ClinicalTrials.gg
CompletedNCT01659294DONCMUpdated Jan 27, 2016

Diabetes Outcomes and Nurse Case Manager Study

An interventional study of Nurse Case Management and standard diabetologist care in Type 2 Diabetes, sponsored by BCDiabetes.Ca. Completed at 1 site in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-01-27.

Sponsored by BCDiabetes.Ca · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 756 studies in Diabetes Mellitus, Type 2 with a site in Canada — 82 open to participants now, 112 under way, 25 of them phase 3. Diabetes Mellitus, Type 2 · Canada.

Enrollment
399th of 673
140 · median 227
Started
2012
with 40 others
No phase
204 of 756
39 open now
Registered
309th of 756
by date

Among the 756 studies in Diabetes Mellitus, Type 2 with a site in Canada, this one is the 399th largest by enrollment of the 673 interventional ones that give a count, is one of 41 that started in 2012, is one of 204 with no phase, and was the 309th registered.

Diabetes Mellitus, Type 2

10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Open to participants now

82 of the 756 studies in Diabetes Mellitus, Type 2 with a site in Canada are open now. Recruiting first, the newest first:

77 more — sign in →

All 82 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 882 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.

This study: 18 Years to 90 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 756 studies in Diabetes Mellitus, Type 2 with a site in Canada, or all of them as a file.
02

Study summary

This study will examine whether patients with diabetes who are either 1) newly discharged from hospital or 2) referred to an endocrinologist for management will have better diabetes outcomes when their care is managed primarily by a dedicated case manager (intervention) than by an endocrinologist (standard care) after 6 months of treatment.

Read the detailed description

The study will be a randomized-control trial recruiting patients with type 2 diabetes in a specialty care setting from two sources:

  1. referred by family physicians with inadequate glycemic control likely requiring exogenous insulin therapy
  2. referred by medical staff at Vancouver General Hospital or St. Paul's Hospital during in-patient care \& about to be discharged (Appendix 1).

Patients who meet the inclusion criteria will be randomly assigned into either the NCM group or SC group.

03

Conditions studied

  • Type 2 Diabetes

Keywords

  • Type 2 diabetes
  • outcomes
  • case management
04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Type 2 diabetes
  • A1c > 8.0 or
  • BP > 140/90 or
  • LDL cholesterol > 2.0 (72 mg/dl)

Exclusion criteria

Exclusion Criteria:

  • inability to speak English or to be assisted by somebody fluent in English
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    nurse case management

    nurse case management of diabetic variables

    Behavioral: Nurse Case Management

  • Active comparator
    standard diabetologist care

    standard diabetologist care

    Behavioral: standard diabetologist care

Interventions

  • BehavioralNurse Case Management
  • Behavioralstandard diabetologist care

    routine care by diabetologist \& team

06

What researchers measure

Primary outcomes

  1. A1c

    changes in A1C between NCM vs. SC

    Time frame: 6 months

  2. diabetes distress (DDS)

    changes in diabetes distress between NCM vs. SC. Diabetes Distress (DDS) will be assessed using the 17-item Diabetes Distress Scale (DDS) developed by Polonsky and colleagues. The DDS measures emotional distress and functioning as it relates to living with diabetes. Responses are scored on a 6-point Likert scale (1=no problem to 6=serious problem). A total score is derived by taking the mean of all items. A score of \< 2 indicate low/no distress, 2 - 2.9 indicates moderate distress, and score of ≥ 3 indicates high distress.

    Time frame: 6 months

Secondary outcomes

  1. blood pressure

    changes in BP between NCM vs. SC. Blood pressure will be measured using an Omron Digital Blood Pressure Monitor HEM-907. Two upper arm readings are taken with the average of the two recorded.

    Time frame: 6 months

  2. BMI

    changes in BMI between NCM vs. SC. Height and weight will be measured using the Healthometer mechanical eye level upright standard physician scale with attached stadiometer. Body mass index (BMI) are calculated as weight in kilograms divided by height in meters squared.

    Time frame: 6 months

  3. Self-management behaviours

    changes in behaviour habits between NCM vs. SC. Self-management behaviours will be assessed using items from the Summary of Diabetes Self-Care Activities Measure-revised (SDSCA-R).This instrument measures self-care behaviors including diet, exercise, blood sugar testing and foot care. Participants are asked to report the number of days in the past week (range 0-7 days) in which he/she performed specific self-care practices. Greater number of days indicates better self-management.

    Time frame: 6 months

  4. Medication adherence

    changes in medication adherence between NCM vs. SC. Medication adherence will be assessed using the 4-item Moriskyscale that assesses beliefs and behaviors associated with taking medications.Responses are scored on a dichotomous scale: 0=no and 1=yes. A total score is calculated by adding up all items with lower scored indicating better adherence.

    Time frame: 6 months

  5. Patient motivation

    change in patient motivation between NCM vs. SC. motivation will be measured by the 13-item Patient Activation Measure which assesses participants' self-reported knowledge, skills, and confidence an individual has when managing his/her own health.

    Time frame: 6 months

  6. Diabetes-specific Social Support

    change in diabetes-specific social support between NCM vs. SC Diabetes-specific Social Support will be assessed with a 4-item scale developed by Tang et al. that measures amount of support and satisfaction with support from family, friends and the health care team.

    Time frame: 6 months

  7. Depressive Symptoms Severity

    change in depressive symptoms between NCM vs. SC Depressive Symptom Severity will be assessed using the 9-item PRIME-MD Patient Health Questionnaire (PHQ-9)

    Time frame: 6 months

07

Study locations

1 site
  • Bcdiabetes.Ca
    Vancouver, British Columbia V6R 1B6, Canada
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2012, a primary completion of Feb 2015 and a completion of Feb 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2012
First posted
Aug 7, 2012
Start
Aug 2012
Primary completionActual
Feb 2015
CompletionActual
Feb 2015
Last update
Jan 27, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01659294
Lead sponsor
BCDiabetes.Ca
Collaborators
Sanofi
Responsible party
Tom Elliott (PI, BCDiabetes.Ca) — Principal investigator
First posted
Aug 7, 2012
Start date
Aug 2012
Primary completion
Feb 2015
Completion
Feb 2015
Last update
Jan 27, 2016

Study contacts

Tom Elliott, MBBS
principal investigator · University of British Columbia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Start the discussion