1409014566
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Nov 2014 (estimated)
- 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.
The purpose of this study is to use a continuous glucose monitor (CGM) to describe the day to day blood glucose variability in youth with type 2 diabetes. The hypothesis is that CGM will identify caloric and exercise related variation in blood glucose that is not identified by the subjects' current regimen of intermittent finger stick blood glucose measurements.
Detailed description
The TODAY study and other studies have reported disappointing results of intensive life-style programs alone or in combination with metformin in maintaining optimal control of type 2 diabetes (T2D) in adolescents. Continuous glucose monitoring (CGM) has been successful in lifestyle modification in adults with T2D but use of CGM has not been studied in youth with T2D. Thus the feasibility of this technology should be evaluated in this patient population as it may prove to be an effective adjunct to treatment in the future.
Youth with type 2 diabetes will be approached for enrollment in this study. The study will be explained to volunteers who meet eligibility criteria and informed consent/assent will be obtained. Demographic data will be recorded. A medical history will be performed. A urine pregnancy test (in women) will be measured to confirm eligibility. Height, weight, BMI, percent body fat, fat mass, and fat free mass will be measured. Hemoglobin A1c (HbA1c) will be measured. After enrollment a blinded CGM will be placed. CGM is a device inserted under the skin on the abdomen which monitors glucose levels every 5 minutes, recording this information. CGM is commonly worn by kids with type 1 diabetes. The study will allow collection of information on glucose variability in much greater detail than can be seen from intermittent fingerstick glucose values or from an oral glucose tolerance test. Subjects will meet with a nutritionist to learn how to keep a food record. They will be given empty food records to complete for each day. They will also be given an accelerometer and instructed in its use, however they will remain blinded to the data obtained. The study will be 5 days in length. Subjects will be urged to continue their normal eating and activity behaviors. During the study period blood sugar and CGM data will be recorded via glucometer and sensor downloads, dietary intake via food record, and activity via accelerometer. Glucometer testing of blood glucose is required at least every 12 hours to calibrate the CGM. To minimize the need for overnight tests to calibrate the CGM, subjects will be asked to check their blood sugar using a glucometer 3 times a day, preferably fasting in the morning before breakfast, before dinner, and at bedtime. To optimize the accuracy of dietary intake records, subjects will be contacted frequently and the food record information recorded by study personnel. Subjects will be given a "morning checklist" to keep in a visible area to improve compliance by reminding them to keep study devices with them all day. At the follow-up visit the CGM will be downloaded revealing blood glucose tracings for the study period. Additionally the completed food records will be collected and the accelerometer will be downloaded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Youth with type 2 diabetes will be recruited from the type 2 diabetes clinic.
Key inclusion criteria (10 listed)
- Clinical diagnosis of type 2 diabetes
- Duration of type 2 diabetes ≥ 3 months
- Naïve to continuous glucose monitoring
- Willing to wear a continuous glucose monitor for 5 days
- Willing to check blood sugar at least every 12 hours, preferably 3 times a day
Key exclusion criteria (5 listed)
- Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
- Use of any medications (besides insulin and/or metformin) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy
- Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
- History of hypoglycemic seizure within last year or frequent hypoglycemia (≥2 time a month)
- Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
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 |
|---|---|---|
| continuous glucose monitorIn this study all subjects will wear a continuous glucose monitor for 5 days. | Device | – |
Primary outcome
Time with blood glucose >140 mg/dL
Time frame: 5 days
Subjects will be assessed for average amount of time spent with blood sugar >140, >200, and >300 mg/dL across the 5 day study period.
Glycemic excursion after caloric intake
Time frame: 5 days
Glycemic excursion after caloric intake will be assessed using the mean change (delta) blood glucose meal time to 2-4 hours afterwards over the 5 day study period.
Glucose area under the curve
Time frame: 5 days
Continuous Glucose Monitoring (CGM) glucose readings will be averaged across the 5 day period and used to obtain the area under the curve.
Average glucose
Time frame: 5 days
Continuous Glucose Monitoring (CGM) glucose readings will be used to obtain the average glucose levels for subjects across the 5 day period.
Peak glucose
Time frame: 5 days
Continuous Glucose Monitoring (CGM) glucose readings will be used to obtain the peak glucose level for subjects over the 5 day period.
Time with blood glucose >200 mg/dL
Time frame: 5 days
Subjects will be assessed for average amount of time spent with blood sugar >140, >200, and >300 mg/dL across the 5 day study period.
Time with blood glucose >300 mg/dL
Time frame: 5 days
Subjects will be assessed for average amount of time spent with blood sugar >140, >200, and >300 mg/dL across the 5 day study period.
5 secondary outcomes
Caloric intake
Time frame: 5 days
Total fat intake
Time frame: 5 days
Sugar intake
Time frame: 5 days
Protein intake
Time frame: 5 days
Physical Activity
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
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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.
Michelle Van Name principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Yale 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 6 Mar 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time with blood glucose >140 mg/dL (time frame: 5 days). The study lists 7 primary outcomes in all. 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 6 Mar 2020.