Diabetes Mellitus Type 1NCT01045954
A Study of the Rules for Insulin Dosing in Patients Using Multiple Daily Injections
A study testing Lispro Insulin and glargine insulin in people with Diabetes Mellitus Type 1, run by Diabetes Care Center at 1 site in United States.
Trial summary
This study will be conducted in subjects with Type 1 diabetes mellitus on multiple daily insulin injections to determine the correct insulin dosing formulas. Subjects will be evaluated using continuous glucose monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- Lispro Insulin and glargine insulin
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Oct 2010
- 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
- Age: >17 years
- Type 1 diabetes
- Diabetes duration > 3 months
- On treatment with multiple daily injections either one or more basal insulin injections each day for 6 weeks
- HbA1c <9.0%
- Stable HbA1c in the proceeding 3 months (i.e., change <1%)
- Demonstrated adherence to visits and instructions
- Attend a class in meal carbohydrate content estimation or have demonstrated knowledge of carbohydrate counting
Who cannot join
- Major stress event during or for 6 weeks before the evaluation
- Taking a medication that can alter insulin sensitivity
- Within one week of menses
- Unstable eating or activity pattern
- Pregnancy
- Weight gain of > 1.5 kg during the preceding 3 months
Show all 11Show fewer
- Serum creatinine of >1.5 mg/dl
- Active liver disease
- Evidence of autonomic neuropathy, especially gastroparesis
- Any antidiabetic medication other than insulin
- Treatment with continuous subcutaneous insulin infusion
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Diabetes Care Center
Salinas, California, 93901
Gary S Wolfe, RN, 831-769-9355, gwolfe@diabetescarecenter.com
Allen B King, MD
About this study
This study will be conducted in subjects with Type 1 diabetes mellitus on multiple daily insulin injections to determine the correct insulin dosing formulas. Subjects will be evaluated using continuous glucose monitoring.
Read the detailed description
Subjects with stable type 1 diabetes mellitus on multiple daily insulin injections including basal and bolus will be selected in order to determine the correct insulin dosing formulas. Subjects will be placed on continuous glucose sensor (CGMS) and an isocaloric diet. Subjects will have the CGMS downloaded daily and the insulin doses adjusted if necessary. Subject will do four SMBGs daily to calibrate CGMS and on last day a 7-point SMBG. subjects will be on lispro and glargine insulin. Basal insulin will be once a day.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- Lispro Insulin and glargine insulin
- Keywords
- diabetes mellitus type 1, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lispro Insulin and glargine insulinDrug
Continuous glucose sensor will be inserted. Subject will be on an isocaloric diet and CGM downloaded daily. Insulin basal and bolus will be adjusted based upon treatment goals until goals reached
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the mean value for the slop between the variables of total daily dose versus total basal dose.
Measured: Two weeks
Secondary outcomes (1)
Determine the slope between the other variables: weight, total daily dose, total basal dose, insulin correction carbohydrate rate, correction factor
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 1Studies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetes Care Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Allen B. King, MD, Principal investigator, Diabetes Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045954
- Sponsor's protocol ID
- DCC 02-09
- Status last verified
- Jan 2010
- First submitted
- 7 Jan 2010
- Last updated
- 11 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Walsh J, Roberts R. Pumping Insulin. 3rd Edition, San Diego, Torrey Pines Press. 2000
Bode BW. Insulin Pump Therapy. In, Therapy for diabetes Mellitus and Related Disorders, fourth edition, Lebovitz H. Ed, Alexandria, VA, American Diabetes Association, 2004, p224-231
King AB, Armstrong DU. A prospective evaluation of insulin dosing recommendations in patients with type 1 diabetes at near normal glucose control: bolus dosing. J Diabetes Sci Technol. 2007 Jan;1(1):42-6. doi: 10.1177/193229680700100107.
PubMed 19888378King AB, Armstrong DU. A prospective evaluation of insulin dosing recommendations in patients with type 1 diabetes at near normal glucose control: Basal dosing. J Diabetes Sci Technol. 2007 Jan;1(1):36-41. doi: 10.1177/193229680700100106.
PubMed 19888377Davidson PC, Hebblewhite HR, Bode BW, et al. Statistically based CSII parameters correction factor, CF (1700 rule) carbohydrate-to-insulin ratio, CIR (2.8 rule) and basal-to-total ration. Diabetes Technol Ther. 2003; 3:237
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Rules for Insulin Dosing in Patients Using Multiple Daily Injections
- ClinicalTrials.gov ID
- NCT01045954
- Acronym / sponsor ID
- DCC 02-09
- Conditions
- Diabetes Mellitus Type 1
- Keywords
- diabetes mellitus type 1, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Diabetes Care CenterIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 11 Jan 2010 (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 study will be conducted in subjects with Type 1 diabetes mellitus on multiple daily insulin injections to determine the correct insulin dosing formulas. Subjects will be evaluated using continuous glucose monitoring.
Detailed description
Subjects with stable type 1 diabetes mellitus on multiple daily insulin injections including basal and bolus will be selected in order to determine the correct insulin dosing formulas. Subjects will be placed on continuous glucose sensor (CGMS) and an isocaloric diet. Subjects will have the CGMS downloaded daily and the insulin doses adjusted if necessary. Subject will do four SMBGs daily to calibrate CGMS and on last day a 7-point SMBG. subjects will be on lispro and glargine insulin. Basal insulin will be once a day.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: >17 years
- Type 1 diabetes
- Diabetes duration > 3 months
- On treatment with multiple daily injections either one or more basal insulin injections each day for 6 weeks
- HbA1c <9.0%
Key exclusion criteria (11 listed)
- Major stress event during or for 6 weeks before the evaluation
- Taking a medication that can alter insulin sensitivity
- Within one week of menses
- Unstable eating or activity pattern
- Pregnancy
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 |
|---|---|---|
| Lispro Insulin and glargine insulinContinuous glucose sensor will be inserted. Subject will be on an isocaloric diet and CGM downloaded daily. Insulin basal and bolus will be adjusted based upon treatment goals until goals reached | Drug | – |
Primary outcome
Determine the mean value for the slop between the variables of total daily dose versus total basal dose.
Time frame: Two weeks
1 secondary outcome
Determine the slope between the other variables: weight, total daily dose, total basal dose, insulin correction carbohydrate rate, correction factor
Time frame: Two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2010.
- BackgroundWalsh J, Roberts R. Pumping Insulin. 3rd Edition, San Diego, Torrey Pines Press. 2000
- BackgroundBode BW. Insulin Pump Therapy. In, Therapy for diabetes Mellitus and Related Disorders, fourth edition, Lebovitz H. Ed, Alexandria, VA, American Diabetes Association, 2004, p224-231
- Background: PubMed 19888378King AB, Armstrong DU. A prospective evaluation of insulin dosing recommendations in patients with type 1 diabetes at near normal glucose control: bolus dosing. J Diabetes Sci Technol. 2007 Jan;1(1):42-6. doi: 10.1177/193229680700100107.
- Background: PubMed 19888377King AB, Armstrong DU. A prospective evaluation of insulin dosing recommendations in patients with type 1 diabetes at near normal glucose control: Basal dosing. J Diabetes Sci Technol. 2007 Jan;1(1):36-41. doi: 10.1177/193229680700100106.
- BackgroundDavidson PC, Hebblewhite HR, Bode BW, et al. Statistically based CSII parameters correction factor, CF (1700 rule) carbohydrate-to-insulin ratio, CIR (2.8 rule) and basal-to-total ration. Diabetes Technol Ther. 2003; 3:237
Related trials for Diabetes Mellitus Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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 Lispro Insulin and glargine insulin in people with Diabetes Mellitus Type 1, 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 11 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: status not confirmed, as of the sponsor's last update on 11 Jan 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gary W Wolfe, RN (831-769-9355, gwolfe@diabetescarecenter.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the mean value for the slop between the variables of total daily dose versus total basal dose. (time frame: Two weeks). 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 NCT01045954, which also lists 5 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 11 Jan 2010.