DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)NCT01614262
Examining The Role of CGM in T2DM
A study testing Continuous Glucose Monitoring with treatment algorithm in people with DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder), run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
Continuous glucose monitoring (CGM) technology has advanced the treatment of people with diabetes, however to date this technology had been primarily limited to use in patients treated with insulin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)
- What is being tested?
- Continuous Glucose Monitoring with treatment algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Sep 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject is eligible for the study if all of the following criteria are met:
- Provide written informed consent prior to enrollment
- Is male or female between 18-70 years old
- Has been treated by the Principal Investigator or referring physician in the same practice.
- Has Type 2 Diabetes Mellitus for greater than 12 months on 1-3 antihyperglycemic medications, on a stable dose for 90 days prior to screening.
- Has a HbA1c between 7.5-9.0% in the 90 days prior to screening.
- Currently performs self-monitoring blood glucose checks at least 3 times per week.
- Ability to adhere to protocol requirements.
Who cannot join
- 1. Has Type 1 Diabetes or Gestational Diabetes
- 2.Is pregnant or planning to become pregnant during the course of the study.
- 3.Current use of any insulin or history of insulin use in the last 6 months.
- 4.An acute coronary or cerebrovascular event in the previous 3 months.
- 5.Any planned surgery during the course of the study.
- 6.Current continuous renal replacement therapy.
Show all 10Show fewer
- 7.BMI ≥ 45 kg/m^2
- 8.Current oral or injectable steroid use.
- 9.Any previous history Continuous Glucose Monitoring use by any device or manufacturer.
- 10.Has a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta Diabetes Assoicates
Atlanta, Georgia, 30309
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Examining the Role of Continuous Glucose Monitoring (CGM) in Non-Insulin Treated Type 2 Diabetes
Continuous glucose monitoring (CGM) technology has advanced the treatment of people with diabetes, however to date this technology had been primarily limited to use in patients treated with insulin. CGM is a powerful tool that has the potential to enhance the care of patients treated with agents other than insulin; however this has not been tested. The purpose of this study is to determine whether improved glycemic control can be achieved through the use of intensive, periodic CGM monitoring in patients with T2DM treated with oral anti-hyperglycemic drugs (OADs). The data gathered from this pilot study will be utilized to determine if a larger, clinical effectiveness study to assess use of CGM to improve clinical outcomes in patients with T2DM treated with OADs is warranted.
Read the detailed description
The study will enroll and follow 90 participants for 187 days at two sites. Participants will be randomized (1:1 allocation ratio) to the CGM based intervention (Group 1) or the Self-Monitoring Blood Glucose (SMBG) based intervention (Group 2). Group 1 will receive care based upon the results of their CGM data while group 2 will receive care based upon traditional SMBG values. The clinical management algorithm will be utilized to guide the care of all subjects. All study participants will receive the iPro 2 devices (Medtronic Minimed, Northridge, CA 91325) to collect glucose measurements during five 1 week periods beginning on Day 0, Day 45, Day 90, Day 135 and Day 180. Laboratory measures of glucose control (HbA1c and FPG) and quality of life outcomes will be evaluated at Day 0, Day 90 and Day 187.
The iPro2 device is FDA approved for sale in the US and is a commercial product. The iPro2 digital recorder is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. The iPro 2 is intended to be worn for intermittent periods to uncover glycemic variability and patterns. The data obtained can then be used to maximum treatment strategies to improve patient outcomes. The advantage to the iPro 2 is that it is blinded and will not be influenced by the patient.
The Enlite sensor, is an investigational device, is a 6 day sensor. The subjects in this study will wear the Enlite sensor for a 6 day monitoring period. The Enlite sensor is CE-marked and available for sale in over 50 countries and is currently seeking FDA approval.
CareLink iPro Clinical Therapy Management Software is part of the iPro2 CGM system. The Carelink iPro Clinical Software is intended to support clinical trials. This internet based software allows data to be viewed and easily evaluated by physicians. A PC links to Carelink iPro Clinical via the Internet and allows the user to upload data from Medtronic Diabetes iPro2 devices. Because the algorithm proposed in this protocol has been programed into the Software, this is an (IDE-exempt) investigational device.
Adult individuals 18-70 years of age, diagnosed with T2DM who are currently being treated in the Principal Investigators or referring physicians practice with a HbA1c between 7.5-9.0%.
- Being tested
- Continuous Glucose Monitoring with treatment algorithm
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring with treatment algorithmOther
those subjects randomized to Continuous Glucose Monitoring results will be placed in CareLink iPro Clinical Management system, the experimental treatment guideline/algorithm has been programmed into the system. Providers will make treatment decisions based off of results of CGM.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitoring | Experimental | The Continuous Glucose Monitoring (CGM) arm will receive care based upon results from there CGM data; treatment decisions are based on algorithm and CGM data Receives: Other: Continuous Glucose Monitoring with treatment algorithm |
| Self Monitoring Blood Glucose | Active comparator | Subjects in the Self Monitoring Blood Glucose group will have treatment decisions based on self monitored blood glucose values and not CGM values, per current standard of care. Receives: Other: Continuous Glucose Monitoring with treatment algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in glycosylated hemoglobin using intensive periodic CGM monitoring vs traditional monitoring
Measured: baseline and day 187
Secondary outcomes (3)
change in fasting plasma glucose between two groups
Measured: baseline and day 187
comparison of change of the area under the curve for CGM results for both treatment arms
Measured: baseline and day 187
quality of life data evaluation
Provide preliminary data on the effect of CGM monitoring on subjects' quality of life.
Measured: baseline and day 187
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)Studies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Atlanta Diabetes Associates, UNC Coordinating Center
- Responsible party
- Sponsor
- Investigators
- John B Buse, MD, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614262
- Sponsor's protocol ID
- 12-0899
- Status last verified
- Jul 2015
- First submitted
- 5 Jun 2012
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Role of Continuous Glucose Monitoring (CGM) in Non-Insulin Treated Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01614262
- Acronym / sponsor ID
- 12-0899
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Medtronic, Atlanta Diabetes Associates, UNC Coordinating Center
- Study start
- Jun 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 Jun 2012 (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.
Continuous glucose monitoring (CGM) technology has advanced the treatment of people with diabetes, however to date this technology had been primarily limited to use in patients treated with insulin. CGM is a powerful tool that has the potential to enhance the care of patients treated with agents other than insulin; however this has not been tested. The purpose of this study is to determine whether improved glycemic control can be achieved through the use of intensive, periodic CGM monitoring in patients with T2DM treated with oral anti-hyperglycemic drugs (OADs). The data gathered from this pilot study will be utilized to determine if a larger, clinical effectiveness study to assess use of CGM to improve clinical outcomes in patients with T2DM treated with OADs is warranted.
Detailed description
The study will enroll and follow 90 participants for 187 days at two sites. Participants will be randomized (1:1 allocation ratio) to the CGM based intervention (Group 1) or the Self-Monitoring Blood Glucose (SMBG) based intervention (Group 2). Group 1 will receive care based upon the results of their CGM data while group 2 will receive care based upon traditional SMBG values. The clinical management algorithm will be utilized to guide the care of all subjects. All study participants will receive the iPro 2 devices (Medtronic Minimed, Northridge, CA 91325) to collect glucose measurements during five 1 week periods beginning on Day 0, Day 45, Day 90, Day 135 and Day 180. Laboratory measures of glucose control (HbA1c and FPG) and quality of life outcomes will be evaluated at Day 0, Day 90 and Day 187.
The iPro2 device is FDA approved for sale in the US and is a commercial product. The iPro2 digital recorder is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. The iPro 2 is intended to be worn for intermittent periods to uncover glycemic variability and patterns. The data obtained can then be used to maximum treatment strategies to improve patient outcomes. The advantage to the iPro 2 is that it is blinded and will not be influenced by the patient.
The Enlite sensor, is an investigational device, is a 6 day sensor. The subjects in this study will wear the Enlite sensor for a 6 day monitoring period. The Enlite sensor is CE-marked and available for sale in over 50 countries and is currently seeking FDA approval.
CareLink iPro Clinical Therapy Management Software is part of the iPro2 CGM system. The Carelink iPro Clinical Software is intended to support clinical trials. This internet based software allows data to be viewed and easily evaluated by physicians. A PC links to Carelink iPro Clinical via the Internet and allows the user to upload data from Medtronic Diabetes iPro2 devices. Because the algorithm proposed in this protocol has been programed into the Software, this is an (IDE-exempt) investigational device.
Adult individuals 18-70 years of age, diagnosed with T2DM who are currently being treated in the Principal Investigators or referring physicians practice with a HbA1c between 7.5-9.0%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitoring | Experimental | Other: Continuous Glucose Monitoring with treatment algorithmThe Continuous Glucose Monitoring (CGM) arm will receive care based upon results from there CGM data; treatment decisions are based on algorithm and CGM data |
| Self Monitoring Blood Glucose | Active comparator | Other: Continuous Glucose Monitoring with treatment algorithmSubjects in the Self Monitoring Blood Glucose group will have treatment decisions based on self monitored blood glucose values and not CGM values, per current standard of care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A subject is eligible for the study if all of the following criteria are met:
Key exclusion criteria (10 listed)
- 1. Has Type 1 Diabetes or Gestational Diabetes
- 2.Is pregnant or planning to become pregnant during the course of the study.
- 3.Current use of any insulin or history of insulin use in the last 6 months.
- 4.An acute coronary or cerebrovascular event in the previous 3 months.
- 5.Any planned surgery during the course of the study.
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 Monitoring with treatment algorithmthose subjects randomized to Continuous Glucose Monitoring results will be placed in CareLink iPro Clinical Management system, the experimental treatment guideline/algorithm has been programmed into the system. Providers will make treatment decisions based off of results of CGM. | Other | Continuous Glucose Monitoring, Self Monitoring Blood Glucose |
Primary outcome
change in glycosylated hemoglobin using intensive periodic CGM monitoring vs traditional monitoring
Time frame: baseline and day 187
3 secondary outcomes
change in fasting plasma glucose between two groups
Time frame: baseline and day 187
comparison of change of the area under the curve for CGM results for both treatment arms
Time frame: baseline and day 187
quality of life data evaluation
Time frame: baseline and day 187
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 19 Apr 2017.
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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.
John B Buse, MD, PhD principal investigator
University of North Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring with treatment algorithm in people with DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder), run by University of North Carolina, Chapel Hill at 2 sites 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 8 inclusion and 10 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 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
change in glycosylated hemoglobin using intensive periodic CGM monitoring vs traditional monitoring (time frame: baseline and day 187). 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 19 Apr 2017.