Prandial Insulin Dosing in Hospitalized Patients

Phase 4

Completed

• Conditions: Diabetes; Admitting Hospital; Non-critically Ill
• Interventions: Drug: Aspart flexible dose; Drug: Aspart fixed dose

• Registration Number: NCT01101867
• Lead Sponsor: Kathleen Dungan

Brief Summary

The purpose of this study is to determine whether mealtime insulin results in better control of blood sugar than a fixed meal dose in hospitalized patients.

Detailed Description

The purpose of this study is to determine whether mealtime insulin, dosed to match the intake of carbohydrates (starches or sugars) results in better control of blood sugar than a fixed meal dose in hospitalized patients.

Study Timeline

• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-12
• Study Start: 2010-06
• Primary Completion: 2012-06
• Study Completion: 2013-03
• Results First Submitted: 2013-04-09
• Results First Submitted QC: 2013-05-28
• Results First Posted: 2013-07-02
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-03
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• general medical or minor surgical hospitalized patients
• type 2 diabetes
• blood glucose 150-400 on at least 2 occasions within 24 hours or requiring at least 20 units of insulin/day in the 24 hours prior to enrollment

Exclusion Criteria

• • Major surgery, occurring within the previous 2 weeks or planned within 72 hours of study entry, including cardiothoracic, neurosurgical, and open intra-abdominal procedures (in particular, any surgery lasting over 2 hours).

  • Patients receiving glucocorticoids, total parental nutrition (TPN), or tube feeds.
  • Pregnancy (glucose targets differ in pregnancy). Premenopausal women not on pharmacologic contraceptives, inrauterine device (IUD), or surgical menopause will undergo pregnancy testing.
  • Patients currently on IV insulin (must wait to enroll) or with planned surgical procedures in the next 72 hours for whom intravenous insulin will be likely
  • Prolonged (>24 hour) strict nil per os (NPO-nothing by mouth) status (eg. small bowl obstruction). Liquid or modified consistency diets are acceptable.
  • Patients for whom expected length of stay will be less than 48 hours
  • Patients using subcutaneous insulin pumps
  • Diabetic ketoacidosis
  • End-stage renal disease on dialysis
  • End-stage liver disease with cirrhosis
  • Mental conditions precluding informed consent
  • Potentially sensitive admissions: prisoners, HIV, suicidality
  • Unable to give consent in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspart flexible dose	Aspart flexible dose	aspart dose determined based upon carbohydrate intake.
Aspart fixed dose	Aspart fixed dose	fixed meal dose of aspart (based upon weight or total daily insulin dose)

Primary Outcome Measures

Name	Time	Method
Mean Glucose	day 3	Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3

Secondary Outcome Measures

Name	Time	Method
Postprandial Glucose	day 3	Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3.
Hypoglycemia	72 hour	Number of patients with any hypoglycemic event (\<70 mg/dl or \<40 mg/dl)
Change in Glucose	72 hour	Change in mean glucose from day 1 to day 3, measured as difference in mean glucose day 3 minus mean glucose day 1.
Treatment Satisfaction	day 3	treatment satisfaction questionnaire validated in-hospital, 19 item questionnaire using 0-6 point likert scale, for minimum zero to maximum of 102 points (with 102 indicating best satisfaction). Items are summed to find the total score.
1,5-anhydroglucitol Change	day 1 to day 3	change in short-term measure of glycemia

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States