Preventing Hypoglycemia

NCT01923688 | Completed

• 1 other identifier: 201104182
• Study Type: interventional
• Target: 390
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the project is to improve in-patient safety by lowering the risk of severe hypoglycemia (low blood sugar) for patients with diabetes on insulin therapy and to improve communication between healthcare providers. The procedures of the study are:

• the hospital patient information system \[Pharmacy Event System,(PES)\] will generate for healthcare providers a real-time risk alert of severe hypoglycemia (low blood sugar)
• the real-time PES risk alert will be sent via a beeper to the patient's charge nurse
• the charge nurse will follow the specific guidelines in the alert for assessment of the patient's care and insulin regimen
• the charge nurse will then notify the physician of the patient's assessment and of the recommendation for change/no change in insulin regimen and/or clinical care
• the alerted charge nurse and physician will complete a collaboration scale

Conditions

Diabetes

Keywords

Prediction Prevention Severe Hypoglycemia RealTime Alert

Outcome Measures

Primary Outcomes (1)

• Incidence of Severe Hypoglycemia

  The incidence of Severe Hypoglycemia (\<40mg/dl) in patients after receiving a PES Hypoglycemia Risk Alert until discharge from the hospital in both intervention and control groups.

  from time of the Pharmacy Expert System (PES) alert until discharge of the patient from the hospital, an average of 3-5 days

Study Arms (2)

Informatics Real-Time Alert

EXPERIMENTAL

Alert/Nurse and Physician Intervention

Other: Informatics Alert/Nurse/physician responders

control-no intervention

NO INTERVENTION

Interventions

Informatics Alert/Nurse/physician responders OTHER

Informatics Real-Time Alert

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Publications (12)

• Nirantharakumar K, Marshall T, Kennedy A, Narendran P, Hemming K, Coleman JJ. Hypoglycaemia is associated with increased length of stay and mortality in people with diabetes who are hospitalized. Diabet Med. 2012 Dec;29(12):e445-8. doi: 10.1111/dme.12002.

  PMID: 22937877 BACKGROUND

• Kagansky N, Levy S, Rimon E, Cojocaru L, Fridman A, Ozer Z, Knobler H. Hypoglycemia as a predictor of mortality in hospitalized elderly patients. Arch Intern Med. 2003 Aug 11-25;163(15):1825-9. doi: 10.1001/archinte.163.15.1825.

  PMID: 12912719 BACKGROUND

• Turchin A, Matheny ME, Shubina M, Scanlon JV, Greenwood B, Pendergrass ML. Hypoglycemia and clinical outcomes in patients with diabetes hospitalized in the general ward. Diabetes Care. 2009 Jul;32(7):1153-7. doi: 10.2337/dc08-2127.

  PMID: 19564471 BACKGROUND

• Desouza C, Salazar H, Cheong B, Murgo J, Fonseca V. Association of hypoglycemia and cardiac ischemia: a study based on continuous monitoring. Diabetes Care. 2003 May;26(5):1485-9. doi: 10.2337/diacare.26.5.1485.

  PMID: 12716809 BACKGROUND

• Schwartz AV, Vittinghoff E, Sellmeyer DE, Feingold KR, de Rekeneire N, Strotmeyer ES, Shorr RI, Vinik AI, Odden MC, Park SW, Faulkner KA, Harris TB; Health, Aging, and Body Composition Study. Diabetes-related complications, glycemic control, and falls in older adults. Diabetes Care. 2008 Mar;31(3):391-6. doi: 10.2337/dc07-1152. Epub 2007 Dec 4.

  PMID: 18056893 BACKGROUND

• Deal EN, Liu A, Wise LL, Honick KA, Tobin GS. Inpatient insulin orders: are patients getting what is prescribed? J Hosp Med. 2011 Nov;6(9):526-9. doi: 10.1002/jhm.938. Epub 2011 Oct 31.

  PMID: 22042479 BACKGROUND

• Elliott MB, Schafers SJ, McGill JB, Tobin GS. Prediction and prevention of treatment-related inpatient hypoglycemia. J Diabetes Sci Technol. 2012 Mar 1;6(2):302-9. doi: 10.1177/193229681200600213.

  PMID: 22538139 BACKGROUND

• ACE/ADA Task Force on Inpatient Diabetes. American College of Endocrinology and American Diabetes Association Consensus statement on inpatient diabetes and glycemic control. Diabetes Care. 2006 Aug;29(8):1955-62. doi: 10.2337/dc06-9913. No abstract available.

  PMID: 16873812 BACKGROUND

• Goldberg PA, Bozzo JE, Thomas PG, Mesmer MM, Sakharova OV, Radford MJ, Inzucchi SE. "Glucometrics"--assessing the quality of inpatient glucose management. Diabetes Technol Ther. 2006 Oct;8(5):560-9. doi: 10.1089/dia.2006.8.560.

  PMID: 17037970 BACKGROUND

• Kesten KS. Role-play using SBAR technique to improve observed communication skills in senior nursing students. J Nurs Educ. 2011 Feb;50(2):79-87. doi: 10.3928/01484834-20101230-02. Epub 2010 Dec 30.

  PMID: 21210611 BACKGROUND

• Hawkins K, Donihi AC, Korytkowski MT. Glycemic management in medical and surgical patients in the non-ICU setting. Curr Diab Rep. 2013 Feb;13(1):96-106. doi: 10.1007/s11892-012-0340-1.

  PMID: 23100037 BACKGROUND

• Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

  PMID: 8366922 BACKGROUND

Related Links

• Society of Hospital Medicine

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Garry Tobin, MD

  Washington University School of Medicine St. Louis, Missouri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 15, 2013
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 20, 2014

Record last verified: 2014-06