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Automated Insulin Delivery
Automated Insulin Delivery for Type 1 Diabetes (AIDE T1D Trial)
Phase 4
Waitlist Available
Led By Kellee Miller, PhD
Research Sponsored by Jaeb Center for Health Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks for each arm of the crossover
Awards & highlights
AIDE T1D Trial Summary
This trial will test two different features of a new insulin pump, the High Continuous Low Glucose Suspend (HCL) feature and the Predictive Low Glucose Suspend (PLGS) feature, to see which one works better in controlling blood sugar levels. The trial will last for 36 weeks and will involve training on how to use the study devices, followed by three 12-week periods in which participants will use either the HCL feature, the PLGS feature, or the standard SAP therapy (control). After the last 12-week period, participants will be given the opportunity to use study devices for an additional 12 weeks to assess
Who is the study for?
This trial is for people aged 65 or older with Type 1 Diabetes who manage their own insulin and glucose monitoring, have had diabetes for at least a year, and are willing to use new automated insulin delivery devices. They must not have severe kidney disease, cognitive impairments that affect understanding of the study or device usage, nor a history of severe diabetic complications in the recent past.Check my eligibility
What is being tested?
The AIDE T1D trial tests two features of the Tandem t:slim X2 insulin pump—Hybrid Closed Loop (HCL) and Predictive Low Glucose Suspend (PLGS)—against standard therapy. Participants will switch between these methods over three periods to compare effectiveness and safety in elderly individuals with Type 1 Diabetes.See study design
What are the potential side effects?
Potential side effects may include skin reactions due to adhesive allergy from device wear, low blood sugar events if settings are not adjusted properly, and possible discomfort or infection at the infusion site.
AIDE T1D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks for each arm of the crossover
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks for each arm of the crossover
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CGM Measured Time <70 mg/dL
Secondary outcome measures
Glucose Control
HbA1c
Hyperglycemia
+2 moreOther outcome measures
Patient Reported Questionnaires
AIDE T1D Trial Design
3Treatment groups
Active Control
Group I: Predictive Low-Glucose Insulin Suspension (PLGS)Active Control1 Intervention
The PLGS intervention arm will utilize the Tandom t:slim X2 with Basal-IQ Technology and Dexcom G6 CGM
Group II: Sensor-Augmented Pump (SAP)Active Control1 Intervention
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
Group III: Hybrid Closed Loop Control (HCL)Active Control1 Intervention
The HCL intervention arm will utilize the Tandom t:slim X2 with Control-IQ Technology and Dexcom G6 CGM
Find a Location
Who is running the clinical trial?
Washington State UniversityOTHER
101 Previous Clinical Trials
56,632 Total Patients Enrolled
University of PennsylvaniaOTHER
2,000 Previous Clinical Trials
42,880,006 Total Patients Enrolled
Tandem Diabetes Care, Inc.Industry Sponsor
37 Previous Clinical Trials
5,605 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used PLGS technology or HCL insulin delivery in the last month.You have had type 1 diabetes for at least 1 year.You have severe kidney disease in stage 4 or 5.You are 65 years old or older.Your kidney function test from the past 6 months shows that your kidneys are working well.Your continuous glucose monitor shows that your blood sugar levels are below 70 mg/dL at least 1.5% of the time before starting the study treatment.You need to have at least 240 hours of continuous glucose monitor readings at the end of the initial assessment period.You have had a serious diabetic episode in the past 6 months.You are taking any medication for diabetes other than metformin.You have had allergic reactions to adhesives or skin problems during the initial phase of the trial, or you have experienced problems with a pump or CGM insertions that would make it hard for you to take part in the trial.You have severe memory or thinking problems that could make it hard for you to understand the study or use study devices.Your average blood sugar level (HbA1c) has been less than 10% in the past 6 months.You are comfortable and willing to use a specific ratio of carbohydrates for your mealtime insulin doses.You have been diagnosed with type 1 diabetes by a doctor.You use an insulin pump or take insulin multiple times a day.Criterion: You must be willing to use a certain type of fast-acting insulin that works with the Tandem t:slim X2 pump.
Research Study Groups:
This trial has the following groups:- Group 1: Predictive Low-Glucose Insulin Suspension (PLGS)
- Group 2: Sensor-Augmented Pump (SAP)
- Group 3: Hybrid Closed Loop Control (HCL)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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 more participants being enrolled at this time for the trial?
"According to the clinicaltrials.gov listing, this research is open for enrolment as of April 11th 2022 after being initially posted on September 28th 2020."
Answered by AI
How many testing locations are actively conducting this research?
"Potential enrollees can find the trial at SUNY Upstate in Syracuse, University of Pennsylvania in Philadelphia, and AdventHealth Diabetes Institute in Orlando among 4 other clinical research sites."
Answered by AI
Is Predictive Low-Glucose Insulin Suspension (PLGS) a viable option that carries minimal risk for individuals?
"Based on our evaluation, the safety of Predictive Low-Glucose Insulin Suspension (PLGS) was rated a 3 since this is an approved Phase 4 trial."
Answered by AI
In what quantity has enrollment for this trial been received?
"This clinical trial needs to recruit 90 suitable candidates. Of which, SUNY Upstate in Syracuse and the University of Pennsylvania in Philadelphia are two established sites for this research."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
New York
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
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