NCT00869362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 2, 2012

Completed
Last Updated

November 4, 2014

Status Verified

October 1, 2014

Enrollment Period

2.3 years

First QC Date

March 25, 2009

Results QC Date

October 3, 2012

Last Update Submit

October 27, 2014

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    Change in glycemic control measured by HbA1c change baseline to 6 months

    6 months from discharge

Secondary Outcomes (1)

  • Average Intervention Effect Over 12 Months After Hospital Discharge

    12 months from discharge

Study Arms (2)

Diabetes Management Team

EXPERIMENTAL

Evaluation and management by diabetes management team

Other: Diabetes management team

Control

NO INTERVENTION

Patients receive usual care for diabetes

Interventions

Diabetes management teamOTHER

MD evaluation followed by NP education and and medication titration

Diabetes Management Team

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related 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: 10.1016/j.diabres.2012.09.016. Epub 2012 Oct 1.

    PMID: 23036785RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Deborah J. Wexler MD
Organization
Massachusetts General Hospital Diabetes Center
dwexler@partners.org
617-726-8722

Study Officials

  • Deborah J Wexler, MD, MSc

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

November 4, 2014

Results First Posted

November 2, 2012

Record last verified: 2014-10

Locations

US(1)