None listed
Conditions
Brief summary
The study explores two approaches to diabetes management in Indigenous Australians living in remote communities. Communities will be randomly assigned to either intensive weekly clinic visits, including tirzepatide injections, blood glucose monitoring and other medication oversight, or standard care with usual clinic visits. The primary goal is to determine if the intensive approach improves blood sugar control. Researchers will also assess whether it reduces complications such as kidney, eye, and heart disease. The study aims to provide insight into which strategy offers better health outcomes for this population.
Interventions
This study aims to assess the safety, feasibility, and cost-effectiveness of intensive weekly clinic visits for tirzepatide administration, Blood Glucose (BG) monitoring, and medication administration compared to usual care in Aboriginal and Torres Strait Islander patients with uncontrolled type 2 diabetes.
Intensive Weekly Clinic Visits for Tirzepatide Administration, Blood Glucose Monitoring, and Medication Administration:
The intervention involves 65 weekly clinic visits, each lasting appro
This study aims to assess the safety, feasibility, and cost-effectiveness of intensive weekly clinic visits for tirzepatide administration, Blood Glucose (BG) monitoring, and medication administration compared to usual care in Aboriginal and Torres Strait Islander patients with uncontrolled type 2 diabetes. Intensive Weekly Clinic Visits for Tirzepatide Administration, Blood Glucose Monitoring, and Medication Administration: The intervention involves 65 weekly clinic visits, each lasting approximately 1 hour. These visits will occur once per week throughout the study period. Tirzepatide will be administered by a registered nurse who is trained in diabetes care. Blood Glucose (BG) monitoring will be performed by the same registered nurse during each clinic visit. Medication administration and adjustments will be overseen by an endocrinologist/clinic physician, with the registered nurse administering tirzepatide .The starting dose of tirzepatide will be 2.5 mg, with potential dose adjustments based on patient response and tolerance, up to a maximum of 15 mg . Visits will encompass: Monitoring of clinic attendance records to track patient participation. Reviewing medical records to ensure consistency in medication administration. Conducting periodic patient interviews to assess adherence and identify any barriers to treatment. This study focuses on comparing the outcomes of this intensive management approach with usual care, aiming to provide insights into its potential benefits in improving diabetes control and overall health outcomes in this population.
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Established Type 2 diabetes of at least 6 months duration HbA1c greater than or equal to 7.0 percent Age greater than or equal to 18 years Willing and able to adhere to the study protocol
Exclusion criteria
Type 1 diabetes Heavy alcohol or drug use History of acute or chronic pancreatitis Pregnancy, planned pregnancy or breastfeeding Women of childbearing age not taking adequate contraception BMI greater than 25kg/m2 Severe renal impairment eGFR < 15 ml/min/1.73m2 Unstable cardiovascular disease – recent AMI, unstable angina, stroke, hospitalisation for heart failure in the past 6 months Any comorbid medical or psychological factors that would, on assessment by the investigators, make the person unsuitable for the study. A lack of English literacy that would, on assessment by the investigators, make the person unsuitable for the study. Allergy to tirzepatide
Outcome results
None listed