Carbohydrate Consumption as a Factor in Aspart Dosing

NCT01333514 | Terminated Phase 4 Results

• 1 other identifier: 10040503
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes

Keywords

diabetes; prandial; insulin; aspart; carbohydrate; inpatient; novolog

Outcome Measures

Primary Outcomes (1)

• 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 4 times/day until completion of study an average of 2 days

Secondary Outcomes (1)

• Probability of Hyperglycemia

  blood sugars/4x day until completion of study, an average of 2 days

Study Arms (2)

Carbohydrate based prandial insulin dosing

EXPERIMENTAL

Subjects will received prandial insulin based on the amount of carbohydrates consumed.

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.

Drug: aspart- Insulin

Interventions

aspart DRUG

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)

Also known as: Novolog

Carbohydrate based prandial insulin dosing

aspart- Insulin DRUG

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

Also known as: Novolog

Usual Care Prandial insulin dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Severe liver disease
• Known hypopituitarism or adrenal insufficiency
• Treatment with Prednisone at dose \> 5 mg daily or its equivalent

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

• 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.

  PMID: 18831301 BACKGROUND

• Cook 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.

  PMID: 17683100 RESULT

• Wexler 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.

  PMID: 17259511 RESULT

• Rabasa-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.

  PMID: 10332663 RESULT

Related Links

• American College of Endocrinology and American Diabetes Association Consensus Statement on Inpatient Diabetes and Glycemic Control

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Early termination due to the PI becoming sick early in the study.

Results Point of Contact

• Title: Chung-Kay Koh
• Organization: Rush University Medical Center

chungkay@gmail.com

8475305230

Study Officials

• Chung-Kay Koh, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 12, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 1, 2023
• Results First Posted: May 1, 2023

Record last verified: 2023-04

Locations

US (1)