Effect of Inpatient Diabetes Management on Outpatient Glycemic Control

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00869362

Run by

Massachusetts General Hospital

People needed

31

Starts

2009-03-01

Expected to finish

2011-07-01

Last updated by the study team

2014-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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