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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Ana M Gómez, Endocrinologyst contact

+57 5946161 ext. 2817

anagomez@javeriana.edu.co

Diana C Henao, Endocrinologyst contact

+57 5946161 ext. 2817

d-henao@javeriana.edu.co

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

Other trials in Colombia

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.

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 groups in NCT06728423
Study groupRoleWhat they receive
Temporary TargetOtherTemporary target during an anaerobic training session
Receives: Other: Temporary target during an anaerobic training session
SmartGuardOtherSmartGuard 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.

  1. 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)
  1. Hypoglycemia <54 mg/dl

    Determination and comparison of rates of clinically significant hypoglycemia

    Measured: 30 days

  2. 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

  3. 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.

  1. First posted11 Dec 2024
  2. Study start1 Nov 2025 (estimated)
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

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)
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.

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.

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