Type 2 Diabetes Mellitus Clinical Trial
Official title:
Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD): Community-driven Innovations and Strategic Scale-up Toolkits
Context: Indigenous peoples experience higher prevalence rates of diabetes and worse health
outcomes compared to the general population because of a wide array of factors: social
determinants of health, lifestyle, genetic susceptibility, and historic-political and
psycho-social factors. Barriers to care that are unique to First Nations communities
exacerbate the problem with fragmented healthcare, poor chronic disease management,
healthcare staff turnover, and limited, or non-existent, surveillance.
Program: The TransFORmation of IndiGEnous PrimAry HEAlthcare Delivery (FORGE AHEAD) research
program aims to develop and evaluate community-driven, culturally relevant, primary
healthcare models that enhance chronic disease prevention and management in First Nations
communities in Canada. Participants will consist of Indigenous community and clinic team
members that will take part in multiple interrelated projects including community profiling,
readiness consultations, diabetes registry and surveillance, and quality improvement
workshops and action periods.
Design: This mixed-method pre-post observational study will capture: 1) diabetes clinical
process and outcomes measures, 2) details about community-driven innovations, and 3)
knowledge about the experience and cost of attempting to improve primary delivery in
individual Indigenous communities.
Intervention/Instrument: Survey, literature review, 15 month intervention (readiness
consultations, implementation and maintenance of a registry and surveillance system,
community and clinic focused quality improvement workshops), interviews.
Measures: Primary- mean A1C of patients with diabetes (A1C ≥ 8.0% at baseline);
Secondary-clinical process and outcome measures, change in stage of readiness, description of
participation and innovation facilitators and barriers.
Policy Implications: The outcomes of this research program have the potential to
significantly affect future policy decisions pertaining to chronic disease care in First
Nations communities. Policy recommendations will be made to help support Indigenous
communities in adopting successful innovations to help address issues related to diabetes and
other chronic illnesses. The community-driven innovations developed in FORGE AHEAD and the
subsequent policy decisions may enhance chronic disease prevention and management for
Indigenous peoples across the country.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02771093 -
An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus
|
Phase 4 | |
| Completed |
NCT02545842 -
Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
|
Phase 4 | |
| Recruiting |
NCT03436212 -
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.
|
N/A | |
| Completed |
NCT03244800 -
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
|
Phase 2 | |
| Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
| Withdrawn |
NCT02769091 -
A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes
|
Phase 2 | |
| Recruiting |
NCT06065540 -
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
|
Phase 3 | |
| Recruiting |
NCT05008276 -
Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
|
||
| Completed |
NCT04091373 -
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
|
Phase 1 | |
| Completed |
NCT03296800 -
Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT06212778 -
Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.
|
||
| Completed |
NCT05979519 -
Fresh Carts for Mom's to Improve Food Security and Glucose Management
|
N/A | |
| Recruiting |
NCT05579314 -
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
| Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
| Terminated |
NCT03684642 -
Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
|
Phase 3 | |
| Completed |
NCT03248401 -
Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
|
Phase 4 | |
| Completed |
NCT03644134 -
A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns
|
N/A | |
| Completed |
NCT05295160 -
Fasting-Associated Immune-metabolic Remission of Diabetes
|
N/A | |
| Completed |
NCT02836873 -
Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment
|
Phase 3 | |
| Completed |
NCT02252224 -
Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance
|