Phase 4
N=126
Prandial Insulin Dosing in Hospitalized Patients
Diabetes · Admitting Hospital · Non-critically Ill
Bottom Line
View on ClinicalTrials.gov: NCT01101867 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Mean Glucose — 158; 171 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aspart fixed dose (Drug); Aspart flexible dose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kathleen Dungan
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Glucose |
158; 171 | — |
| SECONDARY Postprandial Glucose |
175; 203 | — |
| SECONDARY Hypoglycemia |
24; 14 | — |
| SECONDARY Change in Glucose |
-4.2; -8.1 | — |
| SECONDARY Treatment Satisfaction |
69; 68 | — |
| SECONDARY 1,5-anhydroglucitol Change |
0.41; 0.73 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01101867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.