DiabetesPhase 4CARBNCT01333514
Carbohydrate Consumption as a Factor in Aspart Dosing
A Phase 4 study testing aspart and aspart- Insulin in people with Diabetes, run by Rush University Medical Center at 1 site in United States.
Trial summary
Good sugar control in postoperative hospitalized patient has been shown to improve wound healing and infection rates. However, sugar control is difficult to achieve and suboptimal use of insulin is thought to be a contributory factor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- aspart and aspart- Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2012
- Phase
- Phase 4
- 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
Who may be able to join
- Adults aged > or = to 18 admitted to general surgical floors, excluding the ICU, at Rush University Medical Center, regardless of race, ethnicity, gender
- Clinical diagnoses of type 2 diabetes for more than 6 months prior to admission
- Treated with insulin and/or 2 or more oral diabetic agents
- Estimated length of stay 3 days or more
- Postoperative point of care blood glucose of > 180 mg/dL
Who cannot join
- Glomerular Filtration Rate < 60 based on MDRD equation
- Pregnant patients
- Receiving parenteral or enteral nutrition
- Patients with an admitting diagnosis of hypoglycemia
- Outpatient insulin < 0.5 units/kg/day
- Inability to give consent
Show all 9Show fewer
- Severe liver disease
- Known hypopituitarism or adrenal insufficiency
- Treatment with Prednisone at dose > 5 mg daily or its equivalent
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Carbohydrate Consumption as a Factor in Aspart Dosing Compared to the Regularly Used Standard of Care Basis of Dosing Aspart in the Inpatient Setting (CARB)
Good sugar control in postoperative hospitalized patient has been shown to improve wound healing and infection rates. However, sugar control is difficult to achieve and suboptimal use of insulin is thought to be a contributory factor. Though it is known that generally the consumption of carbohydrates alone raises the blood sugar, the usual practice of dosing meal-time insulin is based on the fraction of the total meal-tray eaten which includes proteins, fats and carbohydrates. This leads to an overestimation of insulin required for a patient who consumes a portion of mainly proteins and fats on their trays or an underestimation for those eating mainly the carbohydrates on their tray. Low sugars or high blood sugars can follow respectively.
Hypothesis: The purpose of this study is to see if dosing meal-time insulin based on grams of carbohydrates consumed will result in better sugar control compared to the usual practice of dosing meal-time insulin based on percent of total meal consumed in hospitalized patients.
Read the detailed description
100 research subjects are expected to be enrolled in this study, all recruited from the Rush University Medical Center surgical (non-critical) services.
As is the usual care at Rush University Medical Center, patients who have type 2 diabetes and are on insulin and or at least two oral diabetes medications are given only insulin during their inpatient stay to control their blood sugar. It is the normal practice to use only insulin the hospital instead of pills for treating your diabetes. The use of insulin would be temporary and just during your hospital stay. When you return home, you will resume using pills.
Before the study begins, a computer system will randomly assign you a number, and those numbers belong to one of two groups. The number you have been given will determine which group you will go to. Throughout the study, you will be given a standard dose of basal insulin (Lantus). This dose will be your home dose if you are already using insulin. If you are not using insulin, you will be given a dose based on your weight.
During your stay, you will be given meal trays for breakfast, lunch, and dinner, and each of the food items belonging to your meal tray will be marked with at a certain number of carbohydrates. For example, ½ cup of cottage cheese will contain 4 grams of carbohydrates and one slice of whole wheat bread will contain 14 grams of carbohydrates and one 5 oz apple will contain 21 grams of carbohydrates. A dietician will then count the total amount of carbohydrates that you consume with each meal.
If you are assigned to the investigational arm of the study, you will be given a dose of mealtime insulin (Aspart) based on the number of carbohydrates you have consumed. If you are assigned to the control arm, you will be given your standard dose of mealtime insulin, if you eat more than 50% of your tray as is the usual practice at Rush, regardless of how much carbohydrate you eat. This dose will be your home dose if you are already using insulin or calculated based on your weight.
In either arm, if meals are not given (due to additional procedures or other reasons) the insulin dose will not be given. For both arms of the study, you will be requested not to eat any snacks containing carbohydrates. Instead you may be request for snacks that do not contain carbohydrates such string cheese which the investigators will provide.
Response to these therapies will be monitored by fingerstick glucose readings, also called point-of-care glucose. Your nurses will draw capillary blood, (less than 1 ml) via fingerstick on 4 occasions: pre-breakfast, pre-lunch, pre-dinner, and post-dinner / bedtime. These values will be sent to the study investigators, who will then adjust the amount of insulin that you are given.
In addition, your doctors will check a blood test called an A1c. This test measures the average sugar level in your blood over the last 90 days. This test is done on all patients with diabetes who are hospitalized.
- Conditions
- Diabetes
- Being tested
- aspart, aspart- Insulin
- Keywords
- diabetes, prandial, insulin, aspart, carbohydrate, inpatient, novolog
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspartDrug
Also called Novolog
Subjects will received aspart insulin subcutaneously based on the amount of carbohydrates consumed based on the formula 0.1 units/kg X (grams of carbohydrate eaten/75 grams carbohydrate)
aspart- InsulinDrug
Also called Novolog
0.1 units/kg of Aspart insulin will be given subcutaneously TID with meals if a subject eats 50% or more of their meal-tray
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate based prandial insulin dosing | Experimental | Subjects will received prandial insulin based on the amount of carbohydrates consumed. Receives: Drug: aspart |
| Usual Care Prandial insulin dosing | Active comparator | Subjects will received prandial insulin if they consume 50% or more of their meal-tray as is the usual care. Receives: Drug: aspart- Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of Hypoglycemia
Will determine if the probability of hypoglycemia in each arm; calculation details [i.e. "Experimental Event Rate (EER) = probability of outcome occurring in experimental group = a/(a+b)"]
Measured: measured 4 times/day until completion of study an average of 2 days
Secondary outcomes (1)
Probability of Hyperglycemia
Will determine if the probability of hyperglycemia in each arm; calculation details [i.e. "Experimental Event Rate (EER) = probability of outcome occurring in experimental group = a/(a+b)"]
Measured: blood sugars/4x day until completion of study, an average of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionDec 2012
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Kay Koh, Rush University Medical Center
- Investigators
- Chung-Kay Koh, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333514
- Sponsor's protocol ID
- 10040503
- Acronym
- CARB
- Status last verified
- Apr 2023
- First submitted
- 8 Apr 2011
- Last updated
- 1 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shilling AM, Raphael J. Diabetes, hyperglycemia, and infections. Best Pract Res Clin Anaesthesiol. 2008 Sep;22(3):519-35. doi: 10.1016/j.bpa.2008.06.005.
PubMed 18831301Cook CB, Castro JC, Schmidt RE, Gauthier SM, Whitaker MD, Roust LR, Argueta R, Hull BP, Zimmerman RS. Diabetes care in hospitalized noncritically ill patients: More evidence for clinical inertia and negative therapeutic momentum. J Hosp Med. 2007 Jul;2(4):203-11. doi: 10.1002/jhm.188.
PubMed 17683100Wexler DJ, Meigs JB, Cagliero E, Nathan DM, Grant RW. Prevalence of hyper- and hypoglycemia among inpatients with diabetes: a national survey of 44 U.S. hospitals. Diabetes Care. 2007 Feb;30(2):367-9. doi: 10.2337/dc06-1715. No abstract available.
PubMed 17259511Rabasa-Lhoret R, Garon J, Langelier H, Poisson D, Chiasson JL. Effects of meal carbohydrate content on insulin requirements in type 1 diabetic patients treated intensively with the basal-bolus (ultralente-regular) insulin regimen. Diabetes Care. 1999 May;22(5):667-73. doi: 10.2337/diacare.22.5.667.
PubMed 10332663
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbohydrate Consumption as a Factor in Aspart Dosing Compared to the Regularly Used Standard of Care Basis of Dosing Aspart in the Inpatient Setting (CARB)
- ClinicalTrials.gov ID
- NCT01333514
- Acronym / sponsor ID
- CARB / 10040503
- Conditions
- Diabetes
- Keywords
- diabetes, prandial, insulin, aspart, carbohydrate, inpatient, novolog
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Posted 1 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Good sugar control in postoperative hospitalized patient has been shown to improve wound healing and infection rates. However, sugar control is difficult to achieve and suboptimal use of insulin is thought to be a contributory factor. Though it is known that generally the consumption of carbohydrates alone raises the blood sugar, the usual practice of dosing meal-time insulin is based on the fraction of the total meal-tray eaten which includes proteins, fats and carbohydrates. This leads to an overestimation of insulin required for a patient who consumes a portion of mainly proteins and fats on their trays or an underestimation for those eating mainly the carbohydrates on their tray. Low sugars or high blood sugars can follow respectively.
Hypothesis: The purpose of this study is to see if dosing meal-time insulin based on grams of carbohydrates consumed will result in better sugar control compared to the usual practice of dosing meal-time insulin based on percent of total meal consumed in hospitalized patients.
Detailed description
100 research subjects are expected to be enrolled in this study, all recruited from the Rush University Medical Center surgical (non-critical) services.
As is the usual care at Rush University Medical Center, patients who have type 2 diabetes and are on insulin and or at least two oral diabetes medications are given only insulin during their inpatient stay to control their blood sugar. It is the normal practice to use only insulin the hospital instead of pills for treating your diabetes. The use of insulin would be temporary and just during your hospital stay. When you return home, you will resume using pills.
Before the study begins, a computer system will randomly assign you a number, and those numbers belong to one of two groups. The number you have been given will determine which group you will go to. Throughout the study, you will be given a standard dose of basal insulin (Lantus). This dose will be your home dose if you are already using insulin. If you are not using insulin, you will be given a dose based on your weight.
During your stay, you will be given meal trays for breakfast, lunch, and dinner, and each of the food items belonging to your meal tray will be marked with at a certain number of carbohydrates. For example, ½ cup of cottage cheese will contain 4 grams of carbohydrates and one slice of whole wheat bread will contain 14 grams of carbohydrates and one 5 oz apple will contain 21 grams of carbohydrates. A dietician will then count the total amount of carbohydrates that you consume with each meal.
If you are assigned to the investigational arm of the study, you will be given a dose of mealtime insulin (Aspart) based on the number of carbohydrates you have consumed. If you are assigned to the control arm, you will be given your standard dose of mealtime insulin, if you eat more than 50% of your tray as is the usual practice at Rush, regardless of how much carbohydrate you eat. This dose will be your home dose if you are already using insulin or calculated based on your weight.
In either arm, if meals are not given (due to additional procedures or other reasons) the insulin dose will not be given. For both arms of the study, you will be requested not to eat any snacks containing carbohydrates. Instead you may be request for snacks that do not contain carbohydrates such string cheese which the investigators will provide.
Response to these therapies will be monitored by fingerstick glucose readings, also called point-of-care glucose. Your nurses will draw capillary blood, (less than 1 ml) via fingerstick on 4 occasions: pre-breakfast, pre-lunch, pre-dinner, and post-dinner / bedtime. These values will be sent to the study investigators, who will then adjust the amount of insulin that you are given.
In addition, your doctors will check a blood test called an A1c. This test measures the average sugar level in your blood over the last 90 days. This test is done on all patients with diabetes who are hospitalized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate based prandial insulin dosing | Experimental | Drug: aspartSubjects will received prandial insulin based on the amount of carbohydrates consumed. |
| Usual Care Prandial insulin dosing | Active comparator | Drug: aspart- InsulinSubjects will received prandial insulin if they consume 50% or more of their meal-tray as is the usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged > or = to 18 admitted to general surgical floors, excluding the ICU, at Rush University Medical Center, regardless of race, ethnicity, gender
- Clinical diagnoses of type 2 diabetes for more than 6 months prior to admission
- Treated with insulin and/or 2 or more oral diabetic agents
- Estimated length of stay 3 days or more
- Postoperative point of care blood glucose of > 180 mg/dL
Key exclusion criteria (9 listed)
- Glomerular Filtration Rate < 60 based on MDRD equation
- Pregnant patients
- Receiving parenteral or enteral nutrition
- Patients with an admitting diagnosis of hypoglycemia
- Outpatient insulin < 0.5 units/kg/day
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 |
|---|---|---|
| aspartAlso: NovologSubjects will received aspart insulin subcutaneously based on the amount of carbohydrates consumed based on the formula 0.1 units/kg X (grams of carbohydrate eaten/75 grams carbohydrate) | Drug | Carbohydrate based prandial insulin dosing |
| aspart- InsulinAlso: Novolog0.1 units/kg of Aspart insulin will be given subcutaneously TID with meals if a subject eats 50% or more of their meal-tray | Drug | Usual Care Prandial insulin dosing |
Primary outcome
Probability of Hypoglycemia
Time frame: measured 4 times/day until completion of study an average of 2 days
Will determine if the probability of hypoglycemia in each arm; calculation details [i.e. "Experimental Event Rate (EER) = probability of outcome occurring in experimental group = a/(a+b)"]
1 secondary outcome
Probability of Hyperglycemia
Time frame: blood sugars/4x day until completion of study, an average of 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18831301Shilling AM, Raphael J. Diabetes, hyperglycemia, and infections. Best Pract Res Clin Anaesthesiol. 2008 Sep;22(3):519-35. doi: 10.1016/j.bpa.2008.06.005.
- Results publication: PubMed 17683100Cook CB, Castro JC, Schmidt RE, Gauthier SM, Whitaker MD, Roust LR, Argueta R, Hull BP, Zimmerman RS. Diabetes care in hospitalized noncritically ill patients: More evidence for clinical inertia and negative therapeutic momentum. J Hosp Med. 2007 Jul;2(4):203-11. doi: 10.1002/jhm.188.
- Results publication: PubMed 17259511Wexler DJ, Meigs JB, Cagliero E, Nathan DM, Grant RW. Prevalence of hyper- and hypoglycemia among inpatients with diabetes: a national survey of 44 U.S. hospitals. Diabetes Care. 2007 Feb;30(2):367-9. doi: 10.2337/dc06-1715. No abstract available.
- Results publication: PubMed 10332663Rabasa-Lhoret R, Garon J, Langelier H, Poisson D, Chiasson JL. Effects of meal carbohydrate content on insulin requirements in type 1 diabetic patients treated intensively with the basal-bolus (ultralente-regular) insulin regimen. Diabetes Care. 1999 May;22(5):667-73. doi: 10.2337/diacare.22.5.667.
- American College of Endocrinology and American Diabetes Association Consensus Statement on Inpatient Diabetes and Glycemic ControlLink provided by the sponsor.
- Rush University guidelines and protocols for the management of hyperglycemia in hospitalized patients: elimination of the sliding scale and improvement of glycemic control throughout the hospitalLink provided by the sponsor.
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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.
Chung-Kay Koh, MD principal investigator
Rush University Medical 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 aspart and aspart- Insulin in people with Diabetes, run by Rush University Medical 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 5 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: stopped early, as of the sponsor's last update on 1 May 2023. 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?
Yes. Results are posted in the registry (first posted 1 May 2023). 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?
Probability of Hypoglycemia (time frame: measured 4 times/day until completion of study an average of 2 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 NCT01333514, 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 1 May 2023.