ClinicalTrials.gg
Not yet recruitingNCT06728423Updated Sep 25, 2025

Comparison of SmartGuard vs Temp Target in Patients With Type 1 Diabetes Users of Advanced Hybrid Closed Loop System (AHCL) in Anaerobic Physical Activity.

An interventional study of Temporary target during an anaerobic training session and SmartGuard during an anaerobic training session in Type 1 Diabetes (T1D) and Exercise, sponsored by Hospital Universitario San Ignacio. Not yet recruiting at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.

Sponsored by Hospital Universitario San Ignacio · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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: 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.

02

Conditions studied

  • Type 1 Diabetes (T1D)
  • Exercise
03

In context

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

This study's planned enrollment of 14 is below the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Hospital Universitario San Ignacio is the lead sponsor of 25 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Physical or mental inability to exercise
  • to performing Valsalva maneuvers
  • History of osteoarticular disease that prevents exercise
  • History of tendinopathies that cause pain or limitation
  • History of coronary artery disease
  • 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
  • Peripheral arterial disease
  • Severe proliferative diabetic retinopathy or non-proliferative diabetic retinopathy
  • Severe peripheral neuropathy
  • Stage 5 chronic kidney disease on renal replacement therapy
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
14 participants (estimated)

Study arms

  • Other
    Temporary Target

    Temporary target during an anaerobic training session

    Other: Temporary target during an anaerobic training session

  • Other
    SmartGuard

    SmartGuard during an anaerobic training session

    Other: SmartGuard during an anaerobic training session

Interventions

  • OtherTemporary target during an anaerobic training session

    Temporary target during an anaerobic training session

  • OtherSmartGuard during an anaerobic training session

    SmartGuard during an anaerobic training session

06

What researchers measure

Primary outcomes

  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.

    Time frame: 30 days

Secondary outcomes

  1. Hypoglycemia <54 mg/dl

    Determination and comparison of rates of clinically significant hypoglycemia

    Time frame: 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.

    Time frame: 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.

    Time frame: 30 days

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — For research purposes, the data will be made available to the reader upon request.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Access criteria: For research purposes, the data will be made available to the reader upon request.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2025; primary completion for Nov 2027, 24 months later.

Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 24 months is above that.

Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 6, 2024
First posted
Dec 11, 2024
StartEst.
Nov 1, 2025
Primary completionEst.
Nov 30, 2027
CompletionEst.
Nov 30, 2027
Last update
Sep 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06728423
Lead sponsor
Hospital Universitario San Ignacio
Responsible party
Sponsor
First posted
Dec 11, 2024
Start date
Nov 1, 2025 (estimated)
Primary completion
Nov 30, 2027 (estimated)
Completion
Nov 30, 2027 (estimated)
Last update
Sep 25, 2025

Study contacts

Ana M Gómez, Endocrinologyst
Contact
anagomez@javeriana.edu.co
+57 5946161 ext. 2817
Diana C Henao, Endocrinologyst
Contact
d-henao@javeriana.edu.co
+57 5946161 ext. 2817

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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