Tirzepatide in type 1 diabetes: cardiometabolic effects (TIRTLE)

Cardiovascular disease and its risk factors are prominent issues in type 1 diabetes. There is a need to identify treatments that can address weight, blood sugar management and heart disease risk factors in type 1 diabetes. Tirzepatide is a medication usually used in type 2 diabetes. Whether tirzepatide improves health in type 1 diabetes has not been studied before. The TIRTLE study is a clinical trial studying the effect of tirzepatide on weight and metabolism in adults with type 1 diabetes.

Treatment

The study medication in this trial is given by injection into the skin once a week for 12 weeks. For every 2 participants, 1 will receive the study medication, and 1 will receive placebo. The allocation of medication is done randomly.

Study visits

Volunteers briefly visit the Garvan Institute of Medical Research, Darlinghurst, Sydney, NSW, every week to receive their treatment dose. There are also:

– 2 visits before treatment: visit 1 – 1.5 hours with option for online attendance, visit 2 – up to 3 hours at the Garvan Institute

– 2 visits at the end of treatment, after 12 weeks: visit 3 – 1.5 hours with option for online attendance, visit 4 – up to 3 hours at the Garvan Institute

– In between, volunteers briefly visit the Garvan Institute every week to receive their treatment dose.

Benefits of participation

In addition to improving knowledge about weight management and metabolic health in type 1 diabetes, test results such as body composition measurements will be shared with you.

There is no cost to participate in the study.

Contact

Email: TIRTLE@garvan.org.au

Phone : 0491 731 769

The legal context of collecting, storing and using electronic data obtained from active implanted medical devices used for diabetes in Australia: The consumer experience

There are now many health devices that can be implanted into consumers’ bodies to help with the monitoring their health condition. These devices can communicate health data back to data storage devices where clinicians can review and act accordingly to help maintain consumers’ health. Such advances have raised questions about privacy and consent for the use of consumers health data.

We would like to talk to people who have consented to an implanted active medical device for the management of their diabetes, or have consented to such a device on behalf of another person. The types of implants we are interested in are those that are medically implanted into the user and rely on wireless or Bluetooth connectivity to communicate patient information, such as blood glucose monitors (either connected to an insulin pump or not) that transmit information or data from the implant to an external source (such as the clinical team, the manufacturer or an external app on your phone or computer).

We want to talk with people about their experiences in providing consent to explore whether the existing laws about this topic are sufficient in ensuring informed consent for the collection, storage and future use of the data that is sent and received from those devices.

Key requirements: If you have provided consent for the implantation of an active medical device for the management of your diabetes or consent on behalf of another, we would like to talk with you.

Location: Interviews will be undertaken using Microsoft Teams, so participants can be located anywhere in Australia.

Age: Over 18

Website link: For more information about the study, please contact the student researcher, Rebecca Millar, via email at rmillar@swin.edu.au.

T1D RELAY – Rituximab-pvvr and Abatacept Newly Diagnosed Study

The medicines Rituximab-pvvr and abatacept have both been shown to protect insulin-producing beta cells from immune attack, allowing people with newly diagnosed type 1 diabetes (T1D) to continue producing their own insulin for longer. This trial will look at whether combining these two medicines is better at protecting beta cells from immune attack than rituximab-pvvr alone.

Who can get involved

• Aged between 8 and 45 years.
• Evidence of insulin production, determined by one or more diabetes-related antibodies and detectable C-peptide during a mixed-meal tolerance test (MMTT).
• Up to date with immunisation schedule, including COVID-19 and flu boosters.

Treatment

Participants in this study will receive weekly rituximab-pvvr by intravenous infusion (into a vein in the arm) for four weeks. Participants will then receive weekly injections of abatacept OR placebo (inactive equivalent). Two in every three participants will receive active treatment (abatacept), while one in three will receive placebo. The allocation of medication will be done randomly.

Study visits

Participants will be required to attend 16 visits at a participating clinical centre over a two-year treatment period and a further five visits over a two year follow up period after the treatment. The first four visits for the rituximab-pvvr infusion will take up to eight hours. The remaining visits will vary in duration from one to four hours.

Benefits of participation

All participants in this study will receive active treatment in the form of rituximab-pvvr. Two in every three participants will then receive a second active treatment called abatacept. In addition to the potential for these study medications to delay the progression of T1D, participants will be closely monitored and blood glucose levels managed intensively. This may reduce the risk of long-term complications of T1D, as well as helping remaining beta cells in the pancreas to continue making insulin on their own.

This trial is being undertaken by the JDRF-funded Australasian Type 1 Diabetes Immunotherapy Collaborative (ATIC).

To find out if you are eligible or if you have any questions contact the ATIC team.

STOP-T1D – ATG Prevention Study

Antithymocyte globulin (ATG) is commonly used to prevent transplant rejection. Early research showed that ATG improved blood glucose management and preserved pancreas function in people with recently diagnosed type 1 diabetes (T1D). The STOP-T1D trial will test if ATG can delay or prevent people moving from the from pre-symptomatic stage (Stage 2) to clinically diagnosed T1D (Stage 3).

Stage 2 T1D is when people have two or more autoantibodies and abnormal blood glucose levels. This indicates the immune system has already started attacking the body’s insulin-producing beta cells in the pancreas. These autoantibodies and abnormal blood glucose levels can be detected in a blood test by a health professional. The presence of these autoantibodies increases the risk of progressing to Stage 3 T1D, which is when clinical diagnosis of T1D occurs.

Read more about the 3 stages of T1D development.

Who can get involved

• Aged between 12 and 35 years.
• Be at high risk of progressing to Stage 3 T1D, determined by a positive screening blood test for antibodies and slightly elevated blood glucose.
• Up to date with immunisation schedule, including COVID-19 and flu boosters.
• Other markers indicative of high risk of progression to Stage 3 T1D.

Treatment

The study medication in this trial is given by intravenous infusion (through a vein in the arm) on two consecutive days. For every three participants, two will receive ATG and one will receive placebo. The allocation of medication will be done randomly.

Study visits

The two treatment visits will take six to 10 hours for the infusion and a further two hours for monitoring (8-12 hours in total). Participants will visit the trial site two weeks after the second treatment, then every three to six months for one year. Participants will continue to visit the trial site for monitoring twice a year for up to four years following treatment.

Benefits of participation

In addition to potentially delaying or preventing progression of T1D, benefits to participating in the study include close monitoring and follow up by the research team. If you progress to Stage 3 T1D, the study blood tests will likely show this before any symptoms appear. Early diagnosis and commencement of insulin treatment largely eliminates the risk of a serious condition called diabetic ketoacidosis (DKA).

This trial is being undertaken by the JDRF-funded Australasian Type 1 Diabetes Immunotherapy Collaborative (ATIC).

To find out if you are eligible or if you have any questions contact the ATIC team.

Type1Screen: Screening for early-stage type 1 diabetes in family members

Family members of people diagnosed with type 1 diabetes (T1D) are at an increased risk of developing the condition themselves.  

Type1Screen is a free, JDRF-funded program available to any family members of a person diagnosed with T1D. Testing through Type1Screen can identify the early stages of T1D. Detecting T1D early, before symptoms develop, combined with monitoring, can lead to better long-term health for those with the condition.  

Those who test positive for early-stage T1D will be connected to their closest diabetes centre, and offered the opportunity to enrol in trials of new therapies that can potentially slow or stop the progression of the condition.  

For more information, visit the Type1Screen website, or contact the team by phoning (03) 9342 7063 or emailing Type1Screen@mh.org.au 

Fenofibrate and microvascular events in type 1 diabetic retinopathy (FAME-1-EYE) study

This clinical trial is investigating whether fenofibrate, a drug used to lower cholesterol, can slow or reverse eye damage in adults with type 1 diabetes. Fenofibrate has been shown to slow eye damage in type 2 diabetes, and researchers are now investigating whether the same effect will be seen in T1D.

This study has been approved by the Northern Sydney Local Health District Human Research Ethics Committee.

ANZCTR listing: ACTRN12611000249954

Making friends with yourself: Self-compassion for young people with type 1 diabetes

Our researchers are recruiting young Australians between the ages of 14 and 17, who are diagnosed with Type 1 Diabetes and who are using continuous glucose monitoring. The course consists of 8 x 1.5-hour group sessions.  The first session is scheduled for Wednesday 30th March 2022. Sessions will be delivered via Zoom and take place from 4-5:30pm AWST. 

For more information contact Karina Prentice

Cord reinfusion in diabetes (CORD) pilot study

Cell Care is partnering with The Children’s Hospital at Westmead, New South Wales, in a world–first study investigating the potential of cord blood to prevent or delay the onset of type 1 diabetes in children at high risk of developing the disease.

The CORD study has been approved by the Sydney Children’s Hospitals Network Human Research Ethics Committee.

ANZCTR listing: ACTRN12613000186752