Effect of Inpatient Diabetes Management on Outpatient Glycemic Control

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of Inpatient Diabetes Management on Outpatient Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869362
• Other study ID #: 2008P-001439
• Secondary ID: K23DK080228
• Status: Completed
• Phase: N/A
• First received: March 25, 2009
• Last updated: October 27, 2014
• Start date: March 2009
• Est. completion date: July 2011

Study information

• Verified date: October 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• Diabetes management team
MD evaluation followed by NP education and and medication titration

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Change in glycemic control measured by HbA1c change baseline to 6 months	6 months from discharge	No
Secondary	Average Intervention Effect Over 12 Months After Hospital Discharge		12 months from discharge	No