Type 1 Diabetes (T1D)AHCL & surgeryNCT06947031
Efficacy and Safety of the Minimed 780G® Advanced Hybrid Closed Loop System (AHCL) in Patients With Type 1 Diabetes Undergoing Surgery
An observational study of Type 1 Diabetes (T1D) and Surgery, Day, run by Hospital Universitario San Ignacio at 1 site in Colombia.
Trial summary
An analytical observational study based on a cohort of patients who received training at San Ignacio University Hospital. Glycemic control metrics were compared between the perioperative and postoperative periods and the preoperative period using a paired t test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes (T1D), Surgery, Day
- What is being tested?
- AHCL
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteColombia
- Study dates
- 1 Aug 2023to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with type 1 diabetes users of AHCL undergoing elective and urgent surgery during the study period.
Who may be able to join
None listed.
Who cannot join
- Patients whose pump use was discontinued during the perioperative period. Pregnant patients. Patients without sensor data in the 2 weeks before and after surgery.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Universitario San Ignacio
Bogota, Cundinamarca, 860.015.536-1
About this study
An analytical observational study based on a cohort of patients who received training at San Ignacio University Hospital. Glycemic control metrics were compared between the perioperative and postoperative periods and the preoperative period using a paired t test. Glycemic control metrics were compared between the preoperative, intraoperative, and postoperative periods using a paired t test. Finally, a subgroup analysis was performed based on the type of procedure, percentage of sensor use, and duration of diabetes.
Read the detailed description
Patients using the Minimed 780G device who completed training and clinical follow-up in the Endocrinology Unit of San Ignacio University Hospital. Through the clinical follow-up established by the unit, patients must inform their physicians if they will be undergoing elective surgery or contact the medical team if they require emergency surgery during the recruitment period.
Data Collection Prior to the Surgical Procedure Once enrolled in the study, information about the surgical procedure will be collected, including the type of procedure and approximate duration. Patients will then be asked to upload their data for viewing on the Medtronic Carelink platform https://carelink.minimed.com/app/login. Glucose monitoring data from the 14 days prior to the surgical procedure will be downloaded from this platform for subsequent analysis.
Prior to the Surgical Procedure The downloaded data will be analyzed prior to the surgical procedure. According to standard clinical practice, a %TBR time under range (<54 mg/dL) or %TBR time under range (<70 mg/dL) greater than 4% will be identified, and the target glucose will be increased by 10 mg/dL relative to the previously established value. This is to reduce the risk of perioperative hypoglycemia.
Data Collection After the Surgical Procedure Once the surgical procedure is complete, data on glycemic control will be downloaded again during the surgical period and the following 14 days. The data will be analyzed according to the Consensus for CGM Metrics in Inpatient Clinical Trials published in 2023 in the Journal of Diabetes Science and Technology, presented later in the text. This consensus aims to identify the most important metrics to measure in CGM studies in patients in the hospital setting and recommend target values for these metrics (32).
Once the patient is discharged, they will be contacted to confirm information about the surgical procedure, such as type of anesthesia, duration of surgery, and postoperative complications, whether related to infectious processes or poor glycemic control.
Data Analysis
The specific metrics mentioned in the Consensus for Continuous Glucose Monitoring Metrics in Inpatient Clinical Trials (22) are described below:
- Conditions
- Type 1 Diabetes (T1D), Surgery, Day
- Being tested
- AHCL
- Keywords
- Type 1 diabetes, Advanced Hybrid Closed Loop system, Time in range, surgery
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHCLDevice
The downloaded data will be analyzed prior to the surgical procedure. In accordance with standard clinical practice, a TBR time-under-range % (<54 mg/dL) or TBR time-under-range % (<70 mg/dL) greater than 4% will be identified, and the target glucose will be increased by 10 mg/dL relative to the previously established value. This is intended to reduce the risk of perioperative hypoglycemia.
| Study group | Role | What they receive |
|---|---|---|
| AHCL | AHCL users (Minimed 780G) undergoing elective and emergent surgical procedures during the study period. Receives: Device: AHCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
Time spent in the range of 100 - 180 mg/dl during the surgery
Measured: Duration fo the surgery
Secondary outcomes (2)
Time below range
To determine safety by the percentage of mean time below the 70 mg/dl range (TBR) in the perioperative period of surgical procedures.
Measured: Duration fo the surgery
THRH
To investigate the association between 70-100mg/dl (time at high risk of hypoglycaemia, THRH) and TBR <54mg/dl.
Measured: Duration fo the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Aug 2023
- Primary completion31 Jan 2025
- Study completion30 Apr 2025
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Responsible party
- Sponsor
- Investigators
- Ana M Gómez Medina, Endocrinologyst, Principal investigator, Hospital Universitario San Ignacio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947031
- Sponsor's protocol ID
- FM-CIE-0085-25
- Acronym
- AHCL & surgery
- Status last verified
- Sep 2025
- First submitted
- 21 Apr 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The availability of information is for academic purposes. It is at the discretion of the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Minimed 780G® Advanced Hybrid Closed Loop System (AHCL) in Patients With Type 1 Diabetes Undergoing Surgery
- ClinicalTrials.gov ID
- NCT06947031
- Acronym / sponsor ID
- AHCL & surgery / FM-CIE-0085-25
- Conditions
- Type 1 Diabetes (T1D), Surgery, Day
- Keywords
- Type 1 diabetes, Advanced Hybrid Closed Loop system, Time in range, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 27 Apr 2025 (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.
An analytical observational study based on a cohort of patients who received training at San Ignacio University Hospital. Glycemic control metrics were compared between the perioperative and postoperative periods and the preoperative period using a paired t test. Glycemic control metrics were compared between the preoperative, intraoperative, and postoperative periods using a paired t test. Finally, a subgroup analysis was performed based on the type of procedure, percentage of sensor use, and duration of diabetes.
Detailed description
Patients using the Minimed 780G device who completed training and clinical follow-up in the Endocrinology Unit of San Ignacio University Hospital. Through the clinical follow-up established by the unit, patients must inform their physicians if they will be undergoing elective surgery or contact the medical team if they require emergency surgery during the recruitment period.
Data Collection Prior to the Surgical Procedure Once enrolled in the study, information about the surgical procedure will be collected, including the type of procedure and approximate duration. Patients will then be asked to upload their data for viewing on the Medtronic Carelink platform https://carelink.minimed.com/app/login. Glucose monitoring data from the 14 days prior to the surgical procedure will be downloaded from this platform for subsequent analysis.
Prior to the Surgical Procedure The downloaded data will be analyzed prior to the surgical procedure. According to standard clinical practice, a %TBR time under range (<54 mg/dL) or %TBR time under range (<70 mg/dL) greater than 4% will be identified, and the target glucose will be increased by 10 mg/dL relative to the previously established value. This is to reduce the risk of perioperative hypoglycemia.
Data Collection After the Surgical Procedure Once the surgical procedure is complete, data on glycemic control will be downloaded again during the surgical period and the following 14 days. The data will be analyzed according to the Consensus for CGM Metrics in Inpatient Clinical Trials published in 2023 in the Journal of Diabetes Science and Technology, presented later in the text. This consensus aims to identify the most important metrics to measure in CGM studies in patients in the hospital setting and recommend target values for these metrics (32).
Once the patient is discharged, they will be contacted to confirm information about the surgical procedure, such as type of anesthesia, duration of surgery, and postoperative complications, whether related to infectious processes or poor glycemic control.
Data Analysis
The specific metrics mentioned in the Consensus for Continuous Glucose Monitoring Metrics in Inpatient Clinical Trials (22) are described below:
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AHCL | – | Device: AHCLAHCL users (Minimed 780G) undergoing elective and emergent surgical procedures during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 1 diabetes users of AHCL undergoing elective and urgent surgery during the study period.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients whose pump use was discontinued during the perioperative period. Pregnant patients. Patients without sensor data in the 2 weeks before and after surgery.
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 |
|---|---|---|
| AHCLThe downloaded data will be analyzed prior to the surgical procedure. In accordance with standard clinical practice, a TBR time-under-range % (<54 mg/dL) or TBR time-under-range % (<70 mg/dL) greater than 4% will be identified, and the target glucose will be increased by 10 mg/dL relative to the previously established value. This is intended to reduce the risk of perioperative hypoglycemia. | Device | AHCL |
Primary outcome
Time in range
Time frame: Duration fo the surgery
Time spent in the range of 100 - 180 mg/dl during the surgery
2 secondary outcomes
Time below range
Time frame: Duration fo the surgery
THRH
Time frame: Duration fo the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Undecided. The availability of information is for academic purposes. It is at the discretion of the principal investigator.
Related trials for Type 1 Diabetes (T1D)
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
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. This study is not recruiting at the moment.
Ana M Gómez Medina, Endocrinologyst principal investigator
Hospital Universitario San Ignacio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes (T1D) and Surgery, Day, 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 0 inclusion and 1 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: finished, as of the sponsor's last update on 23 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: Duration fo the surgery). 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 23 Sep 2025.