Type 1 DiabetesNCT07550608
Effects of Pre-Exercise Basal Insulin Manipulation on Glucose Dynamics in Females vs. Males With Type 1 Diabetes
A study testing 50% Pre-Exercise Basal Insulin Rate Reduction (BIRR) and Habitual Basal Insulin Rate Maintenance in people with Type 1 Diabetes, run by Naama Constantini at 1 site in Israel.
Trial summary
The Purpose of the Study The purpose of this study is to compare how blood sugar levels change during exercise in men and women with type 1 diabetes (T1D). Researchers want to understand if biological sex affects the risk of low blood sugar (hypoglycemia) during physical activity. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- 50% Pre-Exercise Basal Insulin Rate Reduction (BIRR) and Habitual Basal Insulin Rate Maintenance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Oct 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 45 years.
- Diagnosis of Type 1 Diabetes (T1D) for at least 18 months.
- Current use of an insulin pump (Continuous Subcutaneous Insulin Infusion - CSII) for diabetes management.
- Regular physical activity level, defined as at least 150 minutes of aerobic exercise per week across three or more sessions for at least 4 weeks prior to the study.
- Ability to perform 60 minutes of continuous treadmill running.
- Aerobic fitness level (VO2peak) of ≥ 30 mL·kg-¹·min-¹ for females or ≥ 32 mL·kg-¹·min-¹ for males.
Who cannot join
- Most recent HbA1c > 9.9% (85 mmol/mol).
- C-peptide levels ≥ 0.7 nmol/L.
- Presence of significant diabetes complications (e.g., proliferative retinopathy, nephropathy, or symptomatic neuropathy).
- Use of concomitant medications affecting glucose metabolism other than insulin (e.g., steroids, SGLT2 inhibitors, GLP-1 receptor agonists, or non-selective beta-blockers).
- History of hypoglycemia unawareness.
- Occurrence of severe hypoglycemia resulting in seizure, coma, or hospitalization within the 6 months prior to recruitment.
Show all 11Show fewer
- Adherence to a low-carbohydrate or ketogenic diet (<30 g of carbohydrates per day).
- Current engagement in shift work.
- For female participants: presence of primary or secondary amenorrhea (cessation of menstruation for >12 months).
- Uncontrolled hypertension (Systolic BP > 200 mmHg or Diastolic BP > 110 mmHg).
- Known cardiovascular disease or significant cardiovascular risk factors (e.g., ischemic heart disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pre-Exercise Basal Insulin Manipulation on Glucose Dynamics in Females vs. Males With Type 1 Diabetes: A Cross-Over Study
The Purpose of the Study The purpose of this study is to compare how blood sugar levels change during exercise in men and women with type 1 diabetes (T1D). Researchers want to understand if biological sex affects the risk of low blood sugar (hypoglycemia) during physical activity. Additionally, the study examines whether reducing the background (basal) insulin dose before exercise is effective at keeping blood sugar stable.
Study Population The study includes active adults (men and women) aged 18-45 who have lived with type 1 diabetes for at least 18 months and use an insulin pump.
Read more
What Happens During the Study
Participants complete three laboratory visits:
Visit 1: A fitness test on a treadmill to measure the participant's aerobic capacity.
Visits 2 \& 3: Two 60-minute moderate-intensity exercise sessions on a treadmill.
In one session, participants reduce their basal insulin by 50% starting 90-120 minutes before exercising.
In the other session, they maintain their usual insulin dose.
Researchers measure blood sugar every 10 minutes during exercise and collect blood samples before and after the sessions to monitor hormone levels.
Study Design This is a randomized crossover study, meaning every participant performs both exercise strategies in a random order to serve as their own control.
Read the detailed description
Background and Rationale:
Physical activity is highly recommended for individuals with type 1 diabetes (T1D), but managing blood glucose during exercise remains a significant challenge. A common strategy to prevent exercise-induced hypoglycemia (low blood sugar) is the reduction of the basal insulin infusion rate (BIRR) before starting physical activity. However, most guidelines are based on research conducted primarily in male cohorts. This study aims to address this knowledge gap by characterizing sex differences in glucose dynamics during prolonged moderate-intensity exercise and evaluating the effectiveness of a 50% BIRR strategy in both men and women.
Study Design:
This study follows a prospective, randomized, crossover design. Each participant serves as their own control, completing two distinct experimental exercise sessions in a randomized order to compare different insulin management strategies.
Study Procedures:
Participants complete three separate visits to the laboratory:
Visit 1 (Screening and Preliminary Assessment):
Participants undergo medical screening and a graded exercise test on a motorized treadmill. This test determines maximal aerobic capacity (VO2 peak) and the first ventilatory threshold (VT1). These results are used to set a personalized, moderate exercise intensity for the subsequent sessions.
Visits 2 and 3 (Experimental Exercise Sessions):
Participants perform a 60-minute exercise bout on a treadmill at a moderate intensity (90% of the heart rate at VT1). These sessions are scheduled at least 48 hours apart.
The two experimental conditions are:
INS_RED: Participants reduce their basal insulin infusion rate by 50% starting 90 to 120 minutes before the exercise bout.
INS_FULL: Participants maintain their habitual basal insulin infusion rate without any adjustment.
Standardization and Safety Protocols:
Pre-exercise State: All participants arrive at the lab after a 4-hour fast to minimize the impact of recent meals on blood sugar.
Menstrual Cycle Control: To control for the impact of sex hormones on metabolism, female participants are tested exclusively during the early follicular phase (days 1-7 of the menstrual cycle).
Glucose Monitoring: Capillary blood glucose (CBG) is measured every 10 minutes during the 60-minute exercise period.
Hypoglycemia Management: If blood glucose falls below 70 mg/dL, exercise is paused, and participants are given 16-23 grams of standardized glucose. Exercise is resumed only after blood glucose levels rise above 70 mg/dL.
Data Truncation: For the analysis of glucose dynamics, data is analyzed up to the point of the first hypoglycemic event to accurately reflect the rate of decline.
Scientific Measurements:
Primary Outcome: The mean rate of glucose decline, the incidence of hypoglycemia, and the time taken to reach hypoglycemic thresholds.
Blood Markers: Venous blood samples are collected before and immediately after exercise to measure circulating insulin, glucagon, cortisol, adrenaline, and sex hormones.
Metabolic Assessment: Respiratory gas exchange is measured during exercise to determine the participant's use of carbohydrates and fats for energy (substrate oxidation).
- Conditions
- Type 1 Diabetes
- Being tested
- 50% Pre-Exercise Basal Insulin Rate Reduction (BIRR), Habitual Basal Insulin Rate Maintenance
- Keywords
- type 1 diabetes, basal insulin rate reduction, physical activity, aerobic activity
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50% Pre-Exercise Basal Insulin Rate Reduction (BIRR)Other
Participants are instructed to reduce their habitual basal insulin infusion rate by 50% using their continuous subcutaneous insulin infusion (CSII) pump. This reduction is initiated 90 to 120 minutes prior to the start of the 60-minute moderate-intensity treadmill exercise bout. The intervention is designed to evaluate if this proactive reduction mitigates the risk of exercise-induced hypoglycemia in both male and female recreational athletes with type 1 diabetes.
Habitual Basal Insulin Rate MaintenanceOther
Participants perform a 60-minute moderate-intensity treadmill exercise bout while maintaining their full habitual basal insulin infusion rate as programmed in their CSII pump. No adjustments, reductions, or suspensions of the basal rate are made prior to or during the exercise session. This condition serves as the active comparator to evaluate standard glucose dynamics without anticipatory insulin manipulation.
| Study group | Role | What they receive |
|---|---|---|
| 50% Basal Insulin Reduction (INS_RED) | Other | Participants perform a 60-minute moderate-intensity treadmill session after reducing their habitual basal insulin infusion rate by 50%. This reduction is initiated 90-120 minutes before the start of exercise. Receives: Other: 50% Pre-Exercise Basal Insulin Rate Reduction (BIRR); Other: Habitual Basal Insulin Rate Maintenance |
| Full Habitual Basal Insulin (INS_FULL) | Other | Participants perform a 60-minute moderate-intensity treadmill session while maintaining their full habitual basal insulin infusion rate (no adjustment made prior to or during exercise). Receives: Other: 50% Pre-Exercise Basal Insulin Rate Reduction (BIRR); Other: Habitual Basal Insulin Rate Maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Rate of Capillary Blood Glucose (CBG) Decline
The average rate at which blood glucose levels decrease during the 60-minute moderate-intensity exercise session, measured in mg/dL per 10 minutes. This metric is used to characterize glucose dynamics and compare the impact of insulin reduction versus full dose across biological sexes.
Measured: During the 60-minute exercise session.
Secondary outcomes (4)
Incidence of Exercise-Induced Hypoglycemia
The number of participants who reach a capillary blood glucose threshold of <70 mg/dL (3.9 mmol/L) during the exercise bout.
Measured: During the 60-minute exercise session.
Time to Onset of Hypoglycemia
The duration (in minutes) from the start of exercise until the first recorded blood glucose measurement below 70 mg/dL.
Measured: During the 60-minute exercise session.
Changes in Plasma Counter-Regulatory Hormone Levels
Changes in concentrations of glucagon, cortisol, and adrenaline from pre-exercise to immediate post-exercise. This assesses the physiological stress and metabolic response to the combined challenge of exercise and insulin manipulation.
Measured: Baseline (pre-exercise) and 60 minutes (immediately post-exercise).
Substrate Utilization (Respiratory Exchange Ratio)
The ratio between carbon dioxide production (VCO2) and oxygen consumption (VO2) measured via breath-by-breath gas exchange. This is used to estimate the relative contribution of carbohydrate and lipid oxidation during exercise.
Measured: Throughout the 60-minute exercise session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start20 Oct 2023
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This randomized, two-period, two-sequence crossover study stratifies participants by biological sex. Participants are randomly assigned to one of two sequences: Sequence A: 60-minute moderate-intensity exercise with a 50% basal insulin reduction (INS\_RED) 90-120 mins pre-exercise, followed by a minimum 48-hour washout, then the same exercise session with the full habitual basal dose (INS\_FULL). Sequence B: 60-minute exercise with the full habitual dose (INS\_FULL), followed by a minimum 48-hour washout, then exercise with a 50% basal reduction (INS\_RED). Randomization: Block randomization within each sex strata ensures an equal distribution of starting conditions. To minimize hormonal influence on glucose metabolism, sessions for female participants are scheduled during the early follicular phase of the menstrual cycle.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naama Constantini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naama Constantini, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550608
- Sponsor's protocol ID
- SZMC - 0272-23
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and confidentiality. Given the small sample size and the detailed nature of the metabolic and clinical data collected, there is a risk of potential re-identification.
Publications
Moser O, Riddell MC, Eckstein ML, Adolfsson P, Rabasa-Lhoret R, van den Boom L, Gillard P, Norgaard K, Oliver NS, Zaharieva DP, Battelino T, de Beaufort C, Bergenstal RM, Buckingham B, Cengiz E, Deeb A, Heise T, Heller S, Kowalski AJ, Leelarathna L, Mathieu C, Stettler C, Tauschmann M, Thabit H, Wilmot EG, Sourij H, Smart CE, Jacobs PG, Bracken RM, Mader JK. Glucose management for exercise using continuous glucose monitoring (CGM) and intermittently scanned CGM (isCGM) systems in type 1 diabetes: position statement of the European Association for the Study of Diabetes (EASD) and of the International Society for Pediatric and Adolescent Diabetes (ISPAD) endorsed by JDRF and supported by the American Diabetes Association (ADA). Pediatr Diabetes. 2020 Dec;21(8):1375-1393. doi: 10.1111/pedi.13105. Epub 2020 Oct 13.
PubMed 33047481Riddell MC, Gallen IW, Smart CE, Taplin CE, Adolfsson P, Lumb AN, Kowalski A, Rabasa-Lhoret R, McCrimmon RJ, Hume C, Annan F, Fournier PA, Graham C, Bode B, Galassetti P, Jones TW, Millan IS, Heise T, Peters AL, Petz A, Laffel LM. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017 May;5(5):377-390. doi: 10.1016/S2213-8587(17)30014-1. Epub 2017 Jan 24.
PubMed 28126459
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-Exercise Basal Insulin Manipulation on Glucose Dynamics in Females vs. Males With Type 1 Diabetes: A Cross-Over Study
- ClinicalTrials.gov ID
- NCT07550608
- Acronym / sponsor ID
- SZMC - 0272-23
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, basal insulin rate reduction, physical activity, aerobic activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Naama ConstantiniUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 24 Apr 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.
The Purpose of the Study The purpose of this study is to compare how blood sugar levels change during exercise in men and women with type 1 diabetes (T1D). Researchers want to understand if biological sex affects the risk of low blood sugar (hypoglycemia) during physical activity. Additionally, the study examines whether reducing the background (basal) insulin dose before exercise is effective at keeping blood sugar stable.
Study Population The study includes active adults (men and women) aged 18-45 who have lived with type 1 diabetes for at least 18 months and use an insulin pump.
What Happens During the Study
Participants complete three laboratory visits:
Visit 1: A fitness test on a treadmill to measure the participant's aerobic capacity.
Visits 2 \& 3: Two 60-minute moderate-intensity exercise sessions on a treadmill.
In one session, participants reduce their basal insulin by 50% starting 90-120 minutes before exercising.
In the other session, they maintain their usual insulin dose.
Researchers measure blood sugar every 10 minutes during exercise and collect blood samples before and after the sessions to monitor hormone levels.
Study Design This is a randomized crossover study, meaning every participant performs both exercise strategies in a random order to serve as their own control.
Detailed description
Background and Rationale:
Physical activity is highly recommended for individuals with type 1 diabetes (T1D), but managing blood glucose during exercise remains a significant challenge. A common strategy to prevent exercise-induced hypoglycemia (low blood sugar) is the reduction of the basal insulin infusion rate (BIRR) before starting physical activity. However, most guidelines are based on research conducted primarily in male cohorts. This study aims to address this knowledge gap by characterizing sex differences in glucose dynamics during prolonged moderate-intensity exercise and evaluating the effectiveness of a 50% BIRR strategy in both men and women.
Study Design:
This study follows a prospective, randomized, crossover design. Each participant serves as their own control, completing two distinct experimental exercise sessions in a randomized order to compare different insulin management strategies.
Study Procedures:
Participants complete three separate visits to the laboratory:
Visit 1 (Screening and Preliminary Assessment):
Participants undergo medical screening and a graded exercise test on a motorized treadmill. This test determines maximal aerobic capacity (VO2 peak) and the first ventilatory threshold (VT1). These results are used to set a personalized, moderate exercise intensity for the subsequent sessions.
Visits 2 and 3 (Experimental Exercise Sessions):
Participants perform a 60-minute exercise bout on a treadmill at a moderate intensity (90% of the heart rate at VT1). These sessions are scheduled at least 48 hours apart.
The two experimental conditions are:
INS_RED: Participants reduce their basal insulin infusion rate by 50% starting 90 to 120 minutes before the exercise bout.
INS_FULL: Participants maintain their habitual basal insulin infusion rate without any adjustment.
Standardization and Safety Protocols:
Pre-exercise State: All participants arrive at the lab after a 4-hour fast to minimize the impact of recent meals on blood sugar.
Menstrual Cycle Control: To control for the impact of sex hormones on metabolism, female participants are tested exclusively during the early follicular phase (days 1-7 of the menstrual cycle).
Glucose Monitoring: Capillary blood glucose (CBG) is measured every 10 minutes during the 60-minute exercise period.
Hypoglycemia Management: If blood glucose falls below 70 mg/dL, exercise is paused, and participants are given 16-23 grams of standardized glucose. Exercise is resumed only after blood glucose levels rise above 70 mg/dL.
Data Truncation: For the analysis of glucose dynamics, data is analyzed up to the point of the first hypoglycemic event to accurately reflect the rate of decline.
Scientific Measurements:
Primary Outcome: The mean rate of glucose decline, the incidence of hypoglycemia, and the time taken to reach hypoglycemic thresholds.
Blood Markers: Venous blood samples are collected before and immediately after exercise to measure circulating insulin, glucagon, cortisol, adrenaline, and sex hormones.
Metabolic Assessment: Respiratory gas exchange is measured during exercise to determine the participant's use of carbohydrates and fats for energy (substrate oxidation).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized, two-period, two-sequence crossover study stratifies participants by biological sex. Participants are randomly assigned to one of two sequences: Sequence A: 60-minute moderate-intensity exercise with a 50% basal insulin reduction (INS_RED) 90-120 mins pre-exercise, followed by a minimum 48-hour washout, then the same exercise session with the full habitual basal dose (INS_FULL). Sequence B: 60-minute exercise with the full habitual dose (INS_FULL), followed by a minimum 48-hour washout, then exercise with a 50% basal reduction (INS_RED). Randomization: Block randomization within each sex strata ensures an equal distribution of starting conditions. To minimize hormonal influence on glucose metabolism, sessions for female participants are scheduled during the early follicular phase of the menstrual cycle.
| Arm | Type | Receives |
|---|---|---|
| 50% Basal Insulin Reduction (INS_RED) | Other | Other: 50% Pre-Exercise Basal Insulin Rate Reduction (BIRR), Other: Habitual Basal Insulin Rate MaintenanceParticipants perform a 60-minute moderate-intensity treadmill session after reducing their habitual basal insulin infusion rate by 50%. This reduction is initiated 90-120 minutes before the start of exercise. |
| Full Habitual Basal Insulin (INS_FULL) | Other | Other: 50% Pre-Exercise Basal Insulin Rate Reduction (BIRR), Other: Habitual Basal Insulin Rate MaintenanceParticipants perform a 60-minute moderate-intensity treadmill session while maintaining their full habitual basal insulin infusion rate (no adjustment made prior to or during exercise). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 45 years.
- Diagnosis of Type 1 Diabetes (T1D) for at least 18 months.
- Current use of an insulin pump (Continuous Subcutaneous Insulin Infusion - CSII) for diabetes management.
- Regular physical activity level, defined as at least 150 minutes of aerobic exercise per week across three or more sessions for at least 4 weeks prior to the study.
- Ability to perform 60 minutes of continuous treadmill running.
Key exclusion criteria (11 listed)
- Most recent HbA1c > 9.9% (85 mmol/mol).
- C-peptide levels ≥ 0.7 nmol/L.
- Presence of significant diabetes complications (e.g., proliferative retinopathy, nephropathy, or symptomatic neuropathy).
- Use of concomitant medications affecting glucose metabolism other than insulin (e.g., steroids, SGLT2 inhibitors, GLP-1 receptor agonists, or non-selective beta-blockers).
- History of hypoglycemia unawareness.
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 |
|---|---|---|
| 50% Pre-Exercise Basal Insulin Rate Reduction (BIRR)Participants are instructed to reduce their habitual basal insulin infusion rate by 50% using their continuous subcutaneous insulin infusion (CSII) pump. This reduction is initiated 90 to 120 minutes prior to the start of the 60-minute moderate-intensity treadmill exercise bout. The intervention is designed to evaluate if this proactive reduction mitigates the risk of exercise-induced hypoglycemia in both male and female recreational athletes with type 1 diabetes. | Other | 50% Basal Insulin Reduction (INS_RED), Full Habitual Basal Insulin (INS_FULL) |
| Habitual Basal Insulin Rate MaintenanceParticipants perform a 60-minute moderate-intensity treadmill exercise bout while maintaining their full habitual basal insulin infusion rate as programmed in their CSII pump. No adjustments, reductions, or suspensions of the basal rate are made prior to or during the exercise session. This condition serves as the active comparator to evaluate standard glucose dynamics without anticipatory insulin manipulation. | Other | 50% Basal Insulin Reduction (INS_RED), Full Habitual Basal Insulin (INS_FULL) |
Primary outcome
Mean Rate of Capillary Blood Glucose (CBG) Decline
Time frame: During the 60-minute exercise session.
The average rate at which blood glucose levels decrease during the 60-minute moderate-intensity exercise session, measured in mg/dL per 10 minutes. This metric is used to characterize glucose dynamics and compare the impact of insulin reduction versus full dose across biological sexes.
4 secondary outcomes
Incidence of Exercise-Induced Hypoglycemia
Time frame: During the 60-minute exercise session.
Time to Onset of Hypoglycemia
Time frame: During the 60-minute exercise session.
Changes in Plasma Counter-Regulatory Hormone Levels
Time frame: Baseline (pre-exercise) and 60 minutes (immediately post-exercise).
Substrate Utilization (Respiratory Exchange Ratio)
Time frame: Throughout the 60-minute exercise session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 33047481Moser O, Riddell MC, Eckstein ML, Adolfsson P, Rabasa-Lhoret R, van den Boom L, Gillard P, Norgaard K, Oliver NS, Zaharieva DP, Battelino T, de Beaufort C, Bergenstal RM, Buckingham B, Cengiz E, Deeb A, Heise T, Heller S, Kowalski AJ, Leelarathna L, Mathieu C, Stettler C, Tauschmann M, Thabit H, Wilmot EG, Sourij H, Smart CE, Jacobs PG, Bracken RM, Mader JK. Glucose management for exercise using continuous glucose monitoring (CGM) and intermittently scanned CGM (isCGM) systems in type 1 diabetes: position statement of the European Association for the Study of Diabetes (EASD) and of the International Society for Pediatric and Adolescent Diabetes (ISPAD) endorsed by JDRF and supported by the American Diabetes Association (ADA). Pediatr Diabetes. 2020 Dec;21(8):1375-1393. doi: 10.1111/pedi.13105. Epub 2020 Oct 13.
- Background: PubMed 28126459Riddell MC, Gallen IW, Smart CE, Taplin CE, Adolfsson P, Lumb AN, Kowalski A, Rabasa-Lhoret R, McCrimmon RJ, Hume C, Annan F, Fournier PA, Graham C, Bode B, Galassetti P, Jones TW, Millan IS, Heise T, Peters AL, Petz A, Laffel LM. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017 May;5(5):377-390. doi: 10.1016/S2213-8587(17)30014-1. Epub 2017 Jan 24.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and confidentiality. Given the small sample size and the detailed nature of the metabolic and clinical data collected, there is a risk of potential re-identification.
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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 50% Pre-Exercise Basal Insulin Rate Reduction (BIRR) and Habitual Basal Insulin Rate Maintenance in people with Type 1 Diabetes, run by Naama Constantini at 1 site in Israel.
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 11 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: finished, as of the sponsor's last update on 30 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean Rate of Capillary Blood Glucose (CBG) Decline (time frame: During the 60-minute exercise session.). 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 NCT07550608, which also lists 2 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 30 Apr 2026.