An interventional study of Basal Insulin Initiation Strategy in Diabetes Mellitus, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2020-12-03.
Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Other
Family Physicians, the subjects of this trial are reluctant to initiate insulin in patients with type 2 diabetes due to a lack of familiarity and comfort with this clinical strategy. This study will test the effectiveness of diabetes specialist consultation support, and community pharmacy insulin initiation support on the insulin prescribing behaviour of family physicians across Canada.
The 2003 Canadian Diabetes Association clinical practice guidelines recommend early and sustained glycemic control targeting an glycosylated hemoglobin (A1C) \< 7%. The guideline target however is not achieved in 50% of patients with type 2 diabetes in the Canadian family practice setting. Family physicians are not comfortable initiating and managing insulin for their patients the Diabetes in Canada Evaluation (DICE) study found that only 12% of the 2473 patients audited were prescribed insulin; 6% insulin alone and 6% in combination. Harris et. al. found 20% of patients prescribed insulin, 15% insulin alone and 5% in combination. A strategy to increase physicians' knowledge, skill and comfort with insulin prescription is needed to better achieve glycemic control for patients with type 2 diabetes in Canada.
Purpose - The purpose of AIM@GP is to increase family physicians clinical experience and comfort with insulin prescription and better achieve glycemic control for patients with type 2 diabetes in Canada.
Primary Objective - To determine the effectiveness of a Basal Insulin Initiation strategy on family physician insulin prescribing behaviour. The strategy, using a multifaceted behaviour facilitation approach, includes diabetes specialist consultation support, and community pharmacy insulin initiation support.
Study Design - The study design is a stratified, parallel group, randomized control effectiveness study. All physicians will attend an insulin education workshop where they will receive a Diabetes Practice Profile and randomly allocated in a 1:1 manner into the intervention or control group.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's enrollment of 154 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 351 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Basal Insulin Initiation Strategy which includes: 1. support by community pharmacist 2. support by diabetes specialist
Other: Basal Insulin Initiation Strategy
The physicians randomized to this group proceeded with their usual practice
This multifaceted intervention consists of (1) Diabetes Specialist Consultation Support which entails specialists and educators providing consultation for insulin initiation and titration for the 12 months following the Workshop. Support will consist of prearranged and scheduled communications to review and advise for the first 2 months and will continue on an ad hoc basis for the remaining 10 months, with communication initiated by the physician (2)Community Pharmacy Insulin Initiation consists of trained community pharmacists providing patient education insulin initiation. Education will consist of one individual teaching session, one hour in duration, to review the insulin prescription protocol, insulin injection method, management of hypoglycemia, and self-monitoring of blood glucose.
Also known as: Support by Specialist and Pharmacist
Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice
Insulin Prescription Rate (IPR) - the number of insulin-eligible patients per 12 months who are prescribed insulin in each family physician (FP) practice (Number of patients per year per FP). The IPR was analyzed using Poisson regression with the intervention group as a class effect and the mean HbA1c at baseline as a covariate.
Time frame: 12 months
Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop
mean A1C of insulin-eligible patient per family physician participant during the post-Workshop period
Time frame: 15 months
Mean Fasting Blood Glucose of Insulin-eligible Patients
mean fasting blood glucose (FBG) of insulin-eligible patient per family physician post-Workshop
Time frame: 15 months
Percent of Insulin-eligible Patients With Intensification of Diabetes Management Per FP Post - Workshop
Percent of insulin-eligible patients with intensification of diabetes management (increase dose of oral anti-diabetes drug (OAD) or insulin, OAD score, the addition of insulin) per FP post - Workshop
Time frame: 12 months
Percentage of Patients at Target (A1C ≤ 7.0%) Per FP
Percentage of patients at target (A1C ≤ 7.0%) per FP at time of the Workshop and post - Workshop
Time frame: 15 months
Percent of Patients at Target (A1C ≤ 6.5%) Per FP
Percent of patients at target (A1C ≤ 6.5%) per FP at time of the Workshop and post - Workshop
Time frame: 15 months
Change in "Insulin Prescription Rate"
change in "Insulin Prescription Rate" from baseline prior to the Workshop to 12 months post - Workshop
Time frame: 12 months
Glycemic Control (A1C) at Insulin Initiation, 3 and 6 Months Post Initiation
Glycemic control (A1C) at insulin initiation, 3 months post initiation and 6 months post initiation for those prescribed insulin per family physician
Time frame: 15 months
Physician Score for Knowledge of Insulin Initiation & Titration
physician score for knowledge of insulin initiation \& titration minimum score of 0 maximum score of 17. The greater the score the greater the knowledge.
Time frame: 12 months
Physician Score for Attitude Towards Insulin Initiation & Titration
physician score for attitude towards insulin initiation \& titration The minimum score is 11 and the maximum is 55 with a lower score indicating the ideal attitude.
Time frame: 12 months
Physician Score for Self-efficacy of Insulin Initiation & Titration
physician score for self-efficacy of insulin initiation \& titration where the minimum value was 10 and the maximum was 50. A value of 50 indicated complete self efficacy to initiate and titrate insulin
Time frame: 12 months
| Milestone | Basal Insulin Strategy | Usual Care |
|---|---|---|
| Started | 75 | 79 |
| Completed | 73 | 78 |
| Not completed | 2 | 1 |
| Withdrew: Did not attend workshop; allocation not | 2 | 1 |
| Milestone | Basal Insulin Strategy | Usual Care |
|---|---|---|
| Started | 73 | 78 |
| Completed | 73 | 78 |
| Not completed | 0 | 0 |
Insulin Prescription Rate (IPR) - the number of insulin-eligible patients per 12 months who are prescribed insulin in each family physician (FP) practice (Number of patients per year per FP). The IPR was analyzed using Poisson regression with the intervention group as a class effect and the mean HbA1c at baseline as a covariate.
| patients per year | Basal Insulin Strategy | Usual Care |
|---|---|---|
| Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice | 2.28 ± 0.27 | 2.29 ± 0.25 |
mean A1C of insulin-eligible patient per family physician participant during the post-Workshop period
| Mean % glycolyslated hemoglobin per FP | Basal Insulin Strategy | Usual Care |
|---|---|---|
| Workshop | 7.12 ± 0.42 | 7.20 ± 0.52 |
| End of Study | 7.09 ± 0.41 | 7.15 ± 0.51 |
mean fasting blood glucose (FBG) of insulin-eligible patient per family physician post-Workshop
| mean mmol/L per physician | Basal Insulin Strategy | Usual Care |
|---|---|---|
| Workshop | 7.86 ± 0.67 | 7.89 ± 0.69 |
| End of Study | 7.78 ± 0.68 | 7.82 ± 0.68 |
Percent of insulin-eligible patients with intensification of diabetes management (increase dose of oral anti-diabetes drug (OAD) or insulin, OAD score, the addition of insulin) per FP post - Workshop
| % of pts with intensification per FP | Basal Insulin Strategy | Usual Care |
|---|---|---|
| Percent of Insulin-eligible Patients With Intensification of Diabetes Management Per FP Post - Workshop | 31.59 ± 14.17 | 32.80 ± 14.91 |
Percentage of patients at target (A1C ≤ 7.0%) per FP at time of the Workshop and post - Workshop
| percentage of patients per physician | Basal Insulin Strategy | Usual Care |
|---|---|---|
| Workshop | 58.4 ± 16.20 | 55.95 ± 15.65 |
| End of Study | 58.68 ± 15.40 | 57.58 ± 16.12 |
Percent of patients at target (A1C ≤ 6.5%) per FP at time of the Workshop and post - Workshop
| percent of patients per physician | Basal Insulin Strategy | Usual Care |
|---|---|---|
| At time of Workshop | 36.76 ± 14.95 | 36.62 ± 12.55 |
| 15 months post Workshop | 36.13 ± 15.06 | 36.61 ± 14.28 |
change in "Insulin Prescription Rate" from baseline prior to the Workshop to 12 months post - Workshop
No measurements were reported for this outcome.
Glycemic control (A1C) at insulin initiation, 3 months post initiation and 6 months post initiation for those prescribed insulin per family physician
| Mean % glycosylated hemoglobin per FP | Basal Insulin Initiation Strategy | Usual Practice |
|---|---|---|
| Initiation | 8.82 ± 1.098 | 9.37 ± 1.354 |
| 3 months post initiation | 8.32 ± 1.24 | 9.05 ± 1.344 |
| 6 months post initiation | 7.97 ± 1.003 | 8.57 ± 1.382 |
physician score for knowledge of insulin initiation \& titration minimum score of 0 maximum score of 17. The greater the score the greater the knowledge.
| units on a scale | Basal Insulin Initiation Strategy | Usual Practice |
|---|---|---|
| Pre-Workshop | 15.5 ± 2.2 | 15.5 ± 2.5 |
| Post-Workshop | 16.3 ± 1.9 | 16.9 ± 1.9 |
physician score for attitude towards insulin initiation \& titration The minimum score is 11 and the maximum is 55 with a lower score indicating the ideal attitude.
| units on a scale | Basal Insulin Initiation Strategy | Usual Practice |
|---|---|---|
| Pre-Workshop | 28.9 ± 4.9 | 29.7 ± 5.3 |
| Post-Workshop | 26.1 ± 4.1 | 27.3 ± 5.3 |
physician score for self-efficacy of insulin initiation \& titration where the minimum value was 10 and the maximum was 50. A value of 50 indicated complete self efficacy to initiate and titrate insulin
| score on a scale | Basal Insulin Initiation Strategy | Usual Practice |
|---|---|---|
| Pre Workshop | 35.8 ± 4.67 | 35.7 ± 3.94 |
| Post Workshop | 40.6 ± 3.73 | 39.6 ± 4.0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Basal Insulin Strategy | — | — | — |
| Usual Care | — | — | — |
Number of physicians randomized
| Age, Continuous(years) | Basal Insulin Strategy | Usual Care | Total |
|---|---|---|---|
| Mean | 51.4 ± 8.81 | 48.2 ± 9.06 | 49.6 ± 9.12 |
| Sex: Female, Male(Participants) | Basal Insulin Strategy | Usual Care | Total |
|---|---|---|---|
| Female | 22 | 20 | 42 |
| Male | 53 | 59 | 112 |
Plan to share: No — There is no plan to make individual participant data available to other researchers
The record gives a start of Jul 2006, a primary completion of Mar 2010 and a completion of Mar 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2020, 10 years 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's →