Diabetes Mellitus, Type 2NCT02432391
Lifestyle Modification for Type 2 Diabetes Involving Reduction of After-meal Blood Glucose Elevations
A study testing GEM in people with Diabetes Mellitus, Type 2, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to determine if a lifestyle modification program (GEM) that focuses on reducing after-meal blood glucose elevations can improve blood glucose control in people with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 24 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GEM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jan 2015
- 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 24 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes within the past 5 years
- Age >24 and <80 years
- HbA1c >7.0%
- Approval of primary care physician to participate
Who cannot join
- Currently using, or used within the last 3 months, medications that directly lower BG (e.g., insulin, sulfonylureas, glinides, or DPP-4 inhibitors).
- Currently using, or used within the last 3 months, thiazides at doses above HCTZ 25 mg or equivalent, or loop diuretics above furosemide 20mg or equivalent.
- Currently pregnant or contemplating pregnancy in the coming year
- Currently using, or used within the last 3 months, medications that impede weight loss (e.g., prednisone)
- Having conditions that preclude increasing physical activity, e.g. severe neuropathy, active cardiovascular disease, emphysema, osteoarthritis, stroke.
- Undergoing cancer treatment
- History of lactic acidosis
- Diagnosed with renal impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Self-Monitoring of Blood Glucose (SMBG) as an Educational Tool and a Negative Feedback Loop to Reinforce Blood Glucose Lowering and Discourage Blood Glucose Elevating Self-Management Behaviors in Adults With T2DM
The purpose of this study is to determine if a lifestyle modification program (GEM) that focuses on reducing after-meal blood glucose elevations can improve blood glucose control in people with type 2 diabetes. Half of the participants will continue their routine medical care, and half will receive five sessions of GEM in addition to their routine care. The two groups will be assessed using diabetes-relevant medical, behavioral and psychological measures.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GEM
- 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.
GEMBehavioural
GEM is an integrated lifestyle modification program that focuses on reducing postprandial blood glucose through replacing high with low glycemic load foods and increasing routine physical activity guided by systematic blood glucose monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | No intervention | Participants continue their routine medical care for type 2 diabetes |
| GEM | Experimental | Participants receive the GEM (Glycemic load, Exercise, and Monitoring blood glucose) lifestyle modification program and continue their routine medical care for type 2 diabetes. Receives: Behavioral: GEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline glycosylated hemoglobin at 6 months
HbA1c
Measured: 0 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startMay 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- LifeScan
- Responsible party
- Principal investigator, Daniel Cox, PhD, University of Virginia
- Investigators
- Daniel Cox, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432391
- Sponsor's protocol ID
- 16293
- Status last verified
- Apr 2015
- First submitted
- 24 Apr 2015
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cox DJ, Fang K, McCall AL, Conaway MR, Banton TA, Moncrief MA, Diamond AM, Taylor AG. Behavioral Strategies to Lower Postprandial Glucose in Those with Type 2 Diabetes May Also Lower Risk of Coronary Heart Disease. Diabetes Ther. 2019 Feb;10(1):277-281. doi: 10.1007/s13300-018-0554-6. Epub 2018 Dec 18.
PubMed 30565055
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Monitoring of Blood Glucose (SMBG) as an Educational Tool and a Negative Feedback Loop to Reinforce Blood Glucose Lowering and Discourage Blood Glucose Elevating Self-Management Behaviors in Adults With T2DM
- ClinicalTrials.gov ID
- NCT02432391
- Acronym / sponsor ID
- 16293
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- LifeScan
- Study start
- May 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 4 May 2015 (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 determine if a lifestyle modification program (GEM) that focuses on reducing after-meal blood glucose elevations can improve blood glucose control in people with type 2 diabetes. Half of the participants will continue their routine medical care, and half will receive five sessions of GEM in addition to their routine care. The two groups will be assessed using diabetes-relevant medical, behavioral and psychological measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care | No intervention | –Participants continue their routine medical care for type 2 diabetes |
| GEM | Experimental | Behavioral: GEMParticipants receive the GEM (Glycemic load, Exercise, and Monitoring blood glucose) lifestyle modification program and continue their routine medical care for type 2 diabetes. |
Who may qualify
- Ages
- 24 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with type 2 diabetes within the past 5 years
- Age >24 and <80 years
- HbA1c >7.0%
- Approval of primary care physician to participate
Key exclusion criteria (8 listed)
- Currently using, or used within the last 3 months, medications that directly lower BG (e.g., insulin, sulfonylureas, glinides, or DPP-4 inhibitors).
- Currently using, or used within the last 3 months, thiazides at doses above HCTZ 25 mg or equivalent, or loop diuretics above furosemide 20mg or equivalent.
- Currently pregnant or contemplating pregnancy in the coming year
- Currently using, or used within the last 3 months, medications that impede weight loss (e.g., prednisone)
- Having conditions that preclude increasing physical activity, e.g. severe neuropathy, active cardiovascular disease, emphysema, osteoarthritis, stroke.
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 |
|---|---|---|
| GEMGEM is an integrated lifestyle modification program that focuses on reducing postprandial blood glucose through replacing high with low glycemic load foods and increasing routine physical activity guided by systematic blood glucose monitoring. | Behavioural | GEM |
Primary outcome
Change from baseline glycosylated hemoglobin at 6 months
Time frame: 0 and 6 months
HbA1c
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 4 May 2015.
- Derived from this study: PubMed 30565055Cox DJ, Fang K, McCall AL, Conaway MR, Banton TA, Moncrief MA, Diamond AM, Taylor AG. Behavioral Strategies to Lower Postprandial Glucose in Those with Type 2 Diabetes May Also Lower Risk of Coronary Heart Disease. Diabetes Ther. 2019 Feb;10(1):277-281. doi: 10.1007/s13300-018-0554-6. Epub 2018 Dec 18.
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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.
Daniel Cox, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GEM in people with Diabetes Mellitus, Type 2, run by University of Virginia 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 4 inclusion and 8 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 4 May 2015. 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?
Change from baseline glycosylated hemoglobin at 6 months (time frame: 0 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02432391, which also lists 1 linked publication.
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 4 May 2015.