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Closed-Loop Control System + Web-Based Tool for Type 1 Diabetes (ABC-WIT Trial)
N/A
Recruiting
Led By Sue Brown, MD
Research Sponsored by Sue Brown
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Total daily insulin dose (TDD) at least 10 units per day
Currently using the t:slim X2 insulin pump for at least two months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
ABC-WIT Trial Summary
This trial tests a web-based tool that provides info to users of a closed-loop control system to track glycemic levels, hypo/hyperglycemia risks, and insulin pump parameters.
Who is the study for?
Adults aged 18-70 with type 1 diabetes, using insulin and an insulin pump (specifically t:slim X2) for at least six months. They must be willing to use a smartphone app, avoid pregnancy, not start new glucose-lowering drugs during the trial, and have consistent internet access.Check my eligibility
What is being tested?
The study is testing a Web-based Information Tool (WIT) that works with existing Closed-Loop Control (CLC) systems to manage diabetes by providing detailed feedback on blood sugar control and suggesting adjustments in insulin delivery.See study design
What are the potential side effects?
While the trial itself may not introduce direct side effects, participants should be aware of potential risks associated with managing their diabetes through technology such as incorrect insulin dosing or device malfunctions.
ABC-WIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I use at least 10 units of insulin daily.
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I have been using the t:slim X2 insulin pump for at least two months.
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I agree to use only specific insulins, like Humalog or Novolog, in my t:slim X2 pump and not use ultra-rapid acting insulins.
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I use or am willing to use my insulin pump's settings for meals and corrections.
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I agree not to start any new diabetes medication except insulin during the trial.
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I have been using insulin for at least 6 months.
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I am between 18 and 70 years old.
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I am not pregnant or breastfeeding.
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I have been using an insulin pump for at least 6 months.
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I have been diagnosed with type 1 diabetes for over a year.
ABC-WIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CGM-measured percent time in range 70-180 mg/dL
Secondary outcome measures
CGM-measured coefficient of variation during the day
Glucose
CGM-measured percent above 180 mg/dL during the day
+1 moreABC-WIT Trial Design
2Treatment groups
Active Control
Group I: CLC, then CLC+BAM, then CLC+ABCActive Control2 Interventions
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
Group II: CLC+ABC, then CLC+BAM, then CLCActive Control2 Interventions
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks.
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Who is running the clinical trial?
Sue BrownLead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,501 Total Patients Enrolled
Tandem Diabetes Care, Inc.Industry Sponsor
37 Previous Clinical Trials
5,590 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I use at least 10 units of insulin daily.I have been using the t:slim X2 insulin pump for at least two months.You had a very low blood sugar level that caused a seizure or made you lose consciousness in the year before joining the study.I am scheduled for surgery during the study.I agree to use only specific insulins, like Humalog or Novolog, in my t:slim X2 pump and not use ultra-rapid acting insulins.I agree not to start any new diabetes medication except insulin during the trial.I use or am willing to use my insulin pump's settings for meals and corrections.I have a bleeding disorder such as hemophilia.I am not taking any diabetes medication except for metformin or GLP-1 agonists.I have been using insulin for at least 6 months.I have not had diabetic ketoacidosis in the last year.You are currently using or planning to use the t:slim X2 insulin pump with Control-IQ technology at the time of the study's randomization (Visit 3).I am between 18 and 70 years old.I am not pregnant or breastfeeding.I have been using an insulin pump for at least 6 months.I am currently receiving treatment for seizures.I have been diagnosed with type 1 diabetes for over a year.
Research Study Groups:
This trial has the following groups:- Group 1: CLC, then CLC+BAM, then CLC+ABC
- Group 2: CLC+ABC, then CLC+BAM, then CLC
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 the age criterion for participating in this experiment restricted to those under 50?
"To qualify for this experiment, applicants must be between 18 and 70 years old. An additional 155 trials are available to those below legal age while 178 studies cater to seniors beyond the retirement age."
Answered by AI
Is it possible to enroll in this investigation?
"This clinical trial is seeking 90 volunteers between 18-70 years old who have been clinically diagnosed with type 1 diabetes mellitus for a minimum of one year and are already utilizing an insulin pump. Additionally, the participants must agree to use the t:slim X2 insulin pump with Control-IQ technology at randomization, as well as be willing to install and utilize a smart phone app during the duration of study. Furthermore, female patients enrolled in this research cannot currently be pregnant or breastfeeding when enrolling; all individuals taking part must also possess access to internet services so that they can upload data regularly if required."
Answered by AI
Does this medical experiment currently have open enrollment?
"This clinical trial is not currently enrolling participants, as stated on its listing in the clinicaltrials.gov registry; it was first posted on November 14th 2022 and last updated seven days ago. Despite this, there are 370 other trials actively seeking out volunteers at this juncture."
Answered by AI
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