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Pharmacist Intervention for Glycemic Control in The Community (RxING)

This study is currently recruiting participants.
Verified August 2012 by University of Alberta
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Ross T. Tsuyuki, University of Alberta
ClinicalTrials.gov Identifier:
NCT01335763
First received: April 13, 2011
Last updated: August 17, 2012
Last verified: August 2012
History of Changes
  Purpose

Background: Approximately 1.9 million Canadians are living with diabetes and this is estimated to increase by 75% over the next few decades. Pharmacists are front line primary healthcare professionals who see patients with diabetes frequently and in Alberta, they have been allowed to prescribe medications and order laboratory tests. As such, pharmacists could systematically identify poorly controlled diabetes patients and provide greater access to diabetes interventions to improve blood sugar control.

Objective: The aim of this study is to determine the effect of a community pharmacist intervention on blood sugar control in individuals with poorly controlled diabetes.

Project description:

100 adults with type 2 diabetes and uncontrolled blood sugar will be defined by the participating pharmacists. Blood sugar control is going to assessed using hemoglobin A1c test (a blood test to measure individual's blood sugar control over the last 3 months). This test requires obtaining a blood spot from the patient which will be obtained by pricking his/her fingertip. Based on the hemoglobin A1c test result the pharmacist will assess the patient's need for insulin glargine, if the patient needs insulin glargine the pharmacist is going to prescribe it for him/her and educate him/her on its use. Patients are going to be followed up closely by the pharmacists for 6 months with regular updates to the patients' family physicians. This multi-centre study should demonstrate pharmacists' ability to improve glycemic control and improve access to care.


Condition Intervention
Type 2 Diabetes
 Drug: Insulin glargine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacist Intervention for Glycemic Control in The Community (The RxING Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • The change in HbA1c from baseline to week 26 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The change of the patients' HbA1c between the baseline and the 26 week visits


Secondary Outcome Measures:
  • Quality of life and patient satisfaction. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quality of life and patient satisfaction is going to be measured through using the questionnaires Audit of Diabetes-Dependent Quality of Life (ADDQoL), Diabetes Treatment Satisfaction Questionnaire and Diabetes Treatment Satisfaction Questionnaire change (DTSQ and DTSQc)

  • Proportion of patients achieving the target HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Proportion of patients achieving HbA1c of ≤7.0% during follow-up

  • Type and degree of dosage changes in oral hypoglycemic agents [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The type and the degree of changes in the oral hypoglycemic dosing regimen

  • Persistence on insulin glargine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percentage of patients still taking insulin at the end of follow-up

  • Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Number of hypoglycemic episodes; symptomatic confirmed and severe (i.e., Requiring the help from a third party), as defined by the CDA guidelines

  • Health economic evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cost-effectiveness analyses from a healthcare payor (government) perspective. Costs will include pharmacist training, time spent with patients, pharmaceutical care processes (includes number of face-to-face meetings, time spent with the patient, number and duration of phone calls, number and type of testing per patient, equipment and testing costs, medication costs and out of pocket costs for patients). Clinical benefits will be estimated by modeling the A1C reduction with clinical trials estimates of event reductions


Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Insulin glargine
10 units at bedtime of insulin glargine will be prescribed to the patients who has HbA1c levels of 7.5-11%. Insulin glargine dose is going to be titrated by increments of 1 unit daily by the patient to achieve a morning fasting glucose of <=5.5mmol/L
 Drug: Insulin glargine
10 units at bedtime of insulin glargine will be prescribed to the patients who has HbA1c levels of 7.5-11%. Insulin glargine dose is going to be titrated by increments of 1 unit daily by the patient to achieve a morning fasting glucose of <=5.5mmol/L
Other Name: Lantus

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female over 18 years of age
  • Type 2 diabetes for at least 6 months
  • Taking 1 or more oral hypoglycemic agents
  • Patient attending your community pharmacy where you decided that addition of insulin glargine may be of benefit to the patient
  • Baseline HbA1c 7.5 - 11%
  • Signed informed consent

Exclusion Criteria:

  • Have used, or currently using, Insulin
  • History of ketoacidosis
  • Pregnant
  • Works night shift
  • Renal impairment(Serum Creatinine: females ≥ 124 mmol/l, males ≥ 133 mmol/l)
  • Clinically unstable
  • Unwilling/unable to attend follow up visits
  • Unlikely to adhere to study procedures (eg. due to cognitive limitations, severe psychiatric disorder or alcoholism)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335763

Contacts
Contact: Ross T Tsuyuki, Pharm D, MSc 780- 492-8526 ross.tsuyuki@ualberta.ca
Contact: Yazid N Al Hamarneh, Bsc Pharmacy, PhD 780- 492-9608 yazid.alhamarneh@ualberta.ca

Locations
Canada, Alberta
EPICORE Centre Recruiting
Edmonton, Alberta, Canada, T6G 2C8
Principal Investigator: Ross T Tsuyuki, PharmD, Msc            
Sub-Investigator: Yazid N Al Hamarneh, Bsc Pharmacy, PhD            
Sponsors and Collaborators
University of Alberta
Sanofi
  More Information

No publications provided

Responsible Party: Ross T. Tsuyuki, Professor of Medicine (Cardiology) and Director, EPICORE Centre University of Alberta, University of Alberta
ClinicalTrials.gov Identifier: NCT01335763     History of Changes
Other Study ID Numbers: LANTU_L_05128*
Study First Received: April 13, 2011
Last Updated: August 17, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
HbA1c
Multicentre before-after design
Glycemic control
Community pharmacists

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013