Status:
COMPLETED
Effect of Inpatient Diabetes Management on Outpatient Glycemic Control
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 targete...
Detailed Description
The study is a randomized, controlled trial of targeted inpatient diabetes management versus usual care in 70 general medical and surgical inpatients over age 18 with type 2 diabetes and hemoglobin A1...
Eligibility Criteria
Inclusion
- 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
- Screening HbA1c returns less than 8%.
- Diabetic ketoacidosis (DKA) as a primary reason for admission (admission blood glucose \> 250 mg/dl with arterial pH \< 7.30 or serum bicarbonate level \< 15 mg/dl), or development of DKA during admission.
- Hyperosmolar hyperglycemic syndrome as a primary reason for admission (admission blood glucose \> 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 \< 9 g/dl, recent blood transfusion, or need for blood transfusion (interferes with interpretation of hemoglobin A1c assay)
- End stage liver disease with prothrombin time \> 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00869362
Start Date
March 1 2009
End Date
July 1 2011
Last Update
November 4 2014
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114