Type 2 DiabetesRxINGNCT01335763
Pharmacist Intervention for Glycemic Control in The Community
A study testing Insulin glargine in people with Type 2 Diabetes, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Insulin glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacist Intervention for Glycemic Control in The Community (The RxING Study)
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.
Read more
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.
Read the detailed description
BACKGROUND/RATIONALE:
Approximately 1.9 million Canadians are living with diabetes. Estimates are that this number will increase by 75% over the next few decades. Glycemic control in patients with type 2 diabetes mellitus is poor, and poorly controlled patients contribute significantly to the cost of primary health care in Canada. 10% of all acute care hospital admissions in 2006 were attributed to diabetes and its complications.
As type 2 diabetes is a progressive disease, most patients with type 2 diabetes will eventually require insulin. In patients who present with type 2 diabetes and a HbA1C over 9%, insulin can be started immediately, however, historically physicians generally perceive their to be patient difficulties in starting insulin therapy.
INSIGHT demonstrated improved glycemic control with addition of insulin glargine to oral hypoglycemic agents in patients with type 2 diabetes. However, physicians are often reluctant to initiate insulin in these patients. In addition, physicians do not have a system to systematically identify potential candidates for insulin add-on therapy
Pharmacists are front line primary care professionals who see patients with diabetes more frequently than family physicians and as such, could systematically and proactively identify patients with type 2 diabetes with poor glycemic control as a public health approach to chronic disease management. This approach has been used successfully by our group in the past with dyslipidemia and hypertension management involving patients with diabetes.
The scope of practice for pharmacists is changing, with legislation in Alberta (and soon other provinces) allowing pharmacists to prescribe Schedule I medications and order laboratory tests. As such, there is an opportunity to provide greater access, convenience and improved glycemic control by engaging community pharmacists and their patients.
PRIMARY OBJECTIVE: To determine the effect of a community pharmacist prescribing intervention on glycemic control in patients with poorly controlled type 2 diabetes.
SECONDARY OBJECTIVES:
- To determine the effects of pharmacist-directed diabetes care focusing on glycemic control on:
- patient satisfaction
- quality of life
- dosage changes of oral agents
- persistence on insulin glargine and the end of follow-up
- hypoglycemic episodes
- To conduct a health economic assessment of the costs and benefits of the intervention
METHODS:
Design: multicentre pragmatic before-after design trial
Setting: Ten community pharmacies in Alberta for recruitment and follow-up, engaging both patients and family physicians
- participating pharmacists will have additional prescribing authorization. For pharmacists not having additional prescribing authorization, we will facilitate their application as done in the rural RxACTION study.
Recruitment: Pharmacists will systematically identify potential candidates by inviting all patients with type 2 diabetes receiving oral hypoglycemic medications to check their HbA1c using a point of care test. HbA1c is going to be measured in the pharmacy. The patient has to sign the first stage consent form in order to get his/her HbA1c measured. After signing the consent form, the patient's HbA1c will be measured using a digital meter which requires a blood spot which will be gained by pricking the patient's fingertip. If the result of HbA1c test is normal the patient will be given his/her result and told to keep up the good work. If the result of HbA1c test is high (7.5-11 %) and the patient meets the other inclusion criteria for the study the patient will be asked if he/she wants to participate in the study. If the patient agrees on participating in the study he/she will be asked to sign the second stage consent form. After signing the consent form the patient will be started on insulin glargine at bedtime and will be taught how to use the insulin pen. If HbA1c is > 11% the patient will be assessed by the study investigators, treatment recommendations will be checked and will be referred to his/her family physician.
Follow-up: Patients will be followed at 2, 4, 8, 14, 20, and 26 weeks to capture adverse events, adherence to the insulin regimen, fasting blood sugars (measured by the patient), insulin dose and titration. HbA1c will be measured at baseline and then at week 14 visit and week 26. Interim telephone follow-up may be performed at the discretion of the pharmacist investigator, however telephone follow-up cannot be used for 2 consecutive visits, nor for week 14 or 26 visits. Fasting glucose will be measured at the discretion of the pharmacist and patients will monitor their blood glucose at home and record in a standard patient diary.
After each follow up study the pharmacists is going to inform the patient's family physician if there were any changes in the patient's treatment regimen and also about the results of any tests conducted.
One year after the final follow up visit, the pharmacy is going to receive a phone call from the study investigators to check if the patient is still taking insulin.
- Conditions
- Type 2 Diabetes
- Being tested
- Insulin glargine
- Keywords
- HbA1c, Multicentre before-after design, Glycemic control, Community pharmacists
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargineDrug
Also called Lantus
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in HbA1c from baseline to week 26
The change of the patients' HbA1c between the baseline and the 26 week visits
Measured: 6 months
Secondary outcomes (6)
Quality of life and patient satisfaction.
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)
Measured: 6 months
Proportion of patients achieving the target HbA1c
Proportion of patients achieving HbA1c of ≤7.0% during follow-up
Measured: 6 months
Type and degree of dosage changes in oral hypoglycemic agents
The type and the degree of changes in the oral hypoglycemic dosing regimen
Measured: 6 months
Persistence on insulin glargine
Percentage of patients still taking insulin at the end of follow-up
Measured: 6 months
Safety
Number of hypoglycemic episodes; symptomatic confirmed and severe (i.e., Requiring the help from a third party), as defined by the CDA guidelines
Measured: 6 months
Health economic evaluation
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Ross T. Tsuyuki, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335763
- Sponsor's protocol ID
- LANTU_L_05128*
- Acronym
- RxING
- Status last verified
- Aug 2012
- First submitted
- 13 Apr 2011
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26270946Al 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.
PubMed 24068762
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist Intervention for Glycemic Control in The Community (The RxING Study)
- ClinicalTrials.gov ID
- NCT01335763
- Acronym / sponsor ID
- RxING / LANTU_L_05128*
- Conditions
- Type 2 Diabetes
- Keywords
- HbA1c, Multicentre before-after design, Glycemic control, Community pharmacists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Apr 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND/RATIONALE:
Approximately 1.9 million Canadians are living with diabetes. Estimates are that this number will increase by 75% over the next few decades. Glycemic control in patients with type 2 diabetes mellitus is poor, and poorly controlled patients contribute significantly to the cost of primary health care in Canada. 10% of all acute care hospital admissions in 2006 were attributed to diabetes and its complications.
As type 2 diabetes is a progressive disease, most patients with type 2 diabetes will eventually require insulin. In patients who present with type 2 diabetes and a HbA1C over 9%, insulin can be started immediately, however, historically physicians generally perceive their to be patient difficulties in starting insulin therapy.
INSIGHT demonstrated improved glycemic control with addition of insulin glargine to oral hypoglycemic agents in patients with type 2 diabetes. However, physicians are often reluctant to initiate insulin in these patients. In addition, physicians do not have a system to systematically identify potential candidates for insulin add-on therapy
Pharmacists are front line primary care professionals who see patients with diabetes more frequently than family physicians and as such, could systematically and proactively identify patients with type 2 diabetes with poor glycemic control as a public health approach to chronic disease management. This approach has been used successfully by our group in the past with dyslipidemia and hypertension management involving patients with diabetes.
The scope of practice for pharmacists is changing, with legislation in Alberta (and soon other provinces) allowing pharmacists to prescribe Schedule I medications and order laboratory tests. As such, there is an opportunity to provide greater access, convenience and improved glycemic control by engaging community pharmacists and their patients.
PRIMARY OBJECTIVE: To determine the effect of a community pharmacist prescribing intervention on glycemic control in patients with poorly controlled type 2 diabetes.
SECONDARY OBJECTIVES:
- To determine the effects of pharmacist-directed diabetes care focusing on glycemic control on:
- patient satisfaction
- quality of life
- dosage changes of oral agents
- persistence on insulin glargine and the end of follow-up
- hypoglycemic episodes
- To conduct a health economic assessment of the costs and benefits of the intervention
METHODS:
Design: multicentre pragmatic before-after design trial
Setting: Ten community pharmacies in Alberta for recruitment and follow-up, engaging both patients and family physicians
- participating pharmacists will have additional prescribing authorization. For pharmacists not having additional prescribing authorization, we will facilitate their application as done in the rural RxACTION study.
Recruitment: Pharmacists will systematically identify potential candidates by inviting all patients with type 2 diabetes receiving oral hypoglycemic medications to check their HbA1c using a point of care test. HbA1c is going to be measured in the pharmacy. The patient has to sign the first stage consent form in order to get his/her HbA1c measured. After signing the consent form, the patient's HbA1c will be measured using a digital meter which requires a blood spot which will be gained by pricking the patient's fingertip. If the result of HbA1c test is normal the patient will be given his/her result and told to keep up the good work. If the result of HbA1c test is high (7.5-11 %) and the patient meets the other inclusion criteria for the study the patient will be asked if he/she wants to participate in the study. If the patient agrees on participating in the study he/she will be asked to sign the second stage consent form. After signing the consent form the patient will be started on insulin glargine at bedtime and will be taught how to use the insulin pen. If HbA1c is > 11% the patient will be assessed by the study investigators, treatment recommendations will be checked and will be referred to his/her family physician.
Follow-up: Patients will be followed at 2, 4, 8, 14, 20, and 26 weeks to capture adverse events, adherence to the insulin regimen, fasting blood sugars (measured by the patient), insulin dose and titration. HbA1c will be measured at baseline and then at week 14 visit and week 26. Interim telephone follow-up may be performed at the discretion of the pharmacist investigator, however telephone follow-up cannot be used for 2 consecutive visits, nor for week 14 or 26 visits. Fasting glucose will be measured at the discretion of the pharmacist and patients will monitor their blood glucose at home and record in a standard patient diary.
After each follow up study the pharmacists is going to inform the patient's family physician if there were any changes in the patient's treatment regimen and also about the results of any tests conducted.
One year after the final follow up visit, the pharmacy is going to receive a phone call from the study investigators to check if the patient is still taking insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin glargine | Other | Drug: Insulin glargine10 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin glargineAlso: Lantus10 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 |
Primary outcome
The change in HbA1c from baseline to week 26
Time frame: 6 months
The change of the patients' HbA1c between the baseline and the 26 week visits
6 secondary outcomes
Quality of life and patient satisfaction.
Time frame: 6 months
Proportion of patients achieving the target HbA1c
Time frame: 6 months
Type and degree of dosage changes in oral hypoglycemic agents
Time frame: 6 months
Persistence on insulin glargine
Time frame: 6 months
Safety
Time frame: 6 months
Health economic evaluation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
- Derived from this study: PubMed 26270946Al 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.
- Derived from this study: PubMed 24068762Al 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin glargine in people with Type 2 Diabetes, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in HbA1c from baseline to week 26 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01335763, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013; AzTrials last refreshed its copy on 2 Nov 2026.