N/A
Completed N=31
Effect of Inpatient Diabetes Management on Outpatient Glycemic Control
Source: ClinicalTrials.gov NCT00869362 ↗Enrolled (actual)
31
Serious AEs
6.5%
Results posted
Nov 2012
Primary outcomePrimary: Hemoglobin A1c — -1.3; -0.4 HbA1c, %
Summary
The hypothesis of this study is that using hospital admission to identify patients with poorly controlled diabetes (hemoglobin A1c levels >8%), and intervening during the hospitalization with targeted inpatient diabetes management will improve glycemic control at 3 and 12 months, with inpatient glycemic control, quality of life, and diabetes self-efficacy serving as secondary endpoints.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c |
-1.3; -0.4 | — |
| SECONDARY Average Intervention Effect Over 12 Months After Hospital Discharge |
-0.6; -0.6 | — |
Eligibility Criteria
Inclusion Criteria
- Age > 18 years
- Known diagnosis of type 2 diabetes by history with outpatient prescription of oral hypoglycemic medication or insulin
- Hemoglobin A1c > 8.0% within the prior 12 months, or if not known, fasting blood glucose greater than 200 mg/dl on sliding scale regular insulin.
- Partners-affiliated primary care physician
Exclusion Criteria
- Screening HbA1c returns less than 8%.
- Diabetic ketoacidosis (DKA) as a primary reason for admission (admission blood glucose > 250 mg/dl with arterial pH 400 mg/dl and plasma osmolality > 315 mOsm/kg.
- Pregnancy, ruled out by urine HCG test at screening after consent is obtained in all women who continue to have menstrual cycles.
- Anemia with hemoglobin 15 seconds and albumin <3 mg/dl
- End stage renal disease: Stage IV (glomerular filtration rate <30 mg/dl) or V chronic kidney disease
- Treatment with corticosteroids
- ICU transfer
- Inability to self-administer insulin
- Hypoglycemia unawareness: patient lacks sensation of common signs of blood glucose < 60 mg/dl (tachycardia, diaphoresis, hunger, confusion, fatigue).
- Projected survival < 1 year
Data sourced from ClinicalTrials.gov (NCT00869362). 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.