Type 1 DiabetesELARA-T1DNCT07382856
Effect of Low-intensity Aerobic Regular Activity on Heart Rate Variability in Type 1 Diabetes
A study testing low-intensity physical activity and Intensive insulin therapy in people with Type 1 Diabetes, run by University of Banja Luka at 1 site in Bosnia and Herzegovina.
Trial summary
A monocentric prospective randomized trial included 35 patients with Type 1 diabetes. Participants were randomized into two groups: Group A with the patients who engaged in low-intensity physical activity matching aerobic threshold five days per week over a one-year observation period and Group B with the patients who… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- low-intensity physical activity and Intensive insulin therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 22 Feb 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Type 1Diabetes at least six months prior to study enrollment
- Male or female patients over 18 years
- Willingness to perform physical activity 5 days/week.
- Absence of heavy, chronic microvascular complications.
- Absence of established Cardiovascular neuropathy.
- Absence of established ASCVD.
Who cannot join
- Type 2 Diabetes
- Active engagement in professional sports
- Limb amputation
- Blindness
- Active malignancy
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
University Clinical Centre of the Republic of Srpska
Banja Luka, 78000
About this study
A monocentric prospective randomized trial included 35 patients with Type 1 diabetes. Participants were randomized into two groups: Group A with the patients who engaged in low-intensity physical activity matching aerobic threshold five days per week over a one-year observation period and Group B with the patients who engaged in physical activity less than five days per week. The study included three clinical visits: at baseline, at six months, and at one year. Assessments included cardiopulmonary exercise testing (CPET) and body composition analysis during the baseline visit and at six-month visit, while 24-hour Holter monitoring was conducted at baseline and at the final visit. Biochemical parameters and microvascular complication risk assessments were performed at every visit.
Read the detailed description
The ELARA-T1D study aims to investigate the impact of regular, long-standing low-intensity aerobic physical activity on heart rate variability (HRV) and cardiovascular autonomic neuropathy (CAN) in patients with Type 1 Diabetes Mellitus (T1DM). While physical activity is a cornerstone of diabetes management, fear of hypoglycemia and lack of specific guidelines often prevent patients from engaging in exercise. The mechanisms by which physical activity improves cardiovascular outcomes are not yet fully understood. Intensity matching threshold has been linked to longevity and mitochondrial efficiency, while enhancing capillary density and mitochondrial quality. This study focuses on reducing cardiovascular risk in T1DM through an unstructured low-intensity physical activity five days per week for 30-60 min per exercise, per exercise, performed at the intensity matching aerobic threshold.
This is a randomized, parallel-assignment longitudinal study. Following a screening phase (0-4 months) to verify inclusion/exclusion criteria and baseline laboratory status, eligible participants had been randomized into two groups:
Experimental Group (Group A): Introduction of low-intensity aerobic activity five days per week for 30-60 minutes. The intensity is individually determined via cardiopulmonary exercise testing (CPET) to achieve training zone 2.
Control Group (Group B): Maintenance of low-activity lifestyle (not exceeding 30 minutes, less than five days per week).
The physical activity protocol is monitored using heart rate tracking (Garmin watches) to ensure patients stay within the prescribed intensity zones.
Assessment of glycemic control using the ambulatory glucose profile (APG) was conducted using a Guardian 4 continuous glucose monitoring (CGM) system (Medtronic, Northridge, CA, USA).
The study evaluates the progression of Cardiovascular Autonomic Neuropathy (CAN) using the 24-hour Holter ECG monitoring to assess HRV
The assessment schedule is as follows:
Baseline (Month 0): Laboratory testing (CBC, UACR, HbA1c, BUN, eGFR, AST, ALT, CK, lipid profile), evaluation of microvascular complications, Cardiac ultrasound, HRV assessment ( 24h Holter), cardiopulmonary exercise testing (CPET), evaluation of glycemic control using the ambulatory glucose profile (APG).
Follow-up (Months 6): Repeat laboratory testing, cardiopulmonary exercise testing (CPET) and APG to track changes in cardiovascular fitness and metabolic control.
Final visit (Months 12): Repeat laboratory testing, evaluation of microvascular complications, HRV assessment and APG to track changes in cardiac autonomic function and metabolic control.
In addition, all subjects underwent CT coronary angiography. Long-term follow-up: Continuous monitoring every 6 months up to 60 months to evaluate the long-term sustainability of the intervention's effects on cardiovascular health and chronic vascular complications Objectives The primary goal is to determine if consistent, low-intensity exercise can delay the onset of CAN or to prevent progression of incipient CAN and improve cardiovascular fitness.
- Conditions
- Type 1 Diabetes
- Being tested
- low-intensity physical activity, Intensive insulin therapy
- Keywords
- Type 1 diabetes, Heart rate variability, Low-intensity physical activity
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-intensity physical activityBehavioural
The exercise intervention consists of low-intensity physical activity (brisk walking) lasting 30-60 minutes, performed five times weekly. Participants will maintain a workload corresponding to Training Zone 2 over the course of the one-year follow-up.
Intensive insulin therapyOther
The patients with diabetes type 1 in Control group will be physical active (low-intensity physical activity) less than five days per week (not exceeding 30 minutes per activity).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The exercise group will consist of patients with type 1 diabetes who will perform low-intensity physical activity in the postprandial period five days per week over a one-year observation period. Receives: Behavioral: low-intensity physical activity; Other: Intensive insulin therapy |
| Control group | Active comparator | Type 1 diabetes patients characterized by a sedentary lifestyle, defined as engaging in low-intensity physical activity less than five days per week. Receives: Other: Intensive insulin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate Variability (HRV) parameters.
Assessment of HRV as a marker for Cardiovascular Autonomic Neuropathy (CAN). The measurement tool is a 24-hour Holter ECG monitor. Specific parameters include the Standard Deviation of NN intervals (SDNN) and Root Mean Square of Successive Differences (RMSSD).
Unit of Measure: Milliseconds (ms).
Measured: Twelve months from the baseline.
Secondary outcomes (3)
Change in Peak Oxygen Consumption (VO2 peak)
Evaluation of cardiovascular fitness through maximal cardiopulmonary exercise testing (CPET) Unit of Measure: milliliters per kilogram per minute (ml/kg/min).
Measured: Six months from the baseline.
Change in Time in Range (TIR).
Assessment of glycemic control using the Guardian 4 Continuous Glucose Monitoring (CGM) system. TIR is defined as the percentage of time spent within the glucose range of 3.9-10.0 mmol/L. Unit of Measure: Percentage (%) of time.
Measured: Six and twelve months from the baseline.
Change in Urine Albumin-to-Creatinine Ratio (UACR).
Assessment of renal microvascular function via laboratory urinalysis. Unit of Measure: milligrams per gram (mg/g).
Measured: Six months from the baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start22 Feb 2024
- Primary completion22 Feb 2026
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Banja Luka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382856
- Sponsor's protocol ID
- PAT1D2025
- Acronym
- ELARA-T1D
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in our article (text, tables, figures, appendices) will be shared with researchers to achieve the aims of their approved proposals.
Publications
Alarcon-Gomez J, Chulvi-Medrano I, Martin-Rivera F, Calatayud J. Effect of High-Intensity Interval Training on Quality of Life, Sleep Quality, Exercise Motivation and Enjoyment in Sedentary People with Type 1 Diabetes Mellitus. Int J Environ Res Public Health. 2021 Nov 30;18(23):12612. doi: 10.3390/ijerph182312612.
PubMed 34886337Bekker I, Kooistra A, van Dijk PR, Lefrandt JD, Veeger NJGM, van Beek AP. The Influence of Exercise and Physical Activity on Autonomic Nervous System Function Measured by Heart Rate Variability in Individuals with Type 1 Diabetes Mellitus-A Systematic Review. Int J Mol Sci. 2025 Jul 23;26(15):7096. doi: 10.3390/ijms26157096.
PubMed 40806227Wilson LC, Peebles KC, Hoye NA, Manning P, Sheat C, Williams MJA, Wilkins GT, Wilson GA, Baldi JC. Resting heart rate variability and exercise capacity in Type 1 diabetes. Physiol Rep. 2017 Apr;5(8):e13248. doi: 10.14814/phy2.13248.
PubMed 28420762Moser O, Zaharieva D, Adolfsson P, Battelino T, Bracken RM, Buckingham BA, Danne T, Davis EA, Dovc K, Forlenza GP, Gillard P, Hofer SE, Hovorka R, Jacobs PJ, Mader JK, Mathieu C, Norgaard K, Oliver NS, O'Neal DN, Pemberton J, Rabasa-Lhoret R, Sherr JL, Sourij H, Tauschmann M, Yardley JE, Riddell MC. The Use of Automated Insulin Delivery around Physical Activity and Exercise in Type 1 Diabetes: A Position Statement of the European Association for the Study of Diabetes (EASD) and the International Society for Pediatric and Adolescent Diabetes (ISPAD). Horm Res Paediatr. 2026;99(3):391-418. doi: 10.1159/000542287. Epub 2024 Dec 10.
PubMed 39657609Riddell MC, Li Z, Gal RL, Calhoun P, Jacobs PG, Clements MA, Martin CK, Doyle Iii FJ, Patton SR, Castle JR, Gillingham MB, Beck RW, Rickels MR; T1DEXI Study Group. Examining the Acute Glycemic Effects of Different Types of Structured Exercise Sessions in Type 1 Diabetes in a Real-World Setting: The Type 1 Diabetes and Exercise Initiative (T1DEXI). Diabetes Care. 2023 Apr 1;46(4):704-713. doi: 10.2337/dc22-1721.
PubMed 36795053Riddell MC, Peters AL. Exercise in adults with type 1 diabetes mellitus. Nat Rev Endocrinol. 2023 Feb;19(2):98-111. doi: 10.1038/s41574-022-00756-6. Epub 2022 Oct 31.
PubMed 36316391Moser O, Zaharieva DP, Adolfsson P, Battelino T, Bracken RM, Buckingham BA, Danne T, Davis EA, Dovc K, Forlenza GP, Gillard P, Hofer SE, Hovorka R, Jacobs PG, Mader JK, Mathieu C, Norgaard K, Oliver NS, O'Neal DN, Pemberton J, Rabasa-Lhoret R, Sherr JL, Sourij H, Tauschmann M, Yardley JE, Riddell MC. The use of automated insulin delivery around physical activity and exercise in type 1 diabetes: a position statement of the European Association for the Study of Diabetes (EASD) and the International Society for Pediatric and Adolescent Diabetes (ISPAD). Diabetologia. 2025 Feb;68(2):255-280. doi: 10.1007/s00125-024-06308-z.
PubMed 39653802Colberg SR, Sigal RJ, Yardley JE, Riddell MC, Dunstan DW, Dempsey PC, Horton ES, Castorino K, Tate DF. Physical Activity/Exercise and Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Nov;39(11):2065-2079. doi: 10.2337/dc16-1728. No abstract available.
PubMed 27926890Maran A, Pavan P, Bonsembiante B, Brugin E, Ermolao A, Avogaro A, Zaccaria M. Continuous glucose monitoring reveals delayed nocturnal hypoglycemia after intermittent high-intensity exercise in nontrained patients with type 1 diabetes. Diabetes Technol Ther. 2010 Oct;12(10):763-8. doi: 10.1089/dia.2010.0038.
PubMed 20807120Yardley JE, Sigal RJ, Kenny GP, Riddell MC, Lovblom LE, Perkins BA. Point accuracy of interstitial continuous glucose monitoring during exercise in type 1 diabetes. Diabetes Technol Ther. 2013 Jan;15(1):46-9. doi: 10.1089/dia.2012.0182. Epub 2012 Nov 8.
PubMed 23137050Tikkanen-Dolenc H, Waden J, Forsblom C, Harjutsalo V, Thorn LM, Saraheimo M, Elonen N, Rosengard-Barlund M, Gordin D, Tikkanen HO, Groop PH; FinnDiane Study Group. Frequent and intensive physical activity reduces risk of cardiovascular events in type 1 diabetes. Diabetologia. 2017 Mar;60(3):574-580. doi: 10.1007/s00125-016-4189-8. Epub 2016 Dec 24.
PubMed 28013340Zebrowska A, Hall B, Kochanska-Dziurowicz A, Janikowska G. The effect of high intensity physical exercise and hypoxia on glycemia, angiogenic biomarkers and cardiorespiratory function in patients with type 1 diabetes. Adv Clin Exp Med. 2018 Feb;27(2):207-216. doi: 10.17219/acem/66354.
PubMed 29521064Rahbar S, Naimi SS, Reza Soltani A, Rahimi A, Akbarzadeh Baghban A, Khorami N. Are Twenty-Four Sessions of Aerobic Exercise Sufficient for Improving Cardiac Parameters in Diabetes Mellitus? A Randomized Controlled Trial. J Tehran Heart Cent. 2018 Apr;13(2):43-51.
PubMed 30483312de Moraes R, Van Bavel D, Gomes MB, Tibirica E. Effects of non-supervised low intensity aerobic excise training on the microvascular endothelial function of patients with type 1 diabetes: a non-pharmacological interventional study. BMC Cardiovasc Disord. 2016 Jan 27;16:23. doi: 10.1186/s12872-016-0191-9.
PubMed 26817606Valletta JJ, Chipperfield AJ, Clough GF, Byrne CD. Daily energy expenditure, cardiorespiratory fitness and glycaemic control in people with type 1 diabetes. PLoS One. 2014 May 14;9(5):e97534. doi: 10.1371/journal.pone.0097534. eCollection 2014.
PubMed 24826899
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-intensity Aerobic Regular Activity on Heart Rate Variability in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07382856
- Acronym / sponsor ID
- ELARA-T1D / PAT1D2025
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Heart rate variability, Low-intensity physical activity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Banja LukaUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 22 Feb 2026 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A monocentric prospective randomized trial included 35 patients with Type 1 diabetes. Participants were randomized into two groups: Group A with the patients who engaged in low-intensity physical activity matching aerobic threshold five days per week over a one-year observation period and Group B with the patients who engaged in physical activity less than five days per week. The study included three clinical visits: at baseline, at six months, and at one year. Assessments included cardiopulmonary exercise testing (CPET) and body composition analysis during the baseline visit and at six-month visit, while 24-hour Holter monitoring was conducted at baseline and at the final visit. Biochemical parameters and microvascular complication risk assessments were performed at every visit.
Detailed description
The ELARA-T1D study aims to investigate the impact of regular, long-standing low-intensity aerobic physical activity on heart rate variability (HRV) and cardiovascular autonomic neuropathy (CAN) in patients with Type 1 Diabetes Mellitus (T1DM). While physical activity is a cornerstone of diabetes management, fear of hypoglycemia and lack of specific guidelines often prevent patients from engaging in exercise. The mechanisms by which physical activity improves cardiovascular outcomes are not yet fully understood. Intensity matching threshold has been linked to longevity and mitochondrial efficiency, while enhancing capillary density and mitochondrial quality. This study focuses on reducing cardiovascular risk in T1DM through an unstructured low-intensity physical activity five days per week for 30-60 min per exercise, per exercise, performed at the intensity matching aerobic threshold.
This is a randomized, parallel-assignment longitudinal study. Following a screening phase (0-4 months) to verify inclusion/exclusion criteria and baseline laboratory status, eligible participants had been randomized into two groups:
Experimental Group (Group A): Introduction of low-intensity aerobic activity five days per week for 30-60 minutes. The intensity is individually determined via cardiopulmonary exercise testing (CPET) to achieve training zone 2.
Control Group (Group B): Maintenance of low-activity lifestyle (not exceeding 30 minutes, less than five days per week).
The physical activity protocol is monitored using heart rate tracking (Garmin watches) to ensure patients stay within the prescribed intensity zones.
Assessment of glycemic control using the ambulatory glucose profile (APG) was conducted using a Guardian 4 continuous glucose monitoring (CGM) system (Medtronic, Northridge, CA, USA).
The study evaluates the progression of Cardiovascular Autonomic Neuropathy (CAN) using the 24-hour Holter ECG monitoring to assess HRV
The assessment schedule is as follows:
Baseline (Month 0): Laboratory testing (CBC, UACR, HbA1c, BUN, eGFR, AST, ALT, CK, lipid profile), evaluation of microvascular complications, Cardiac ultrasound, HRV assessment ( 24h Holter), cardiopulmonary exercise testing (CPET), evaluation of glycemic control using the ambulatory glucose profile (APG).
Follow-up (Months 6): Repeat laboratory testing, cardiopulmonary exercise testing (CPET) and APG to track changes in cardiovascular fitness and metabolic control.
Final visit (Months 12): Repeat laboratory testing, evaluation of microvascular complications, HRV assessment and APG to track changes in cardiac autonomic function and metabolic control.
In addition, all subjects underwent CT coronary angiography. Long-term follow-up: Continuous monitoring every 6 months up to 60 months to evaluate the long-term sustainability of the intervention's effects on cardiovascular health and chronic vascular complications Objectives The primary goal is to determine if consistent, low-intensity exercise can delay the onset of CAN or to prevent progression of incipient CAN and improve cardiovascular fitness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: low-intensity physical activity, Other: Intensive insulin therapyThe exercise group will consist of patients with type 1 diabetes who will perform low-intensity physical activity in the postprandial period five days per week over a one-year observation period. |
| Control group | Active comparator | Other: Intensive insulin therapyType 1 diabetes patients characterized by a sedentary lifestyle, defined as engaging in low-intensity physical activity less than five days per week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of Type 1Diabetes at least six months prior to study enrollment
- Male or female patients over 18 years
- Willingness to perform physical activity 5 days/week.
- Absence of heavy, chronic microvascular complications.
- Absence of established Cardiovascular neuropathy.
Key exclusion criteria (5 listed)
- Type 2 Diabetes
- Active engagement in professional sports
- Limb amputation
- Blindness
- Active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-intensity physical activityThe exercise intervention consists of low-intensity physical activity (brisk walking) lasting 30-60 minutes, performed five times weekly. Participants will maintain a workload corresponding to Training Zone 2 over the course of the one-year follow-up. | Behavioural | Experimental group |
| Intensive insulin therapyThe patients with diabetes type 1 in Control group will be physical active (low-intensity physical activity) less than five days per week (not exceeding 30 minutes per activity). | Other | Control group, Experimental group |
Primary outcome
Change in Heart Rate Variability (HRV) parameters.
Time frame: Twelve months from the baseline.
Assessment of HRV as a marker for Cardiovascular Autonomic Neuropathy (CAN). The measurement tool is a 24-hour Holter ECG monitor. Specific parameters include the Standard Deviation of NN intervals (SDNN) and Root Mean Square of Successive Differences (RMSSD). Unit of Measure: Milliseconds (ms).
3 secondary outcomes
Change in Peak Oxygen Consumption (VO2 peak)
Time frame: Six months from the baseline.
Change in Time in Range (TIR).
Time frame: Six and twelve months from the baseline.
Change in Urine Albumin-to-Creatinine Ratio (UACR).
Time frame: Six months from the baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 34886337Alarcon-Gomez J, Chulvi-Medrano I, Martin-Rivera F, Calatayud J. Effect of High-Intensity Interval Training on Quality of Life, Sleep Quality, Exercise Motivation and Enjoyment in Sedentary People with Type 1 Diabetes Mellitus. Int J Environ Res Public Health. 2021 Nov 30;18(23):12612. doi: 10.3390/ijerph182312612.
- Background: PubMed 40806227Bekker I, Kooistra A, van Dijk PR, Lefrandt JD, Veeger NJGM, van Beek AP. The Influence of Exercise and Physical Activity on Autonomic Nervous System Function Measured by Heart Rate Variability in Individuals with Type 1 Diabetes Mellitus-A Systematic Review. Int J Mol Sci. 2025 Jul 23;26(15):7096. doi: 10.3390/ijms26157096.
- Background: PubMed 28420762Wilson LC, Peebles KC, Hoye NA, Manning P, Sheat C, Williams MJA, Wilkins GT, Wilson GA, Baldi JC. Resting heart rate variability and exercise capacity in Type 1 diabetes. Physiol Rep. 2017 Apr;5(8):e13248. doi: 10.14814/phy2.13248.
- Background: PubMed 39657609Moser O, Zaharieva D, Adolfsson P, Battelino T, Bracken RM, Buckingham BA, Danne T, Davis EA, Dovc K, Forlenza GP, Gillard P, Hofer SE, Hovorka R, Jacobs PJ, Mader JK, Mathieu C, Norgaard K, Oliver NS, O'Neal DN, Pemberton J, Rabasa-Lhoret R, Sherr JL, Sourij H, Tauschmann M, Yardley JE, Riddell MC. The Use of Automated Insulin Delivery around Physical Activity and Exercise in Type 1 Diabetes: A Position Statement of the European Association for the Study of Diabetes (EASD) and the International Society for Pediatric and Adolescent Diabetes (ISPAD). Horm Res Paediatr. 2026;99(3):391-418. doi: 10.1159/000542287. Epub 2024 Dec 10.
- Background: PubMed 36795053Riddell MC, Li Z, Gal RL, Calhoun P, Jacobs PG, Clements MA, Martin CK, Doyle Iii FJ, Patton SR, Castle JR, Gillingham MB, Beck RW, Rickels MR; T1DEXI Study Group. Examining the Acute Glycemic Effects of Different Types of Structured Exercise Sessions in Type 1 Diabetes in a Real-World Setting: The Type 1 Diabetes and Exercise Initiative (T1DEXI). Diabetes Care. 2023 Apr 1;46(4):704-713. doi: 10.2337/dc22-1721.
- Background: PubMed 36316391Riddell MC, Peters AL. Exercise in adults with type 1 diabetes mellitus. Nat Rev Endocrinol. 2023 Feb;19(2):98-111. doi: 10.1038/s41574-022-00756-6. Epub 2022 Oct 31.
- Background: PubMed 39653802Moser O, Zaharieva DP, Adolfsson P, Battelino T, Bracken RM, Buckingham BA, Danne T, Davis EA, Dovc K, Forlenza GP, Gillard P, Hofer SE, Hovorka R, Jacobs PG, Mader JK, Mathieu C, Norgaard K, Oliver NS, O'Neal DN, Pemberton J, Rabasa-Lhoret R, Sherr JL, Sourij H, Tauschmann M, Yardley JE, Riddell MC. The use of automated insulin delivery around physical activity and exercise in type 1 diabetes: a position statement of the European Association for the Study of Diabetes (EASD) and the International Society for Pediatric and Adolescent Diabetes (ISPAD). Diabetologia. 2025 Feb;68(2):255-280. doi: 10.1007/s00125-024-06308-z.
- Background: PubMed 27926890Colberg SR, Sigal RJ, Yardley JE, Riddell MC, Dunstan DW, Dempsey PC, Horton ES, Castorino K, Tate DF. Physical Activity/Exercise and Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Nov;39(11):2065-2079. doi: 10.2337/dc16-1728. No abstract available.
- Background: PubMed 20807120Maran A, Pavan P, Bonsembiante B, Brugin E, Ermolao A, Avogaro A, Zaccaria M. Continuous glucose monitoring reveals delayed nocturnal hypoglycemia after intermittent high-intensity exercise in nontrained patients with type 1 diabetes. Diabetes Technol Ther. 2010 Oct;12(10):763-8. doi: 10.1089/dia.2010.0038.
- Background: PubMed 23137050Yardley JE, Sigal RJ, Kenny GP, Riddell MC, Lovblom LE, Perkins BA. Point accuracy of interstitial continuous glucose monitoring during exercise in type 1 diabetes. Diabetes Technol Ther. 2013 Jan;15(1):46-9. doi: 10.1089/dia.2012.0182. Epub 2012 Nov 8.
- Background: PubMed 28013340Tikkanen-Dolenc H, Waden J, Forsblom C, Harjutsalo V, Thorn LM, Saraheimo M, Elonen N, Rosengard-Barlund M, Gordin D, Tikkanen HO, Groop PH; FinnDiane Study Group. Frequent and intensive physical activity reduces risk of cardiovascular events in type 1 diabetes. Diabetologia. 2017 Mar;60(3):574-580. doi: 10.1007/s00125-016-4189-8. Epub 2016 Dec 24.
- Background: PubMed 29521064Zebrowska A, Hall B, Kochanska-Dziurowicz A, Janikowska G. The effect of high intensity physical exercise and hypoxia on glycemia, angiogenic biomarkers and cardiorespiratory function in patients with type 1 diabetes. Adv Clin Exp Med. 2018 Feb;27(2):207-216. doi: 10.17219/acem/66354.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in our article (text, tables, figures, appendices) will be shared with researchers to achieve the aims of their approved proposals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-intensity physical activity and Intensive insulin therapy in people with Type 1 Diabetes, run by University of Banja Luka at 1 site in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate Variability (HRV) parameters. (time frame: Twelve months from the baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07382856, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.