Clinical trial NCT00869362: Effect of Inpatient Diabetes Management on Outpatient Glycemic Control
Official title: Effect of Inpatient Diabetes Management on Outpatient Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-03-26
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 A1c levels greater than 8% who are followed in Partners-affiliated primary care practices. In addition, we will enroll a prospective chart review cohort matched for age, sex, and HbA1c level whose course we will follow for one year after discharge to determine the patter of glycemia among patients who are not enrolled in a clinical trial.

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 \< 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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 6 months from discharge
Secondary outcomes:
measure: Average Intervention Effect Over 12 Months After Hospital Discharge
timeFrame: 12 months from discharge
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Deborah J Wexler, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wexler DJ, Beauharnais CC, Regan S, Nathan DM, Cagliero E, Larkin ME. Impact of inpatient diabetes management, education, and improved discharge transition on glycemic control 12 months after discharge. Diabetes Res Clin Pract. 2012 Nov;98(2):249-56. doi: 10.1016/j.diabres.2012.09.016. Epub 2012 Oct 1.