Phase 4
Completed N=82
Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir
Source: ClinicalTrials.gov NCT00717288 ↗Enrolled (actual)
82
Serious AEs
1.2%
Results posted
Oct 2011
Primary outcomePrimary: Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3 — 10; 18; 14 participants
Summary
In this study we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3 |
10; 18; 14 | — |
| SECONDARY Patients With Hypoglycemia (Defined as Glucose <65 mg/dl) |
0; 6; 3 | — |
| SECONDARY Reversion to Intravenous Insulin for Failure of Glycemic Control |
2; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- diabetes mellitus
- post-cardiothoracic surgery
- requiring an insulin infusion of at least 1 unit/hour
- Age 18-75
Exclusion Criteria
- Glucocorticoids
- total parenteral nutrition (TPN) or tube feeds
- Pregnancy
- Surgical procedures in the next 48 hours for whom intravenous (IV) insulin will be expected
- Expected length of stay less than 48 hours following cessation of the insulin drip
- Patients using subcutaneous insulin pumps
- Diabetic ketoacidosis
- End-stage renal disease
- End-stage liver disease
- Coma
- Potentially sensitive admissions: prisoners, human immunodeficiency virus(HIV), suicidality
- Unable to give consent in English
Data sourced from ClinicalTrials.gov (NCT00717288). 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. Informational only — not medical advice.