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Insulin Pump
AHCL System for Type 1 Diabetes
N/A
Waitlist Available
Research Sponsored by Medtronic Diabetes
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-month study period
Awards & highlights
Study Summary
This trial is to study the safety of the Advanced Hybrid Closed Loop (AHCL) system in people with type 1 diabetes.
Who is the study for?
This trial is for people aged 7-75 with Type 1 Diabetes who've been on pump therapy for at least 6 months. They must be willing to wear the AHCL system continuously, perform daily blood glucose tests and sensor calibrations, and have a caregiver available if needed. Excluded are those with recent severe diabetes complications, certain drug abuses, or specific medical conditions.Check my eligibility
What is being tested?
The study evaluates the safety of the Advanced Hybrid Closed Loop (AHCL) insulin pump system in managing Type 1 Diabetes in both adults and children. Participants will use this technology throughout the study to see how well it helps control their blood sugar levels.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include skin irritation from device adhesives, hypoglycemia (low blood sugar), hyperglycemia (high blood sugar), or other typical risks associated with insulin pump therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-month study period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-month study period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in HbA1c
Change in Percentage of Euglycemia
Secondary outcome measures
Change in Percent of Time in Hypoglycemic Range (<70 mg/dL)
Number of Diabetic Ketoacidosis (DKA) Event
Number of Severe Hypoglycemic Event
Trial Design
1Treatment groups
Experimental Treatment
Group I: Subjects 7-75 years of ageExperimental Treatment1 Intervention
Subjects who have been diagnosed with type 1 diabetes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AHCL insulin pump system
2019
N/A
~290
Find a Location
Who is running the clinical trial?
Medtronic DiabetesLead Sponsor
67 Previous Clinical Trials
9,638 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a serious condition called Diabetic Ketoacidosis (DKA) in the last 6 months.Your blood test shows that your creatinine level is higher than 2 mg/dL.You are currently receiving treatment for hyperthyroidism.You have long-term kidney disease that causes ongoing anemia.You are currently using illegal drugs.You are currently using marijuana in a way that is not allowed.You are currently misusing or taking prescription drugs in a way that is not approved by a doctor.You are currently drinking too much alcohol.You are currently taking certain medications for diabetes, such as Symlin, Victoza, or other specific drugs.Your thyroid hormone levels are within the normal range, or if they are not, your Free T3 is within the normal range and your Free T4 is not too high.You have taken steroid medications by mouth, injection, or IV within the past 8 weeks, or plan to take them during the study.You are between 14 and 75 years old and have been diagnosed with type 1 diabetes for at least 2 years by a qualified medical professional.If you had a heart problem more than a year ago, you need to have had a heart test called an EKG within the last 6 months. If the EKG shows a problem, you can still join the study if a heart doctor says it's okay.Your blood does not have enough red blood cells.You have a problem with the tape sticking to your skin where the sensor needs to be placed.You have had a serious drop in blood sugar levels within the last six months that needed medical help or caused you to lose consciousness or have seizures.You have sickle cell disease or another condition affecting your hemoglobin, or you've had a blood transfusion or received erythropoietin in the last 3 months.You need to take at least 8 units of insulin every day.Your blood sugar level (HbA1c) is less than 10%, as tested by a certified laboratory.You have been diagnosed with adrenal insufficiency.You have an eating disorder like anorexia or bulimia.You are not aware when your blood sugar gets too low, as measured by a questionnaire.You are currently receiving dialysis treatment.You are planning to receive a red blood cell transfusion or erythropoietin while in the study.You have any ongoing skin condition where the sensor needs to be placed.Children between 7 and 13 years old who have been diagnosed with type 1 diabetes for at least 1 year according to their medical records.You have experienced a heart attack, chest pain, heart surgery, stroke, or other serious heart or blood vessel problems within the past year.Your HbA1c level is lower than 10% during the screening visit.You are willing to perform ≥ 4 finger stick blood glucose measurements daily.Your thyroid hormone levels are within the normal range, or if they are outside the normal range, your Free T3 and Free T4 levels are within the lab's normal ranges.Children aged 7-13 years old who have been diagnosed with type 1 diabetes for at least 1 year, as confirmed by medical records or a qualified medical professional.You have been using a pump to manage your condition for more than 6 months before the screening. This includes using a continuous glucose monitor (CGM) along with the pump.You are between 7 and 75 years old when you get checked before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects 7-75 years of age
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities remaining to join this scientific experiment?
"Per clinicaltrials.gov, this particular trial is not currently accepting applicants; the study originated on July 24th 2019 and was most recently modified on March 15th 2022. Nevertheless, there are 370 other trials that can be accessed to find appropriate medical studies for enrollment."
Answered by AI
Does this clinical research involve participants aged 40 and older?
"Patients aged between 7 and 75 can be eligible for entry into this medicinal trial. Meanwhile, there are 155 and 178 trials designed specifically for those below the age of 18 or over 65 respectively."
Answered by AI
What criteria must one meet to participate in this experiment?
"This experiment requires 288 participants aged between 7 and 75 with type 1 diabetes. To be eligible, they must meet additional criteria: perform a minimum of 4 finger pricks daily; adhere to the required sensor calibrations; possess an insulin requirement (Total Daily Dose) greater than or equal 8 units; are already using pump therapy for over 6 months at screening time - regardless if they have experience with CGM technology; those aged between 7-13 years must have had a clinical diagnosis of type 1 diabetes for one year or more which is confirmed via medical records from an authorized individual. Furthermore, there may exist other study specific inclusion requirements that need"
Answered by AI
What is the geographical distribution of this experiment?
"This trial is available for patients at Arkansas Diabetes and Endocrinology Center in Little Rock, SoCal Diabetes in Torrance, Washington, Seattle Children's Hospital and Medical Centre in Seattle, Idaho as well as 17 additional medical sites."
Answered by AI
Who else is applying?
What state do they live in?
California
Texas
How old are they?
18 - 65
What site did they apply to?
Diablo Clinical Research
Texas Endocrinology
Diabetes and Glandular Disease Clinic
What portion of applicants met pre-screening criteria?
Met criteria
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