Effect of Inpatient Diabetes Management on Outpatient Glycemic Control

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Deborah Wexler, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00869362
First received: March 25, 2009
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Other: Diabetes management team

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Inpatient Diabetes Management on Outpatient Glycemic Control

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 6 months from discharge ] [ Designated as safety issue: No ]
    Change in glycemic control measured by HbA1c change baseline to 6 months


Secondary Outcome Measures:
  • Average Intervention Effect Over 12 Months After Hospital Discharge [ Time Frame: 12 months from discharge ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: March 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diabetes Management Team
Evaluation and management by diabetes management team
Other: Diabetes management team
MD evaluation followed by NP education and and medication titration
No Intervention: Control
Patients receive usual care for diabetes

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869362

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Deborah J Wexler, MD, MSc Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deborah Wexler, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00869362     History of Changes
Other Study ID Numbers: 2008P-001439
Study First Received: March 25, 2009
Results First Received: October 3, 2012
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014