Type 2 Diabetes MellitusNCT00874809
Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study
A study testing CGMS with an insulin pump using rapid acting insulin in people with Type 2 Diabetes Mellitus, run by Diabetes Care Center at 1 site in United States.
Trial summary
The main purpose of this study is to determine the number of daily basal insulin rate changes that are needed to achieve short-term near normal glucose control in insulin pump patients with type 2 diabetes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- CGMS with an insulin pump using rapid acting insulin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes > 3month duration
- Age 18
- Hb A1C <12%
- On any hypoglycemic therapy including insulin for 5 patients and 5 patients naive to insulin and failing oral treatment
- Normal creatine
- Negative for GAD antibodies
- SMBG >4/d and willing/able to comply with study requirements
- Demonstrated adherence to visits and instructions.
Who cannot join
- Severe hypoglycemic during the last month
- Severe cardiac, pulmonary or cerebral disease
- Demonstrated non compliance with clinical recommendations
- Pregnancy, nursing or women who could potentially become pregnant
- Presence of physical, psychological or cognitive impairments that would interfere with adherence to an intensive insulin therapy program or compliance with dietary, diary keeping or maintenance of CGM sensor or pump
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Explore Basal Insulin Dosing Requirements in Patients With Type 2 Diabetes Treated With Insulin Pump Therapy
The main purpose of this study is to determine the number of daily basal insulin rate changes that are needed to achieve short-term near normal glucose control in insulin pump patients with type 2 diabetes
Read the detailed description
Subjects will be taught CHO counting after which they will be introduced to an insulin pump. They will wear the insulin pump for three weeks to adjust to the pump and its functions. Then the subject will wear a Continuous Glucose Monitoring System to determine rate changes needed to achieve short-term near normal glucose control. The primary endpoint is what are the mean number of changes in the basal infusion rate and what are the mean differences and mean duration of these changes. The secondary endpoint is what mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by King and Armstrong.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- CGMS with an insulin pump using rapid acting insulin
- Keywords
- insulin pump, DM Type 2, CGMS, basal rate
- 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.
CGMS with an insulin pump using rapid acting insulinDevice
Also called Continuous Glucose Monitoring System (CGMS)
To determine basal changes subject will wear a CGMS with an insulin pump infusing rapid acting insulin
| Study group | Role | What they receive |
|---|---|---|
| Insulin Treatment | Other | There is only one arm for this study using lispro insulin administered by insulin pump. Receives: Device: CGMS with an insulin pump using rapid acting insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
What are the mean number of changes in the basal infusion rate(change is defined as any alternation in the basal rate >0.1 U/hr) and what are the mean differences and mean duration (hrs) of these changes.
Measured: week six of study
Secondary outcomes (1)
What mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by King and Armstrong
Measured: week 6 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetes Care Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Animas Corporation
- Responsible party
- Principal investigator, Allen B. King, MD, Diabetes Care Center
- Investigators
- Allen B King, MD, Principal investigator, Diabetes Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874809
- Sponsor's protocol ID
- 1799
- Status last verified
- Aug 2013
- First submitted
- 1 Apr 2009
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
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
- A Pilot Study to Explore Basal Insulin Dosing Requirements in Patients With Type 2 Diabetes Treated With Insulin Pump Therapy
- ClinicalTrials.gov ID
- NCT00874809
- Acronym / sponsor ID
- 1799
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- insulin pump, DM Type 2, CGMS, basal rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Diabetes Care CenterIndustry (pharma, biotech, devices)
- Collaborators
- Animas Corporation
- Study start
- Mar 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Apr 2009 (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 main purpose of this study is to determine the number of daily basal insulin rate changes that are needed to achieve short-term near normal glucose control in insulin pump patients with type 2 diabetes
Detailed description
Subjects will be taught CHO counting after which they will be introduced to an insulin pump. They will wear the insulin pump for three weeks to adjust to the pump and its functions. Then the subject will wear a Continuous Glucose Monitoring System to determine rate changes needed to achieve short-term near normal glucose control. The primary endpoint is what are the mean number of changes in the basal infusion rate and what are the mean differences and mean duration of these changes. The secondary endpoint is what mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by King and Armstrong.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin Treatment | Other | Device: CGMS with an insulin pump using rapid acting insulinThere is only one arm for this study using lispro insulin administered by insulin pump. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetes > 3month duration
- Age 18
- Hb A1C <12%
- On any hypoglycemic therapy including insulin for 5 patients and 5 patients naive to insulin and failing oral treatment
- Normal creatine
Key exclusion criteria (5 listed)
- Severe hypoglycemic during the last month
- Severe cardiac, pulmonary or cerebral disease
- Demonstrated non compliance with clinical recommendations
- Pregnancy, nursing or women who could potentially become pregnant
- Presence of physical, psychological or cognitive impairments that would interfere with adherence to an intensive insulin therapy program or compliance with dietary, diary keeping or maintenance of CGM sensor or pump
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 |
|---|---|---|
| CGMS with an insulin pump using rapid acting insulinAlso: Continuous Glucose Monitoring System (CGMS)To determine basal changes subject will wear a CGMS with an insulin pump infusing rapid acting insulin | Device | Insulin Treatment |
Primary outcome
What are the mean number of changes in the basal infusion rate(change is defined as any alternation in the basal rate >0.1 U/hr) and what are the mean differences and mean duration (hrs) of these changes.
Time frame: week six of study
1 secondary outcome
What mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by King and Armstrong
Time frame: week 6 of study
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.
Related trials for Type 2 Diabetes Mellitus
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
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.
Allen B King, MD principal investigator
Diabetes Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGMS with an insulin pump using rapid acting insulin in people with Type 2 Diabetes Mellitus, 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 5 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?
What are the mean number of changes in the basal infusion rate(change is defined as any alternation in the basal rate >0.1 U/hr) and what are the mean differences and mean duration (hrs) of these changes. (time frame: week six of study). 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 27 Aug 2013.