Type 2 DiabetesNCT01548222
CGM Evaluation of Glucose Excursions in Basal Insulin Treated T2DM at Fasting Glucose Target
An observational study of Type 2 Diabetes, run by Diabetes Care Center at 1 site in United States.
Trial summary
This is a trial to determine if patients who are well controlled and on basal insulin are treated with excessive basal dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from the Diabetes Care Center clinic
Who may be able to join
- Type 2 diabetes
- Age 18 years and above
- Concurrently on +/-thiazolidnedione +/-DDP IV inhibitors +/-metformin +/- glinides and basal insulin analogs
- A1C 10% or below
- Capable of self monitoring glucose at least 4 x a day
- Previously compliant with clinical recommendations
- Fasting blood glucose <110mg/dl average for 3 consecutive days
- BMI <45 kg/m
Who cannot join
- Urinary ketosis
- Current or expected alternation in insulin sensitivity such as major surgery, infection, renal failure, glucocorticoid treatment, recent serious hypoglycaemic episode
- Currently participating in another clinical trial
- Using rapid insulin insulin
- Pregnancy or nursing or the intention of becoming pregnant or not using adequate birth control
- Significant liver or heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
This is a trial to determine if patients who are well controlled and on basal insulin are treated with excessive basal dose.
Read the detailed description
In many clinical trials, basal insulin is titrated to only a fasting glucose goal. The usual final dose is >0.4U/kg. In carefully CGM monitored/titrated studies in both basal insulin alone or in pump-treated T2DM, we have found the basal insulin dose to be <0.3U/kg. This suggests that if guided by a single daily fasting glucose, titration may result in an excessive basal dose. This study will examine that issue.
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, continuous glucose, basal insulin
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time CGM glucose is <70mg/dl
The percentage of time CGM glucose is <70 mg/dl during the basal glucose evaluation
Measured: the subject will be followed for 9 days
Secondary outcomes (3)
Percentage of time CGM glucose is <40 mg/dl
The percentage of time the CGM glucose is <40 mg/dl
Measured: the subject will be followed for 9 days
Determined hypoglycaemic episodes
The percentage of subjects who perceived all CGM determined hypoglycaemic episodes
Measured: the subject will be followed for 9 days
Weight gain
The mean weight gain since initiating basal insulin fromo retrospectively gathered data.
Measured: the subject will be followed for 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetes Care Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548222
- Sponsor's protocol ID
- MM2012
- Status last verified
- Aug 2013
- First submitted
- 27 Feb 2012
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets - the TITRATE study. Diabetes Obes Metab. 2009 Jun;11(6):623-31. doi: 10.1111/j.1463-1326.2009.01060.x.
PubMed 19515182Meneghini L, Koenen C, Weng W, Selam JL. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes--results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab. 2007 Nov;9(6):902-13. doi: 10.1111/j.1463-1326.2007.00804.x.
PubMed 17924873Strange P. Treat-to-target insulin titration algorithms when initiating long or intermediate acting insulin in type 2 diabetes. J Diabetes Sci Technol. 2007 Jul;1(4):540-8. doi: 10.1177/193229680700100412.
PubMed 19885117King AB. Once-daily insulin detemir is comparable to once-daily insulin glargine in providing glycaemic control over 24 h in patients with type 2 diabetes: a double-blind, randomized, crossover study. Diabetes Obes Metab. 2009 Jan;11(1):69-71. doi: 10.1111/j.1463-1326.2008.01014.x.
PubMed 19120433
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CGM Evaluation of Glucose Excursions in Basal Insulin Treated T2DM at Fasting Glucose Target
- ClinicalTrials.gov ID
- NCT01548222
- Acronym / sponsor ID
- MM2012
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, continuous glucose, basal insulin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Diabetes Care CenterIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Mar 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.
This is a trial to determine if patients who are well controlled and on basal insulin are treated with excessive basal dose.
Detailed description
In many clinical trials, basal insulin is titrated to only a fasting glucose goal. The usual final dose is >0.4U/kg. In carefully CGM monitored/titrated studies in both basal insulin alone or in pump-treated T2DM, we have found the basal insulin dose to be <0.3U/kg. This suggests that if guided by a single daily fasting glucose, titration may result in an excessive basal dose. This study will examine that issue.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the Diabetes Care Center clinic
Key inclusion criteria (8 listed)
- Type 2 diabetes
- Age 18 years and above
- Concurrently on +/-thiazolidnedione +/-DDP IV inhibitors +/-metformin +/- glinides and basal insulin analogs
- A1C 10% or below
- Capable of self monitoring glucose at least 4 x a day
Key exclusion criteria (6 listed)
- Urinary ketosis
- Current or expected alternation in insulin sensitivity such as major surgery, infection, renal failure, glucocorticoid treatment, recent serious hypoglycaemic episode
- Currently participating in another clinical trial
- Using rapid insulin insulin
- Pregnancy or nursing or the intention of becoming pregnant or not using adequate birth control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of time CGM glucose is <70mg/dl
Time frame: the subject will be followed for 9 days
The percentage of time CGM glucose is <70 mg/dl during the basal glucose evaluation
3 secondary outcomes
Percentage of time CGM glucose is <40 mg/dl
Time frame: the subject will be followed for 9 days
Determined hypoglycaemic episodes
Time frame: the subject will be followed for 9 days
Weight gain
Time frame: the subject will be followed for 9 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 27 Aug 2013.
- Background: PubMed 19515182Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets - the TITRATE study. Diabetes Obes Metab. 2009 Jun;11(6):623-31. doi: 10.1111/j.1463-1326.2009.01060.x.
- Background: PubMed 17924873Meneghini L, Koenen C, Weng W, Selam JL. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes--results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab. 2007 Nov;9(6):902-13. doi: 10.1111/j.1463-1326.2007.00804.x.
- Results publication: PubMed 19885117Strange P. Treat-to-target insulin titration algorithms when initiating long or intermediate acting insulin in type 2 diabetes. J Diabetes Sci Technol. 2007 Jul;1(4):540-8. doi: 10.1177/193229680700100412.
- Results publication: PubMed 19120433King AB. Once-daily insulin detemir is comparable to once-daily insulin glargine in providing glycaemic control over 24 h in patients with type 2 diabetes: a double-blind, randomized, crossover study. Diabetes Obes Metab. 2009 Jan;11(1):69-71. doi: 10.1111/j.1463-1326.2008.01014.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetes Care 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 8 inclusion and 6 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 27 Aug 2013. 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?
Percentage of time CGM glucose is <70mg/dl (time frame: the subject will be followed for 9 days). 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 NCT01548222, which also lists 4 linked publications.
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 27 Aug 2013.