Clinical trial 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. Clinical, Randomized, Crossover Trial.
Official title: SmartGuard vs Temp Target in Patients With Type 1 Diabetes Users AHCL in Anaerobic Exercise
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Type 1 Diabetes (T1D)
Exercise
Lead sponsor: Hospital Universitario San Ignacio
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 we 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time in range
timeFrame: 30 days
Secondary outcomes:
measure: Hypoglycemia <54 mg/dl
timeFrame: 30 days
measure: Time in range according phases
timeFrame: 30 days
measure: Time Below Range <70 mg/dl.
timeFrame: 30 days
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio.
state: Bogota D.C.
Study officials:
References: