Diabetes Mellitus Type 2Phase 4CGMNCT00529815
Continuous Glucose Monitoring in Patients With Type 2 Diabetes
A Phase 4 study testing Continuous Glucose Monitor and Glucometer in people with Diabetes Mellitus Type 2, run by Walter Reed Army Medical Center at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine if a Real-Time Continuous Glucose Monitoring System (CGMS) is a more effective method of improving glycemic control in patients with type 2 diabetes than is episodic self blood glucose monitoring(SBGM) in the both the short- and long-term. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Continuous Glucose Monitor and Glucometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2010
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older.
- Known Type 2 diabetes for at least 3 months
- Diet controlled, on oral therapy, on basal insulin (e.g. glargine), or on oral therapy and a basal insulin
- A1C levels between 7% and 12%.
- Able to independently measure and read finger stick blood glucose levels with the Accu-chek Aviva glucometer and the DexCom Continuous Glucose Monitoring device (DexCom DTS-7).
- Subjects will have attended a American Diabetes Association recognized Diabetes Self-Management Education (DSME) program at one of the WRHCS military treatment facilities (MTFs) within the past five years.
- Willing to avoid or minimize use of acetaminophen (Tylenol) and all acetaminophen- containing products such as most over-the-counter (OTC) medications during the study period (Appendix 5)..
Who cannot join
- Female subjects who are pregnant, lactating, planning to become pregnant, or without a safe contraceptive method.
- A1C levels are less than 7 or greater than 12.
- Subjects who are taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Hospital Center
Washington D.C., District of Columbia, 20307
About this study
Official title: A Pilot Study to Determine the Impact of Real-Time Continuous Glucose Monitoring (CGM) on Patients With Type 2 Diabetes
The purpose of this pilot study is to determine if a Real-Time Continuous Glucose Monitoring System (CGMS) is a more effective method of improving glycemic control in patients with type 2 diabetes than is episodic self blood glucose monitoring(SBGM) in the both the short- and long-term. CGMS, which includes a sensor that can be self- inserted under the skin and a discrete monitor that records and displays blood sugar levels nearly continuously, allows for real time blood glucose monitoring. This will be a prospective, randomized control trial comparing participants with type II diabetes use of CGMS versus SBGM. The primary endpoint will be improvement of glycemic control as measured by glycosylated hemoglobin (A1C). The secondary endpoints will compare mean daily glucose levels, the number of both hypoglycemic and hyperglycemic events, the amount of time spent in target blood glucose, and the perceived level of diabetes-related stress between the two groups. Participants will be randomized to either the control (SBGM) or intervention (CGMS) group. Subjects in the intervention group will alternate the use of the CGMS with episodic self blood glucose monitoring for four cycles of two weeks during the 12 week study. The control group will perform episodic SBGM throughout the study. The intensified monitoring schedules for both groups will end at the end of week 12, but glycemic control measurement by A1C will continue through 52 weeks. A1C levels will be drawn at 0, 12, 24, 38, and 52 weeks. Mean daily blood glucose levels, number of hypo and hyperglycemic events, and duration of time spent in target blood glucose range will be downloaded from patients' meters periodically throughout the study. The SF-8, a general quality of life questionnaire for people with chronic disease, and Problem Areas in Diabetes (PAID), a diabetes-related quality of life questionnaire, will be completed at the beginning and end of the study. The results of this study may help highlight which blood glucose monitoring methods are most likely to improve patients' ability to achieve and maintain target levels of glycemic control.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Continuous Glucose Monitor, Glucometer
- Keywords
- Continuous, blood, glucose, monitoring, diabetes, type2
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitorDevice
The intervention group will alternate the use of the CGM with episodic self blood glucose monitoring for four cycles of two weeks using the CGM and episodic SBGM and one week only using episodic SBGM during the 12 week study.
GlucometerDevice
The control group (SBGM) will be instructed in the use of the Accuchek Aviva glucometer.
| Study group | Role | What they receive |
|---|---|---|
| 1CGM and SBGM | Experimental | Intervention group will alternate the use of the CGM with episodic self blood glucose monitoring for four cycles of two weeks using the CGM and episodic SBGM and one week only using episodic SBGM during the 12 week study. Receives: Device: Continuous Glucose Monitor |
| 2 SBGM | Active comparator | The control group (SBGM) will be instructed in the use of the Accuchek Aviva glucometer. Receives: Device: Glucometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study will determine if a real-time continuous glucose monitoring system is a more effective method of improving glycemic control in patients with type 2 diabetes than is episodic self blood glucose monitoring in the both the short- and long-term.
Measured: March 1, 2010
Secondary outcomes (1)
The results of this study could also provide information on the impact of the two methods of glycemic monitoring on number of hypoglycemic and hyperglycemic events, and quality of life.
Measured: March 1, 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2010 (estimated)
- Study completionSep 2010 (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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Robert A Vigersky, MD, Principal investigator, WRAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529815
- Sponsor's protocol ID
- WU # 07-13023
- Acronym
- CGM
- Status last verified
- Jun 2009
- First submitted
- 13 Sep 2007
- Last updated
- 25 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Impact of Real-Time Continuous Glucose Monitoring (CGM) on Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00529815
- Acronym / sponsor ID
- CGM / WU # 07-13023
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Continuous, blood, glucose, monitoring, diabetes, type2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- Sep 2007
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 14 Sep 2007 (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 pilot study is to determine if a Real-Time Continuous Glucose Monitoring System (CGMS) is a more effective method of improving glycemic control in patients with type 2 diabetes than is episodic self blood glucose monitoring(SBGM) in the both the short- and long-term. CGMS, which includes a sensor that can be self- inserted under the skin and a discrete monitor that records and displays blood sugar levels nearly continuously, allows for real time blood glucose monitoring. This will be a prospective, randomized control trial comparing participants with type II diabetes use of CGMS versus SBGM. The primary endpoint will be improvement of glycemic control as measured by glycosylated hemoglobin (A1C). The secondary endpoints will compare mean daily glucose levels, the number of both hypoglycemic and hyperglycemic events, the amount of time spent in target blood glucose, and the perceived level of diabetes-related stress between the two groups. Participants will be randomized to either the control (SBGM) or intervention (CGMS) group. Subjects in the intervention group will alternate the use of the CGMS with episodic self blood glucose monitoring for four cycles of two weeks during the 12 week study. The control group will perform episodic SBGM throughout the study. The intensified monitoring schedules for both groups will end at the end of week 12, but glycemic control measurement by A1C will continue through 52 weeks. A1C levels will be drawn at 0, 12, 24, 38, and 52 weeks. Mean daily blood glucose levels, number of hypo and hyperglycemic events, and duration of time spent in target blood glucose range will be downloaded from patients' meters periodically throughout the study. The SF-8, a general quality of life questionnaire for people with chronic disease, and Problem Areas in Diabetes (PAID), a diabetes-related quality of life questionnaire, will be completed at the beginning and end of the study. The results of this study may help highlight which blood glucose monitoring methods are most likely to improve patients' ability to achieve and maintain target levels of glycemic control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1CGM and SBGM | Experimental | Device: Continuous Glucose MonitorIntervention group will alternate the use of the CGM with episodic self blood glucose monitoring for four cycles of two weeks using the CGM and episodic SBGM and one week only using episodic SBGM during the 12 week study. |
| 2 SBGM | Active comparator | Device: GlucometerThe control group (SBGM) will be instructed in the use of the Accuchek Aviva glucometer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 or older.
- Known Type 2 diabetes for at least 3 months
- Diet controlled, on oral therapy, on basal insulin (e.g. glargine), or on oral therapy and a basal insulin
- A1C levels between 7% and 12%.
- Able to independently measure and read finger stick blood glucose levels with the Accu-chek Aviva glucometer and the DexCom Continuous Glucose Monitoring device (DexCom DTS-7).
Key exclusion criteria (3 listed)
- Female subjects who are pregnant, lactating, planning to become pregnant, or without a safe contraceptive method.
- A1C levels are less than 7 or greater than 12.
- Subjects who are taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents 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 MonitorThe intervention group will alternate the use of the CGM with episodic self blood glucose monitoring for four cycles of two weeks using the CGM and episodic SBGM and one week only using episodic SBGM during the 12 week study. | Device | 1CGM and SBGM |
| GlucometerThe control group (SBGM) will be instructed in the use of the Accuchek Aviva glucometer. | Device | 2 SBGM |
Primary outcome
This study will determine if a real-time continuous glucose monitoring system is a more effective method of improving glycemic control in patients with type 2 diabetes than is episodic self blood glucose monitoring in the both the short- and long-term.
Time frame: March 1, 2010
1 secondary outcome
The results of this study could also provide information on the impact of the two methods of glycemic monitoring on number of hypoglycemic and hyperglycemic events, and quality of life.
Time frame: March 1, 2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2010.
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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.
Robert A Vigersky, MD principal investigator
WRAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous Glucose Monitor and Glucometer in people with Diabetes Mellitus Type 2, run by Walter Reed Army Medical Center 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Feb 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
This study will determine if a real-time continuous glucose monitoring system is a more effective method of improving glycemic control in patients with type 2 diabetes than is episodic self blood glucose monitoring in the both the short- and long-term. (time frame: March 1, 2010). 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 Feb 2010.