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Insulin Delivery System
Hybrid Closed Loop Insulin Delivery System for Type 1 Diabetes (Aim2 Trial)
N/A
Waitlist Available
Led By Michael R Rickels, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical history compatible with type 1 diabetes with disease onset < 40 years of age and insulin dependent for > 10 years
Involvement in intensive diabetes management defined as the use of basal-bolus insulin analog delivery by multi-dose injection (MDI) or continuous subcutaneous insulin infusion (CSII) together with self-monitoring of blood glucose values more than 3 times daily with or without continuous glucose monitoring (CGM) under the direction of an endocrinologist, diabetologist, or diabetes nurse practitioner with at least 3 clinical evaluations during the previous 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 18 months of hybrid closed-loop insulin delivery.
Awards & highlights
Aim2 Trial Summary
This trial will test whether a hybrid closed loop insulin delivery system can help type 1 diabetics avoid low blood sugar levels and regain hypoglycemia awareness. It includes 3 Hyperinsulinemic Clamps done at different intervals to measure improvement.
Who is the study for?
Adults aged 25-70 with type 1 diabetes, diagnosed before age 40 and on insulin for over 10 years. They must have low C-peptide levels, experience hypoglycemia unawareness, and be involved in intensive diabetes management. Excluded are those with abnormal kidney or liver function, high blood pressure, certain medical conditions or treatments that could interfere with the study.Check my eligibility
What is being tested?
The MiniMed 670G system is being tested to see if it can help adults with type 1 diabetes avoid low blood sugar episodes and regain awareness of when their blood sugar drops too low. The trial lasts for about two years including a screening phase and an intervention phase using this hybrid closed loop insulin delivery system.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include skin irritation at the infusion site, possible hypoglycemia or hyperglycemia if the device malfunctions or is used improperly.
Aim2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with type 1 diabetes before 40 and have been on insulin for over 10 years.
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I actively manage my diabetes with insulin and check my blood sugar more than 3 times a day.
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I am between 25 and 70 years old.
Aim2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 18 months of hybrid closed-loop insulin delivery.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 18 months of hybrid closed-loop insulin delivery.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Endogenous Glucose Production
Aim2 Trial Design
1Treatment groups
Experimental Treatment
Group I: Subjects with type 1 diabetes using MiniMed 670G systemExperimental Treatment1 Intervention
Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels < 70 mg/dl.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,078 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,315,056 Total Patients Enrolled
Michael R Rickels, MDPrincipal InvestigatorUniversity of Pennsylvania
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your HbA1c level is higher than 10%.Your hemoglobin level is lower than 11 g/dl if you are a woman, or lower than 12 g/dl if you are a man.My kidney function is below normal levels.I take more than 5 mg of prednisone or an equivalent steroid daily.I am not pregnant, not breastfeeding, and willing to use effective birth control during the study.I was diagnosed with type 1 diabetes before 40 and have been on insulin for over 10 years.You have a condition where you don't realize when your blood sugar is too low, and your test results show that your blood sugar levels can change a lot or are frequently low.I use 1 or more units of insulin per kilogram of my body weight daily.I have diabetic eye disease that hasn't been treated.I have a seizure disorder not caused by very low blood sugar.I haven't taken any diabetes medication except insulin in the last 4 weeks.I actively manage my diabetes with insulin and check my blood sugar more than 3 times a day.You have spent more than 5% of your time with low blood sugar levels (less than 60 mg/dl) over the past 7 days, including at least one episode of low blood sugar overnight.Your blood pressure is very high and not well controlled.My liver tests are higher than normal.I am between 25 and 70 years old.I have an ongoing heart condition.You have a body mass index (BMI) of 30 or higher.I have not received treatment for hypothyroidism, Addison's disease, or Celiac disease.You have very low levels of C-peptide in your blood.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects with type 1 diabetes using MiniMed 670G system
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.
Is this trial still seeking participants?
"The investigation reported on clinicaltrials.gov has ceased recruitment; it was first posted in August 2017 and last amended in October 2022, yet 423 other trials are still open to volunteers."
Answered by AI
Is the age cutoff for this research study below 35 years old?
"This trial necessitates that participants are between 25 and 70 years old. For those under the age of 18, there are 163 corresponding clinical trials; for patients over 65, 210 options exist."
Answered by AI
Am I qualified to participate in this research project?
"Ten adults aged 25 to 70, suffering from hypoglycemia and with a documented history of type 1 diabetes onset before their 40th birthday must be recruited for this research. Additionally, they need to have been insulin-dependent for over 10 years and display an absence of C-peptide (< 0.3 ng/ml). Furthermore, applicants ought to demonstrate involvement in intensive diabetes management as well as evidence of hypoglycemic unawareness (Clarke score 4 or higher) plus one additional criteria such as HYPO score beyond the 90th percentile (1047), marked glycemic lability defined by LI index greater than the 90th"
Answered by AI
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