Type 1 Diabetes (T1D)NCT06728423
Comparison of SmartGuard vs Temp Target in Patients With Type 1 Diabetes Users of Advanced Hybrid Closed Loop System (AHCL) in Anaerobic Physical Activity.
A study testing Temporary target during an anaerobic training session and SmartGuard during an anaerobic training session in people with Type 1 Diabetes (T1D) and Exercise, run by Hospital Universitario San Ignacio at 1 site in Colombia.
Trial summary
Patients meeting the inclusion criteria will be identified. An informed consent form will be completed. Clinical data and baseline CGM will be collected at this appointment. During the session, an attempt will be made to establish a physical activity classification (PA0: inactive, PA1: 1-2 times per week, and PA2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes (T1D), Exercise
- What is being tested?
- Temporary target during an anaerobic training session and SmartGuard during an anaerobic training session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteColombia
- Study dates
- 1 Nov 2025to 30 Nov 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 1 diabetes ≥ 1 year ago
- AHCL users (Minimed 780G) with integrated continuous glucose monitoring
- Use of the device for at least the last 3 months
- Physically active (PA≥1): At least one weekly physical exercise session in the last 6 months.
Who cannot join
- Pregnancy
- Physical or mental inability to exercise
- Contraindication to performing Valsalva maneuvers
- History of osteoarticular disease that prevents exercise
- History of tendinopathies that cause pain or limitation
- History of coronary artery disease
Show all 13Show fewer
- Diabetic ketoacidosis or severe hypoglycemia in the last month
- Evidence of autonomic failure (Unnoticed hypoglycemia given by Clarke 3 or more points Appendix 1) I am concerned because now that I am on a pump, this indication is common as support for the insulin pump.
- Use of beta-blockers or glucocorticoids
- Peripheral arterial disease
- Severe proliferative diabetic retinopathy or non-proliferative diabetic retinopathy
- Severe peripheral neuropathy
- Stage 5 chronic kidney disease on renal replacement therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site
Hospital Universitario San Ignacio.
Bogotá, Bogota D.C., 111021
Maria M Manrique, +57 5946161 ext. 2475, mmmanrique@husi.org.co
Ana M Gómez, Endocrinologyst
About this study
Official title: SmartGuard vs Temp Target in Patients With Type 1 Diabetes Users AHCL in Anaerobic Exercise
Patients meeting the inclusion criteria will be identified. An informed consent form will be completed. Clinical data and baseline CGM will be collected at this appointment. During the session, an attempt will be made to establish a physical activity classification (PA0: inactive, PA1: 1-2 times per week, and PA2: more than twice per week) to determine if the patient is physically active, which is defined as at least 60 minutes of physical activity per week during the past 6 months. In addition, the patient will be asked whether or not they perform strength exercises and how regularly they do so. At the end of the first visit, they will be randomized by an electronically generated numerical sequence using the Randomizer for Clinical Trial Lite application. The patient will be scheduled to attend a supervised exercise session at the Pontificia Universidad Javeriana Sports Training Center.
Participants will have a blood glucose test prior to beginning physical activity. The target for starting exercise is 126-180 mg/dl. If the patient has a value less than 90 mg/dl, 20 grams of carbohydrates will be given; if the value is between 90-126 mg/dl, 10 grams will be given (above the investigators said that for anaerobics it could be from 90 mg/dl). If the value is higher than 200 mg/dl, the correction with rapid insulin is calculated according to your usual management. A new glucose test is performed 15 minutes later to confirm that the patient is within the target range. If the patient is within the target range, exercise is performed. If the reading remains above 200, the exercise session is canceled.
Read more
All participants are in SmartGuard mode on the Minimed 780G system. In the control group, the time target is activated 60 minutes before the activity and turned off 15 minutes after the end of the exercise. Participants randomized to SmartGuard will have no changes in device programming. Glucose measurements will be taken at the beginning and end of the exercise session. In addition, a Hooper Index will be calculated to standardize the patient's rest and recovery prior to the session. The strength training session will begin with a brief 15-minute warm-up emphasizing joint flexibility. The workout will consist of 3 sets of 10 repetitions of the following exercises: leg press, chest press, seated row. The estimated weight at which the exercises will be performed will be 60-80% of the 1-RM calculated for each patient. There will be a 90 second timed rest between each set of exercises. The total duration of the training will be 45 minutes. The strength training session begins with a short 15-minute warm-up focusing on joint flexibility. The workout consists of 3 sets of 10 repetitions of the following exercises: leg press, chest press, seated row. The estimated weight at which the exercises are performed is 60-80% of the 1-RM calculated for each patient. A timed rest of 90 seconds will be provided between each set of exercises. The total duration of the training will be 45 minutes. The parameter used to monitor intensity will correspond to the Borg scale measurement and heart rate monitoring. For each participant, the anthropometric variables will be entered into the application in order to perform the exact calculation of the target maximum heart rate (HR) percentage. The activity begins with a 5-minute warm-up at low intensity (55-65% of maximum HR, Borg 9-11), then 35 minutes at moderate intensity (70-80% of maximum HR, Borg 12-13), and ends with a 5-minute cool-down (maximum HR less than 55%). Alarms are set on the device to maintain the desired intensity. Glucose testing is performed at the beginning and end of the activity.
A 14-day washout period will be carried out, after which the group of patients initially assigned to temporary target activation will perform the same exercise in SmartGuard mode; likewise, the group initially assigned to SmartGuard will do so under temporary target mode. For this second session, the same procedure and recommendations already mentioned will be carried out.
CGM data will be collected through integrated continuous glucose monitoring, which downloads the information to the Carelink portal and is accessed online.
- Conditions
- Type 1 Diabetes (T1D), Exercise
- Being tested
- Temporary target during an anaerobic training session, SmartGuard during an anaerobic training session
- 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.
Temporary target during an anaerobic training sessionOther
Temporary target during an anaerobic training session
SmartGuard during an anaerobic training sessionOther
SmartGuard during an anaerobic training session
| Study group | Role | What they receive |
|---|---|---|
| Temporary Target | Other | Temporary target during an anaerobic training session Receives: Other: Temporary target during an anaerobic training session |
| SmartGuard | Other | SmartGuard during an anaerobic training session Receives: Other: SmartGuard during an anaerobic training session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
To compare the difference in glycemic control (TIR and GMI) and safety (TBR and hypoglycemic events) of time-based target activation versus SmartGuard mode in type 1 diabetic patients using the MiniMed 780G during anaerobic exercise.
Measured: 30 days
Secondary outcomes (3)
Hypoglycemia <54 mg/dl
Determination and comparison of rates of clinically significant hypoglycemia
Measured: 30 days
Time in range according phases
Compare the percentage of time in range in the immediate, early, and late phases of the strength exercise.
Measured: 30 days
Time Below Range <70 mg/dl.
Compare the percentage of time below range in the immediate, early, and late phases of the strength exercise.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Nov 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728423
- Sponsor's protocol ID
- FM-CIE-1333-23
- Status last verified
- Sep 2025
- First submitted
- 6 Dec 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: For research purposes, the data will be made available to the reader upon request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmartGuard vs Temp Target in Patients With Type 1 Diabetes Users AHCL in Anaerobic Exercise
- ClinicalTrials.gov ID
- NCT06728423
- Acronym / sponsor ID
- FM-CIE-1333-23
- Conditions
- Type 1 Diabetes (T1D), Exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 11 Dec 2024 (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.
Patients meeting the inclusion criteria will be identified. An informed consent form will be completed. Clinical data and baseline CGM will be collected at this appointment. During the session, an attempt will be made to establish a physical activity classification (PA0: inactive, PA1: 1-2 times per week, and PA2: more than twice per week) to determine if the patient is physically active, which is defined as at least 60 minutes of physical activity per week during the past 6 months. In addition, the patient will be asked whether or not they perform strength exercises and how regularly they do so. At the end of the first visit, they will be randomized by an electronically generated numerical sequence using the Randomizer for Clinical Trial Lite application. The patient will be scheduled to attend a supervised exercise session at the Pontificia Universidad Javeriana Sports Training Center.
Participants will have a blood glucose test prior to beginning physical activity. The target for starting exercise is 126-180 mg/dl. If the patient has a value less than 90 mg/dl, 20 grams of carbohydrates will be given; if the value is between 90-126 mg/dl, 10 grams will be given (above the investigators said that for anaerobics it could be from 90 mg/dl). If the value is higher than 200 mg/dl, the correction with rapid insulin is calculated according to your usual management. A new glucose test is performed 15 minutes later to confirm that the patient is within the target range. If the patient is within the target range, exercise is performed. If the reading remains above 200, the exercise session is canceled.
All participants are in SmartGuard mode on the Minimed 780G system. In the control group, the time target is activated 60 minutes before the activity and turned off 15 minutes after the end of the exercise. Participants randomized to SmartGuard will have no changes in device programming. Glucose measurements will be taken at the beginning and end of the exercise session. In addition, a Hooper Index will be calculated to standardize the patient's rest and recovery prior to the session. The strength training session will begin with a brief 15-minute warm-up emphasizing joint flexibility. The workout will consist of 3 sets of 10 repetitions of the following exercises: leg press, chest press, seated row. The estimated weight at which the exercises will be performed will be 60-80% of the 1-RM calculated for each patient. There will be a 90 second timed rest between each set of exercises. The total duration of the training will be 45 minutes. The strength training session begins with a short 15-minute warm-up focusing on joint flexibility. The workout consists of 3 sets of 10 repetitions of the following exercises: leg press, chest press, seated row. The estimated weight at which the exercises are performed is 60-80% of the 1-RM calculated for each patient. A timed rest of 90 seconds will be provided between each set of exercises. The total duration of the training will be 45 minutes. The parameter used to monitor intensity will correspond to the Borg scale measurement and heart rate monitoring. For each participant, the anthropometric variables will be entered into the application in order to perform the exact calculation of the target maximum heart rate (HR) percentage. The activity begins with a 5-minute warm-up at low intensity (55-65% of maximum HR, Borg 9-11), then 35 minutes at moderate intensity (70-80% of maximum HR, Borg 12-13), and ends with a 5-minute cool-down (maximum HR less than 55%). Alarms are set on the device to maintain the desired intensity. Glucose testing is performed at the beginning and end of the activity.
A 14-day washout period will be carried out, after which the group of patients initially assigned to temporary target activation will perform the same exercise in SmartGuard mode; likewise, the group initially assigned to SmartGuard will do so under temporary target mode. For this second session, the same procedure and recommendations already mentioned will be carried out.
CGM data will be collected through integrated continuous glucose monitoring, which downloads the information to the Carelink portal and is accessed online.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporary Target | Other | Other: Temporary target during an anaerobic training sessionTemporary target during an anaerobic training session |
| SmartGuard | Other | Other: SmartGuard during an anaerobic training sessionSmartGuard during an anaerobic training session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of type 1 diabetes ≥ 1 year ago
- AHCL users (Minimed 780G) with integrated continuous glucose monitoring
- Use of the device for at least the last 3 months
- Physically active (PA≥1): At least one weekly physical exercise session in the last 6 months.
Key exclusion criteria (13 listed)
- Pregnancy
- Physical or mental inability to exercise
- Contraindication to performing Valsalva maneuvers
- History of osteoarticular disease that prevents exercise
- History of tendinopathies that cause pain or limitation
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 |
|---|---|---|
| Temporary target during an anaerobic training sessionTemporary target during an anaerobic training session | Other | Temporary Target |
| SmartGuard during an anaerobic training sessionSmartGuard during an anaerobic training session | Other | SmartGuard |
Primary outcome
Time in range
Time frame: 30 days
To compare the difference in glycemic control (TIR and GMI) and safety (TBR and hypoglycemic events) of time-based target activation versus SmartGuard mode in type 1 diabetic patients using the MiniMed 780G during anaerobic exercise.
3 secondary outcomes
Hypoglycemia <54 mg/dl
Time frame: 30 days
Time in range according phases
Time frame: 30 days
Time Below Range <70 mg/dl.
Time frame: 30 days
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 25 Sep 2025.
- Individual participant dataSharing planned: Yes. For research purposes, the data will be made available to the reader upon request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary target during an anaerobic training session and SmartGuard during an anaerobic training session in people with Type 1 Diabetes (T1D) and Exercise, run by Hospital Universitario San Ignacio at 1 site in Colombia.
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 4 inclusion and 13 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: opening soon, as of the sponsor's last update on 25 Sep 2025. 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 Colombia. 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?
Contact Ana M Gómez, Endocrinologyst (+57 5946161 ext. 2817, anagomez@javeriana.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2025.