Type 2 DiabetesPhase 4NCT00202033
Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes
A Phase 4 study testing frequency of self monitoring blood glucose in people with Type 2 Diabetes, run by HealthPartners Institute at 1 site in United States.
Trial summary
To determine if the frequency of blood glucose testing in patients with type 2 diabetes who are being treated with diet and exercise alone or diet and exercise plus oral agents will impact the HbA1c level. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- frequency of self monitoring blood glucose
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to May 2009
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Treatment with diet and exercise alone or with the addition of 1 or 2 oral agents
- Enrolled in Type 2 BASICS program
- A1c between 7.0 and 11%, inclusive
- Able to understand spoken English
Who cannot join
- Insulin therapy
- Unable/unwilling to perform SMBG
- Participating in another research study
- Currently performing SMBG >3 times/week
Trial locations and contacts
1 site in 1 country.
United States1 site
International Diabetes Center
Minneapolis, Minnesota, 55416
About this study
To determine if the frequency of blood glucose testing in patients with type 2 diabetes who are being treated with diet and exercise alone or diet and exercise plus oral agents will impact the HbA1c level.
Read the detailed description
To determine the impact of SMBG frequency on blood glucose control in patients receiving systematic diabetes management education through Type 2 Diabetes BASICS at International Diabetes Center.
- Conditions
- Type 2 Diabetes
- Being tested
- frequency of self monitoring blood glucose
- Keywords
- referred to, comprehensive, diabetes, education, program
- 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.
frequency of self monitoring blood glucoseBehavioural
Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | self monitor blood glucose 3 times a day per usual diabetes class curriculum Receives: Behavioral: frequency of self monitoring blood glucose |
| 2 | Experimental | only self monitor blood glucose when fasting Receives: Behavioral: frequency of self monitoring blood glucose |
| 3 | Experimental | no self monitoring of blood glucose Receives: Behavioral: frequency of self monitoring blood glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 2 years
Secondary outcomes (1)
blood glucose testing frequency
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionMay 2009
- Study completionMay 2009
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- International Diabetes Center at Park Nicollet, LifeScan
- Responsible party
- Sponsor
- Investigators
- Richard M Bergenstal, MD, Principal investigator, Park Nicollet Institute/International Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202033
- Sponsor's protocol ID
- 01856-04-C
- Status last verified
- Apr 2013
- First submitted
- 12 Sep 2005
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00202033
- Acronym / sponsor ID
- 01856-04-C
- Conditions
- Type 2 Diabetes
- Keywords
- referred to, comprehensive, diabetes, education, program
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- International Diabetes Center at Park Nicollet, LifeScan
- Study start
- Sep 2004
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 Sep 2005 (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.
To determine if the frequency of blood glucose testing in patients with type 2 diabetes who are being treated with diet and exercise alone or diet and exercise plus oral agents will impact the HbA1c level.
Detailed description
To determine the impact of SMBG frequency on blood glucose control in patients receiving systematic diabetes management education through Type 2 Diabetes BASICS at International Diabetes Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: frequency of self monitoring blood glucoseself monitor blood glucose 3 times a day per usual diabetes class curriculum |
| 2 | Experimental | Behavioral: frequency of self monitoring blood glucoseonly self monitor blood glucose when fasting |
| 3 | Experimental | Behavioral: frequency of self monitoring blood glucoseno self monitoring of blood glucose |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes
- Treatment with diet and exercise alone or with the addition of 1 or 2 oral agents
- Enrolled in Type 2 BASICS program
- A1c between 7.0 and 11%, inclusive
- Able to understand spoken English
Key exclusion criteria (4 listed)
- Insulin therapy
- Unable/unwilling to perform SMBG
- Participating in another research study
- Currently performing SMBG >3 times/week
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 |
|---|---|---|
| frequency of self monitoring blood glucoseEvaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes. | Behavioural | 1, 2, 3 |
Primary outcome
HbA1c
Time frame: 2 years
1 secondary outcome
blood glucose testing frequency
Time frame: 2 years
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 3 Dec 2015.
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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.
Richard M Bergenstal, MD principal investigator
Park Nicollet Institute/International Diabetes Center
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 frequency of self monitoring blood glucose in people with Type 2 Diabetes, run by HealthPartners Institute 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 5 inclusion and 4 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 3 Dec 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.
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?
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?
HbA1c (time frame: 2 years). 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 3 Dec 2015.