Type 1 Diabetes MellitusNCT03959423

Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System

A study testing AHCL insulin pump system in people with Type 1 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is a Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects. Read more about this study

Who is it for?: Ages 7 to 75 years
Conditions the study is for: Type 1 Diabetes Mellitus
What is being tested?: AHCL insulin pump system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 288 participants
Where: 17 sitesUnited States
Study dates: 24 Jul 2019to 27 Oct 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 7 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subject is age 7-75 years at time of Screening
Subjects 14-75 years of age: A clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
Subjects 7-13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis Study-specific inclusion criteria
Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
Subject is willing to perform required sensor calibrations
Subject is willing to wear the system continuously throughout the study

Show all 26Show fewer

Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
Subject has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of Screening visit Note: All HbA1c blood specimens will be sent to and tested by a NGSP certified Central Laboratory. HbA1c testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
Subject has TSH in the normal range OR if the TSH is out of normal reference range the Free T3 is below or within the lab's reference range and Free T4 is within the normal reference range.
Pump therapy for greater than 6 months prior to screening (with or without CGM experience)
Subject must have a companion or caregiver available at night for the duration of the study period who resides (or will live) in in the same building (or home). A companion or caregiver should also be available during exercise challenges in the same building, home or location (if not at home). This requirement may be verified by subject report at screening visit.
Subject willing to upload data from the study pump, must have Internet access and a computer system that meets the requirements for uploading the study pump
If subject has celiac disease, it has been adequately treated as determined by the investigator
Subject is willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount)
Humalog™* (insulin lispro injection)
NovoLog™* (insulin aspart)
Subjects with history of cardiovascular event 1 year or more from the time of screening must have an EKG within 6 months prior to screening or during screening. If subject has an abnormal EKG, participation is allowed if there is clearance from a cardiologist
Subjects with the 3 or more cardiovascular risk factors listed below must have an EKG within 6 months prior to screening or during screening. If subject has an abnormal EKG, participation is allowed if there is clearance from a cardiologist
Cardiovascular risk factors include:
Age >35 years
Type 1 diabetes of >15 years' duration
Presence of any additional risk factor for coronary artery disease
Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria)
Presence of peripheral vascular disease
Presence of autonomic neuropathy
Subjects with history of cardiovascular event 1 year or more from the time of screening must have a stress test within 6 months prior to screening or during run in period. If subject fails stress test, participation is allowed if there is clearance from a cardiologist

Who cannot join

Subject has a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to Screening:
Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization)
Coma
Seizures
Subject has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes
Subject has had Diabetic Ketoacidosis (DKA) in the 6 months prior to Screening.

Show all 31Show fewer

Subject has Hypoglycemia Unawareness, as measured by the Gold questionnaire (Gold, MacLeod et al. 1994) at Screening
Subject is unable to tolerate tape adhesive in the area of sensor placement
Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
Women of child-bearing potential who have a positive pregnancy test at Screening or plan to become pregnant during the course of the study
Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
Subject has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
Subject is being treated for hyperthyroidism at time of Screening
Subject has a diagnosis of adrenal insufficiency
Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of Screening, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study
Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks
Subject is currently abusing illicit drugs
Subject is currently abusing marijuana
Subject is currently abusing prescription drugs
Subject is currently abusing alcohol
Subject is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of Screening
Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
Subject has elective surgery planned that requires general anesthesia during the course of the study
Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of Screening
Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
Subject diagnosed with current eating disorder such as anorexia or bulimia
Subject has been diagnosed with chronic kidney disease that results in chronic anemia
Subject has a hematocrit that is below the normal reference range of lab used.
Subject is on dialysis
Subject has serum creatinine of >2 mg/dL.
Research staff involved with the study.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Barbara Davis Center - Adults
Aurora, Colorado, 80045
Barbara Davis Center - Pediatric
Aurora, Colorado, 80045
Texas Endocrinology
Austin, Texas, 78681
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, 38133
Rocky Mountain Diabetes Center
Idaho Falls, Idaho, 83404
Scripps Whittier Diabetes Institute
La Jolla, California, 92037
Arkansas Diabetes and Endocrinology Center
Little Rock, Arkansas, 72211
International Diabetes Center
Minneapolis, Minnesota, 55416
Yale Diabetes Research Program
New Haven, Connecticut, 06511
Rainier Clinical Research
Renton, Washington, 98057
Southeastern Endocrine
Roswell, Georgia, 30076
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78229
Seattle Children's Hospital and Medical Center
Seattle, Washington, 98105
University of South Florida
Tampa, Florida, 33613
SoCal Diabetes
Torrance, California, 90505
Diablo Clinical Research
Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects

This study is a Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects.

Read the detailed description

The purpose of this study is to evaluate the safety of the Advanced Hybrid Closed Loop system (AHCL) in type 1 diabetes adult and pediatric subjects in a home setting. The main objective in conducting this research is to collect data from patients who use the AHCL system at home, at work, at school and everywhere else. Subjects will use 670G 4.0 system with Guardian Sensor 3 (GS3) during study period, and will be allowed to participate in continued access phase, and use 670G 4.0 system with GS3 and 780G system with Guardian 4 Sensor (G4S).

Conditions: Type 1 Diabetes Mellitus
Being tested: AHCL insulin pump system
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.

AHCL insulin pump systemDevice
670G 4.0 system with GS3; 780G system with G4S (continued access phase);

Study groups in NCT03959423
Study group	Role	What they receive
Subjects 7-75 years of age	Experimental	Subjects who have been diagnosed with type 1 diabetes Receives: Device: AHCL insulin pump system

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1c
The overall mean difference of the change in HbA1c from baseline to end of 3-month Study Period.
Measured: Baseline to End of 3-Month Study Period
Change in Percentage of Euglycemia
The overall mean change in % of time in euglycemia (70-180 mg/dL) from baseline to end of 3-month Study Period will be estimated.
Measured: Baseline to End of 3-Month Study Period

Secondary outcomes (3)

Number of Severe Hypoglycemic Event
Number of severe hypoglycemic events occurred during 3-month Study Period
Measured: 3-month Study Period
Number of Diabetic Ketoacidosis (DKA) Event
Number of Diabetic Ketoacidosis (DKA) event occurred during 3-month Study Period
Measured: 3-month Study Period
Change in Percent of Time in Hypoglycemic Range (<70 mg/dL)
The overall mean change in % of time in hypoglycemic range (<70 mg/dL) from baseline to end of 3-month Study Period will be estimated.
Measured: Baseline to End of 3-Month Study Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jul 201927 Oct 2023

First posted22 May 2019
Study start24 Jul 2019
Primary completion17 Mar 2021
Study completion27 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 288 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03959423
Sponsor's protocol ID: CIP321
Status last verified: Dec 2024
First submitted: 20 May 2019
Last updated: 14 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Pihoker C, Shulman DI, Forlenza GP, Kaiserman KB, Sherr JL, Thrasher JR, Buckingham BA, Kipnes MS, Bode BW, Carlson AL, Lee SW, Latif K, Liljenquist DR, Slover RH, Dai Z, Niu F, Shin J, Jonkers RAM, Roy A, Grosman B, Vella M, Cordero TL, McVean J, Rhinehart AS, Vigersky RA; MiniMed AHCL Study Group. Safety and Glycemic Outcomes During the MiniMedTM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2023 Nov;25(11):755-764. doi: 10.1089/dia.2023.0255. Epub 2023 Oct 25.
PubMed 37782145
Cordero TL, Dai Z, Arrieta A, Niu F, Vella M, Shin J, Rhinehart AS, McVean J, Lee SW, Slover RH, Forlenza GP, Shulman DI, Pop-Busui R, Thrasher JR, Kipnes MS, Christiansen MP, Buckingham BA, Pihoker C, Sherr JL, Kaiserman KB, Vigersky RA. Glycemic Outcomes During Early Use of the MiniMed 780G Advanced Hybrid Closed-Loop System with Guardian 4 Sensor. Diabetes Technol Ther. 2023 Sep;25(9):652-658. doi: 10.1089/dia.2023.0123. Epub 2023 Jun 16.
PubMed 37252734
Carlson AL, Sherr JL, Shulman DI, Garg SK, Pop-Busui R, Bode BW, Lilenquist DR, Brazg RL, Kaiserman KB, Kipnes MS, Thrasher JR, Reed JHC, Slover RH, Philis-Tsimikas A, Christiansen M, Grosman B, Roy A, Vella M, Jonkers RAM, Chen X, Shin J, Cordero TL, Lee SW, Rhinehart AS, Vigersky RA. Safety and Glycemic Outcomes During the MiniMed Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Mar;24(3):178-189. doi: 10.1089/dia.2021.0319. Epub 2021 Nov 16.
PubMed 34694909

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
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

All Type 1 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects
ClinicalTrials.gov ID: NCT03959423
Acronym / sponsor ID: CIP321
Conditions: Type 1 Diabetes Mellitus
Study type: Interventional
Recruitment status: Completed
Enrolment: 288 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Study start: 24 Jul 2019 (actual)
Primary completion: 17 Mar 2021 (actual)
Study completion: 27 Oct 2023 (actual)
First posted: 22 May 2019 (actual)
Results: Posted 8 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is a Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Subjects 7-75 years of age	Experimental	Device: AHCL insulin pump systemSubjects who have been diagnosed with type 1 diabetes

Who may qualify

Ages: 7 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (26 listed)

Subject is age 7-75 years at time of Screening
Subjects 14-75 years of age: A clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
Subjects 7-13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis Study-specific inclusion criteria
Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
Subject is willing to perform required sensor calibrations

Key exclusion criteria (31 listed)

Subject has a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to Screening:
Subject has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes
Subject has had Diabetic Ketoacidosis (DKA) in the 6 months prior to Screening.
Subject has Hypoglycemia Unawareness, as measured by the Gold questionnaire (Gold, MacLeod et al. 1994) at Screening
Subject is unable to tolerate tape adhesive in the area of sensor placement

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
AHCL insulin pump system670G 4.0 system with GS3; 780G system with G4S (continued access phase);	Device	Subjects 7-75 years of age

Primary outcome

Change in HbA1c
Time frame: Baseline to End of 3-Month Study Period
The overall mean difference of the change in HbA1c from baseline to end of 3-month Study Period.
Change in Percentage of Euglycemia
Time frame: Baseline to End of 3-Month Study Period
The overall mean change in % of time in euglycemia (70-180 mg/dL) from baseline to end of 3-month Study Period will be estimated.

3 secondary outcomes

Number of Severe Hypoglycemic Event
Time frame: 3-month Study Period
Number of Diabetic Ketoacidosis (DKA) Event
Time frame: 3-month Study Period
Change in Percent of Time in Hypoglycemic Range (<70 mg/dL)
Time frame: Baseline to End of 3-Month Study Period

Results and safety

Results posted to the registry on 8 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects 7-17 Years of Age	160	151
Subjects 18-75 Years of Age	128	124

Primary outcome: Change in HbA1c

Time frame: Baseline to End of 3-Month Study Period. Mean (Standard Deviation). Unit: percentage

Measure	Subjects 7-17 Years of Age n = 160	Subjects 18-75 Years of Age n = 128
Baseline	7.9 (0.9)	7.4 (0.8)
End of Study	7.4 (0.7)	6.9 (0.5)
Change from Baseline to End of Study	-0.5 (0.7)	-0.5 (0.6)

Population analysed: Intention to Treat Population with available data. Twenty-four subjects aged 7-17 and one subject aged 18-75 did not collect A1C at the end of the study period, so 136 subjects aged 7-17 and 127 subjects aged 18-75 were analyzed at end of study period and the change from baseline to end of study period.

Primary outcome: Change in Percentage of Euglycemia

Time frame: Baseline to End of 3-Month Study Period. Mean (Standard Deviation). Unit: percentage

Measure	Subjects 7-17 Years of Age n = 160	Subjects 18-75 Years of Age n = 128
Baseline	59.4 (11.8)	70.5 (9.8)
3 Months Study Period	70.3 (6.5)	75.0 (7.2)
Change from Baseline to 3 Months Study Period	11.0 (9.1)	4.6 (5.9)

Population analysed: Intention to Treat Population

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3-month Study Period and 42-month Continued Access Phase. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects 7-17 Years of Age Study Period	1 of 160 (0.6%)	72 of 160 (45%)	0 of 160
Subjects 18-75 Years of Age Study Period	3 of 128 (2.3%)	44 of 128 (34.4%)	0 of 128
Subjects 7-17 Years of Age Continued Access Phase	3 of 130 (2.3%)	99 of 130 (76.2%)	0 of 130
Subjects 18-75 Years of Age Continued Access Phase	8 of 77 (10.4%)	64 of 77 (83.1%)	0 of 77

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37782145Pihoker C, Shulman DI, Forlenza GP, Kaiserman KB, Sherr JL, Thrasher JR, Buckingham BA, Kipnes MS, Bode BW, Carlson AL, Lee SW, Latif K, Liljenquist DR, Slover RH, Dai Z, Niu F, Shin J, Jonkers RAM, Roy A, Grosman B, Vella M, Cordero TL, McVean J, Rhinehart AS, Vigersky RA; MiniMed AHCL Study Group. Safety and Glycemic Outcomes During the MiniMedTM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2023 Nov;25(11):755-764. doi: 10.1089/dia.2023.0255. Epub 2023 Oct 25.
Derived from this study: PubMed 37252734Cordero TL, Dai Z, Arrieta A, Niu F, Vella M, Shin J, Rhinehart AS, McVean J, Lee SW, Slover RH, Forlenza GP, Shulman DI, Pop-Busui R, Thrasher JR, Kipnes MS, Christiansen MP, Buckingham BA, Pihoker C, Sherr JL, Kaiserman KB, Vigersky RA. Glycemic Outcomes During Early Use of the MiniMed 780G Advanced Hybrid Closed-Loop System with Guardian 4 Sensor. Diabetes Technol Ther. 2023 Sep;25(9):652-658. doi: 10.1089/dia.2023.0123. Epub 2023 Jun 16.
Derived from this study: PubMed 34694909Carlson AL, Sherr JL, Shulman DI, Garg SK, Pop-Busui R, Bode BW, Lilenquist DR, Brazg RL, Kaiserman KB, Kipnes MS, Thrasher JR, Reed JHC, Slover RH, Philis-Tsimikas A, Christiansen M, Grosman B, Roy A, Vella M, Jonkers RAM, Chen X, Shin J, Cordero TL, Lee SW, Rhinehart AS, Vigersky RA. Safety and Glycemic Outcomes During the MiniMed Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Mar;24(3):178-189. doi: 10.1089/dia.2021.0319. Epub 2021 Nov 16.
Individual participant dataSharing planned: No

Related trials for Type 1 Diabetes Mellitus

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
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

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.

The record lists no contact. Use the official record to reach the sponsor.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AHCL insulin pump system in people with Type 1 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 17 sites in United States.

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 26 inclusion and 31 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 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. 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?

Yes. Results are posted in the registry (first posted 8 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in HbA1c (time frame: Baseline to End of 3-Month Study Period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03959423, which also lists 3 linked publications.

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 14 Jan 2025.