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

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Exercise; Type 1 Diabetes (T1D)
• Intervention / Treatment: Other: Temporary target during an anaerobic training session; Other: SmartGuard during an anaerobic training session

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana M Gómez, Endocrinologyst; Phone Number: 2817 +57 5946161; Email: anagomez@javeriana.edu.co
• Study Contact Backup: Name: Diana C Henao, Endocrinologyst; Phone Number: 2817 +57 5946161; Email: d-henao@javeriana.edu.co

Study Locations

• Colombia
  • Bogota D.C.
    • Bogotá, Bogota D.C., Colombia, 111021
      • Hospital Universitario San Ignacio.
      • Contact: Maria M Manrique; Phone Number: 2475 +57 5946161; Email: mmmanrique@husi.org.co
      • Principal Investigator: Ana M Gómez, Endocrinologyst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Temporary Target; Temporary target during an anaerobic training session	Other: Temporary target during an anaerobic training session; Temporary target during an anaerobic training session
Other: SmartGuard; SmartGuard during an anaerobic training session	Other: SmartGuard during an anaerobic training session; SmartGuard during an anaerobic training session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoglycemia <54 mg/dl	Determination and comparison of rates of clinically significant hypoglycemia	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.	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.	30 days

Collaborators and Investigators

• Sponsor: Hospital Universitario San Ignacio

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 20, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Behavior; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Motor Activity
• Other Study ID Numbers: FM-CIE-1333-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For research purposes, the data will be made available to the reader upon request.
• IPD Sharing Access Criteria: For research purposes, the data will be made available to the reader upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes