Patient-Oriented Research Clinical Trials

The Innovations in Type-1 Diabetes (iT1D) Goal-Directed Program is currently conducting six clinical trials with a team of 13 principal investigators and co-investigators from three provinces – Ontario, Quebec and Manitoba – investigating innovative therapies to treat and improve the lives of those living with T1D.  The Program co-leads are Dr. Bruce Perkins (University of Toronto) and Dr. Peter Senior (University of Alberta). These studies include patient-oriented research studies evaluating new therapies in diabetic neuropathy, artificial pancreas, adjunct drugs and immunotherapies.

This year the iT1D Research Program was able to participate in a ‘first of its kind’ CIHR SPOR Innovative Clinical Trial (iCT) multi-year operating grant competition, with funding matched by the JDRF.   This competition not only focussed on designing innovative clinical trials to reduce the burden of continual self-management of persons with T1D, but also had a large emphasis on patient engagement in designing these trials with outcomes that will be accessible, manageable and directly applicable to their direct health concerns.  Of the eight applications that went forward in this competition, three were funded to a maximum of $3,000,000 over 4 years.

Diabetes Action Canada co-investigators Dr. Gillian Booth and Dr. Remi Rhabasa-Lhoret were among the awardees, as well as Dr. Farid Mahmud from the Can-SOLVE CKD SPOR Network.


Diabetes Action Canada Supported Studies

  • Effect of SGLT2 Inhibition on Improving the Glycemic Performance of Single and Dual-Hormone Artificial Pancreas Configuration 

PI: Bruce Perkins

The purpose of this study is to identify the feasibility and efficacy of combined SGLT2 inhibition therapy and artificial pancreas treatment using quantitative outcome measures and questionnaires in subjects with Type 1 diabetes. The outcome measures will determine the effects of these interventions on cardio-metabolic risk factors and prevention of hypoglycemia in men and women with Type 1 diabetes. The randomized control trial design includes an open-label approach using the SGLT2 inhibitor empagliflozin. Short and longer term effects on reducing cardio-metabolic risk will be measured.

  • Topical Pirenzepine for Treatment of Neuropathy in Type 1 Diabetes

PI: Paul Fernyhough

Use pirenzepine to treat, via topical delivery, a small cohort of individuals with Type 2 diabetes exhibiting distal loss of nerve fibers, or intraepidermal nerve fiber (IENF) loss, and determine if treatment can increase levels of IENF at the treatment site.  This is a small scale proof of concept study in individuals with Type 2 diabetes with moderate neuropathy.  The study design follows a published clinical trial by Dr. A. VInik (Boyd-AL et al, 2010, Diab, Metab Syn & Obes) showing efficacy of topical topiramate against lower limb IENF loss in individuals with Type 2 diabetes and moderate neuropathy.

  • Vigorous Physical Activity for Glycemic Control in Type 1 Diabetes Trial (VIGOR)

PI: Jon McGavock

Hypoglycemia is the most life-threatening complication that faces persons with Type 1 diabetes (T1D) and is exacerbated by physical activity. Acute exercise trials in persons with T1D have demonstrated that vigorous intensity physical activity (PA) intervals during conventional moderate intensity PA sessions reduce the risk of hypoglycemia in the hours immediately following exercise. The purpose of this study is to identify the effects (benefits and risk) of moderate intensity aerobic exercise in 70 previously sedentary individuals with T1D ages 15 to 45 years.  The hypothesis is that in this group adding vigorous intensity intervals to a standard of care moderate-intensity exercise program (16- week) intervention will reduce the risk of post-exercise hypoglycemia and post-exercise glucose variability .

  • CNS-mediated Effects of Insulin and GLP-1 on Intestinal and Hepatic Lipoprotein Particle Production in Humans

PI: Gary Lewis

The purpose of this study was to determine whether the intra-nasal administration of insulin by direct effect on the central nervous system would affect lipoprotein production in the liver and intestine. The rationale was to determine if this mode of insulin delivery could have added benefits in attenuating hyperlipidemia with the potential of reducing cardiovascular disease. Based on animal models studies, nasal administration of Lispro was expected to reduce intestinal and/or hepatic lipoprotein production.

This study was published in Arteriosclerosis, Thrombosis, and Vascular Biology in 2017: link here 

  • The Effect of DPP-4 Inhibitor Therapy on Renal Sodium Handling and Renal Hemodynamics in Type 2 Diabetes Patients

PI: David Cherney

DPP-4 inhibition therapy reduces glucagon and blood glucose and increases renal sodium excretion. A more in-depth understanding of renal physiological effects with DPP-4 inhibition is critical, in view of recent results that suggest increased cardiac heart failure risk.  This study found that DPP-4 inhibition promotes a distal tubular natriuresis in conjunction with increased levels of intact SDF-1α1-67. Because of the distal location of the natriuretic effect, DPP-4 inhibition does not affect tubuloglomerular feedback or impair renal hemodynamic function, findings relevant to using DPP-4 inhibitors for treating type 2 diabetes

This paper was published in Diabetes Care in 2017: link here 

  • Comparison of Dual-Hormone Artificial Pancreas, Single Hormone Artificial Pancreas, and Sensor-Augmented Pump Therapy in Outpatient Settings

PI: Remi Rabasa-Lhoret

Despite advances in insulin analogs, insulin pumps and glucose sensors, most patients with T1D do not achieve glycemic targets and continue to fear hypoglycemia. The creation of an artificial pancreas (AP) is a top priority for those with T1D, based on a priority-setting initiative sponsored by the James Lind Alliance. The team has developed an automated, portable AP using leading-edge insulin pump technology that includes two configurations, one that infuses insulin (single-hormone) alone and another that infuses insulin and the counter-regulatory hormone glucagon (dual-hormone). These APs have 3 components: 1) a continuous glucose sensor; 2) insulin infusion pumps with or without glucagon; and 3) an intelligent dosing algorithm to control insulin and glucagon delivery. The insulin infusion rate and, if needed, intermittent glucagon mini-boluses are based on the glucose sensor readings analyzed by the control algorithm.

JDRF/CIHR SPOR Innovative Clinical Trials

Dr. Booth and her team propose a clinical trial testing a novel electronic delivery of health care and related support services to people living with T1D in addition to usual care including frequent, brief virtual visits with their diabetes care team to share and discuss blood glucose patterns, diabetes self-management, coping strategies, personalized goals and action plans.  This intervention will also have structured online educational courses, tools and supports. These virtual visits will use videoconferencing technology that can be securely accessed free of charge from any personal device (PC, tablet, smart phone),

Dr. Rhabasa-Lhoret and his team will examine better strategies to reduce episodes of hypoglycemia.  This includes an online educational strategy to help patients wearing medical devices to monitor blood glucose levels in real time to optimize functionality of these devices.  This study has also developed a peer-to-peer discussion forum to offer social support and personal strategies to reducing hypoglycemia.

  Adolescent Type 1 diabetes Treatment with EMPaglifozin for hyperglycemia & hyperfilTration Trial, "ATTEMPT" Trial

Dr. Farid and his team are examining the effects of a group of medications, called sodium glucose co-transporter 2 inhibitors (SGLT2i) in teens with T1D.  These medications have previous evidence of success in adults with T2D to improve diabetes control and prevent long-term kidney and heart issues due to high blood glucose levels.

All of these studies were co-developed with patients and directly address the concerns articulated by those living with T1D.  Diabetes Action Canada is thrilled to be collaborating with each of these investigators. As research synergies and new collaborations emerge, Diabetes Action Canada is designing a digital health platform to support these research studies.  In particular, the Innovations in the T1D Goal-Directed Program will be forming a Steering Committee to establish a framework for planning and implementing a T1D Registry to assist in implementation of these clinical trials.  The core purpose of the T1D Registry is to facilitate timely and effective recruitment of subjects to clinical trials, while enhancing communication with individuals living with T1D on current clinical trials and how to participate.

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