Pharmacist Intervention for Glycemic Control in The Community

NCT01335763 | Completed

• 1 other identifier: LANTU_L_05128*
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

HbA1c; Multicentre before-after design; Glycemic control; Community pharmacists

Outcome Measures

Primary Outcomes (1)

• The change in HbA1c from baseline to week 26

  The change of the patients' HbA1c between the baseline and the 26 week visits

  6 months

Secondary Outcomes (6)

• Quality of life and patient satisfaction.

  6 months

• Proportion of patients achieving the target HbA1c

  6 months

• Type and degree of dosage changes in oral hypoglycemic agents

  6 months

• Persistence on insulin glargine

  6 months

• Safety

  6 months

Study Arms (1)

Insulin glargine

OTHER

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

Interventions

Insulin glargine DRUG

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

Also known as: Lantus

Insulin glargine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alberta: lead
• Sanofi: collaborator

Study Sites (1)

EPICORE Centre

Edmonton, Alberta, T6G 2C8, Canada

Location

Related Publications (2)

• Al Hamarneh YN, Sauriol L, Tsuyuki RT. After the diabetes care trial ends, now what? A 1-year follow-up of the RxING study. BMJ Open. 2015 Aug 12;5(8):e008152. doi: 10.1136/bmjopen-2015-008152.

  PMID: 26270946 DERIVED

• Al Hamarneh YN, Charrois T, Lewanczuk R, Tsuyuki RT. Pharmacist intervention for glycaemic control in the community (the RxING study). BMJ Open. 2013 Sep 24;3(9):e003154. doi: 10.1136/bmjopen-2013-003154.

  PMID: 24068762 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Cardiology) and Director, EPICORE Centre University of Alberta

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 14, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 6, 2013

Record last verified: 2012-08

Locations

CA (1)