Clinical Research Directory

The Effect of Light Therapy on Cellular Energy and Oxidative Stress in Healthy Adults and Type 1 Diabetic Patients

The goal of this clinical trial is to evaluate the effects of low-level light therapy on cellular energy and oxidative stress in healthy adults and patients with Type 1 diabetes. The main questions it aims to answer are: Does light therapy change adenosine triphosphate (ATP) levels and cytochrome c oxidase activity in blood cells? How does the intervention affect oxidative stress markers, specifically glutathione and malondialdehyde concentrations? Researchers will compare blood samples collected before the light therapy to those collected afterward to see if the intervention alters mitochondrial function. Researchers will also compare the responses of healthy volunteers to those of diabetic patients. Participants will: Provide a baseline blood sample. Receive red and near-infrared light exposure (660 nm and 850 nm) on their arms for 10 to 20 minutes using a therapy pad. Provide a final blood sample immediately after the light exposure.

CBTi for the Treatment of Insomnia in Type 1 Diabetes

The goal of this study is to learn if treating insomnia with a therapy intervention in people with type 1 diabetes will help to better control sugar levels, sleep, and quality of life. The questions this study aims to answer include: Will this intervention help the insomnia symptoms? Will obtaining better sleep aid in the control of diabetes through measures like sugar levels? Will the intervention help with quality of life factors like mood and fatigue? Researchers will compare participants receiving the therapy intervention for sleep with those in the "healthy living" intervention to see if the outcomes are different based on the treatment. Participants in the therapy intervention group will: * meet virtually with a therapist for 8 sessions via Zoom. Once a week for the first 4 weeks and then every other week for the last 4 sessions. Participants in the healthy living group will: * receive weekly health education emails * receive brief weekly calls from a coach to answer any questions Participants, regardless of intervention, over the 12 week study period will: * monitor their sleep for 2 weeks through a sleep-monitoring watch * share their continuous glucose monitoring data throughout the study * answer questionnaires prior to the intervention, halfway through the intervention and then after the intervention * attend 3 in person office visits

HOME-AHCL: Home-Based Implementation of an Advanced Hybrid Closed-Loop System With Telemonitoring in Type 1 Diabetes

The goal of this prospective, single-arm observational study is to characterise a home-based setup and telemonitoring care model for an advanced hybrid closed-loop insulin pump system (Tandem Control-IQ) in adults with type 1 diabetes. The study characterises safety, glycaemic outcomes, direct healthcare costs, and impact on quality of life and user experience over 12 months. The main research questions are: * What is the safety profile of initiating the insulin pump system at home, measured by the percentage of sensor time spent below 54 mg/dL at 12 months? * What longitudinal changes in glycaemic metrics (such as Time in Range) are observed within the cohort following home-based initiation? * What changes in quality of life, technology satisfaction and healthcare experience are observed during follow-up? * What are the direct healthcare costs and resource utilization patterns associated with this care pathway from a public healthcare system perspective? Participants will: * Complete an online technical training course prior to system activation. * Receive a home visit from a specialised nurse to configure and start the insulin pump system. * Have their continuous glucose monitoring data reviewed remotely every 14 days by the nursing team to manage automated clinical alerts. * Attend scheduled clinical follow-up assessments at 1, 3, 6, and 12 months. * Complete questionnaires assessing quality of life, patient experience, and device satisfaction.

Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App

The goal of this controlled pre-post-trial is to test the Accu-Chek SmartGuide continuous glucose monitoring (CGM) system and whether its predictive features provide additional benefits for adults with type 1 diabetes or insulin- treated type 2 diabetes. The main questions this study aims to answer are: * Does using the Accu-Chek SmartGuide together with the Predict App change participants' fear of hypoglycemia? * Does the Predict App affect other psychological and behavioral outcomes, such as sleep quality, confidence in preventing hypoglycemia, diabetes- related distress, and diabetes empowerment? * Does the use of the predictive features affect glucose levels and the way participants use and respond to CGM alarms and trend information? Participants will use the Accu-Chek SmartGuide for 6 weeks. During the first 2 weeks, participants will use the CGM system without the predictive features. During the following 4 weeks, participants will use the system together with the Accu-Chek SmartGuide Predict App. Participants will complete online questionnaires at two time points (after 2 and after 6 weeks) and answer short questions twice a day through a smartphone app during the first 2 weeks and the last 2 weeks of the study. CGM data will be collected throughout the study. A subgroup of 10 participants will also be invited to take part in an online interview about their experiences with the predictive features.

Type 1 Diabetes and Diabetes Distress

The goal of this clinical trial is to reduce diabetes distress in emerging adults (18-35 years) with type 1 diabetes and moderate-to-severe diabetes distress. The expectation is that a group-based psychological intervention (ACTnow) will not only reduce diabetes distress but also improve psychological well-being and glycemic outcomes. The intervention involves a multidisciplinary team, including nurses, psychologists, and physicians, and is designed in a format that can easily be integrated into future standard care. The main research questions are: * Does a group-based psychological intervention reduce diabetes distress? * Does a group-based psychological intervention improve psychological well-being and glycemic outcomes? Researchers will compare the group-based psychological intervention (arm 1) with a waitlist control group, which will receive the intervention after three months (arm 2). Participants will first attend a virtual screening interview with a psychologist or nurse to identify if they are eligible to participate in the study. After randomization, the intervention group receives six bi-weekly sessions, each lasting two hours, led by a psychologist and nurse. Each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion.

Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease

Powerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50/50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD.

Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery

The Medtrum TouchCare Nano system with the APGO algorithm is the only patch pump-based automated insulin delivery system available in the Czech Republic. However, until now, no prospective clinical study has evaluated its efficacy and safety under real-world conditions. The RENEW study is the first to address this topic.

FinnDiane LifeOne Study - Impact of Ageing on People With Type 1 Diabetes

Healthy aging refers to functional ability that enables well-being in older individuals. The focus thus shifts from chronological age to functional capacity and the individual's own experience of well-being. Type 1 diabetes is a chronic condition characterized by elevated blood glucose levels, which increases the risk of cardiovascular diseases and premature death. However, the life expectancy of individuals with type 1 diabetes has significantly improved due to advances in diabetes care. There is limited research on aging with type 1 diabetes, and this study is at the forefront of addressing this gap by examining aging-and especially healthy aging-in type 1 diabetes from multiple perspectives. The goals are to investigate how individuals with type 1 diabetes age and what their functional capacity is compared to individuals without insulin-treated diabetes. The other aim is to identify factors in midlife that predict healthy aging in people with type 1 diabetes.