Type 2 Diabetes MellitusDexlonT2NCT01341067
Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus, run by Rocky Mountain Diabetes and Osteoporosis Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect CGM (continuous glucose monitoring) has on subjects with type 2 diabetes. It is anticipated that patients using the device will obtain tighter control of their blood sugars resulting in measureable health benefits and improved confidence in their ability to manage… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 of all adult ages (18 and older) with type 2 diabetes.
Who may be able to join
- Have been diagnosed with type 2 diabetes mellitus
- Have an HgbA1c value ≥ 7% and ≤17%.
- Are on basal insulin, with or without oral agents
- Are not on basal bolus insulin therapy.
- Have had no severe hypoglycemic episodes in the 6 months prior to enrollment in the study. Severe hypoglycemia will be defined as any hypoglycemia that is both neurologically impairing and absolutely requires assistance from a third party in the form of carbohydrates, glucagon shots, or attention from a paramedic or other healthcare professional.
- Have no known allergy to medical tape or sensors.
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- Are capable of and willing to test their blood glucose (BG) on an average of 4 times per day.
- Are willing to not use Acetaminophen while enrolled in the study.
- Are willing not to undergo a MRI procedure while wearing the CGM sensor.
- Are willing and capable of performing self insertions of the device sensor.
- Women of child bearing potential must be willing to use an approved form of birth control while enrolled in the study.
- Women of child bearing potential must be willing to perform pregnancy tests monthly while enrolled in the study.
- Can understand and speak English fluently.
Who cannot join
- Have been on pump therapy in the 6 months prior to enrollment in the study.
- Are receiving basal- bolus insulin therapy
- Are taking any medication that is not approved to be taken with insulin.
- Are pregnant or have intentions of becoming pregnant during the duration of the study.
- Have any skin condition that would inhibit the proper wearing of the CGM sensor including severe psoriasis, burns, eczema, scarring, excessive tattoos, etc.
- Have a hematocrit ≤30% or ≥55%
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- Are currently enrolled in another clinical study (subjects must have ended participation in other studies at least 30 days prior to enrolling in this study.
- Are employed by any company that manufactures or is developing a CGM device.
- Are deemed incapable of participating in the study by the Primary Investigator for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
About this study
Official title: Continuous Glucose Monitoring in Subjects With Type 2 Diabetes
The purpose of this study is to examine the effect CGM (continuous glucose monitoring) has on subjects with type 2 diabetes. It is anticipated that patients using the device will obtain tighter control of their blood sugars resulting in measureable health benefits and improved confidence in their ability to manage their diabetes.
- Conditions
- Type 2 Diabetes Mellitus
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Basal insulin, approved oral medications | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HgbA1c
Measured: Measured at 6 months
Secondary outcomes (3)
Percentage of Time Spent at Glycemic Levels <65 mg/dl
Measured: Measured at baseline and at 6 months
Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl
Measured: Measured at baseline and 6 months
Change in Basal Insulin Dose From Baseline Values
Measured: Assessed at baseline 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 posted25 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rocky Mountain Diabetes and Osteoporosis Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, David Liljenquist, M.D., Rocky Mountain Diabetes and Osteoporosis Center
- Investigators
- David R. Liljenquist, MD, Principal investigator, Rocky Mountain Diabetes and Osteoporosis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341067
- Sponsor's protocol ID
- RMDC-001
- Acronym
- DexlonT2
- Status last verified
- Apr 2014
- First submitted
- 21 Apr 2011
- Last updated
- 2 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01341067
- Acronym / sponsor ID
- DexlonT2 / RMDC-001
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rocky Mountain Diabetes and Osteoporosis CenterIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Apr 2011 (estimated)
- Results
- Posted 2 May 2014
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 examine the effect CGM (continuous glucose monitoring) has on subjects with type 2 diabetes. It is anticipated that patients using the device will obtain tighter control of their blood sugars resulting in measureable health benefits and improved confidence in their ability to manage their diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basal insulin, approved oral medications | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects of all adult ages (18 and older) with type 2 diabetes.
Key inclusion criteria (13 listed)
- Have been diagnosed with type 2 diabetes mellitus
- Have an HgbA1c value ≥ 7% and ≤17%.
- Are on basal insulin, with or without oral agents
- Are not on basal bolus insulin therapy.
- Have had no severe hypoglycemic episodes in the 6 months prior to enrollment in the study. Severe hypoglycemia will be defined as any hypoglycemia that is both neurologically impairing and absolutely requires assistance from a third party in the form of carbohydrates, glucagon shots, or attention from a paramedic or other healthcare professional.
Key exclusion criteria (9 listed)
- Have been on pump therapy in the 6 months prior to enrollment in the study.
- Are receiving basal- bolus insulin therapy
- Are taking any medication that is not approved to be taken with insulin.
- Are pregnant or have intentions of becoming pregnant during the duration of the study.
- Have any skin condition that would inhibit the proper wearing of the CGM sensor including severe psoriasis, burns, eczema, scarring, excessive tattoos, etc.
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
Change in HgbA1c
Time frame: Measured at 6 months
3 secondary outcomes
Percentage of Time Spent at Glycemic Levels <65 mg/dl
Time frame: Measured at baseline and at 6 months
Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl
Time frame: Measured at baseline and 6 months
Change in Basal Insulin Dose From Baseline Values
Time frame: Assessed at baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David R. Liljenquist, MD principal investigator
Rocky Mountain Diabetes and Osteoporosis Center
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 Mellitus, run by Rocky Mountain Diabetes and Osteoporosis 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 13 inclusion and 9 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 2 May 2014. 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?
Yes. Results are posted in the registry (first posted 2 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 HgbA1c (time frame: Measured at 6 months). 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 2 May 2014.