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Expert System
CGM + SAM Therapy for Type 1 Diabetes (DSS-2 Trial)
N/A
Recruiting
Led By Marc Breton, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of type 1 diabetes for at least one year and using insulin for at least one year
Age 18 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months
Awards & highlights
DSS-2 Trial Summary
This trial will compare a Continuous Glucose Monitor (CGM) with Sensor Augmented Mode (SAM) therapy to see which is more effective in Type 1 Diabetes Mellitus (T1DM). It will also study how different psychological factors affect the performance of these systems, in order to optimize glycemic control and reduce the psychological impact of the system.
Who is the study for?
Adults with Type 1 Diabetes who've been on insulin for at least a year, have stable mental status and cognition, are not pregnant or planning to become pregnant during the study. They must have internet access for device uploads and video calls, an HbA1c level between 6.0-11.0%, and be willing to use contraception if applicable.Check my eligibility
What is being tested?
The trial is testing a Continuous Glucose Monitor (CGM)-based advisory system against Sensor Augmented Mode therapy in managing Type 1 Diabetes Mellitus. It also assesses how personal behaviors affect the system's advice delivery and aims to personalize it for better glucose control.See study design
What are the potential side effects?
While specific side effects are not listed, potential issues may include discomfort from wearing devices, skin irritation from sensors or adhesives, psychological impact of continuous monitoring, and possible errors in glucose readings leading to mismanagement.
DSS-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with type 1 diabetes and using insulin for over a year.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with type 1 diabetes and have been using insulin for at least a year.
DSS-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glycemic Outcomes
Secondary outcome measures
High Blood Glucose Index
Low Blood Glucose Index
average glycemia
+5 moreDSS-2 Trial Design
2Treatment groups
Experimental Treatment
Group I: EscalationExperimental Treatment3 Interventions
Subjects randomized to this arm will proceed from SAM to PF to DSS
Group II: De-escalationExperimental Treatment3 Interventions
Subjects randomized to this arm will proceed from DSS to PF to SAM
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decision Support System
2015
N/A
~40
Personalized Feedback
2013
N/A
~900
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,244,973 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,492 Total Patients Enrolled
Marc Breton, PhDPrincipal Investigator - University of Virginia Center for Diabetes Technology
University of Virginia
7 Previous Clinical Trials
181 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with type 1 diabetes and using insulin for over a year.I am mentally capable of participating in the study.I have a bleeding disorder such as hemophilia.Your HbA1c level is between 6.0% and 11.0%.I have been on a stable non-insulin diabetes treatment for the last 3 months and am willing to keep it unchanged for the study.I am currently being treated for seizures.I can use all study devices correctly and follow the study rules.I have heart issues but got clearance from a cardiologist.I am not on medications that could affect the trial's results.I am 18 years old or older.I use NPH insulin for my diabetes.I have been diagnosed with type 1 diabetes and have been using insulin for at least a year.
Research Study Groups:
This trial has the following groups:- Group 1: De-escalation
- Group 2: Escalation
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.
How many respondents are engaging in this research endeavor?
"Affirmative. The clinicaltrials.gov website states that this trial is presently recruiting participants, with 100 test subjects being sought from a single medical centre since the initial posting on September 4th 2020 and recent edit on January 13th 2022."
Answered by AI
Is enrollment currently available for those wishing to participate in this trial?
"As per the information on clinicaltrials.gov, this trial is currently searching for participants. It was first announced in September 2020 and revised as recent as January 2022."
Answered by AI
Who else is applying?
What state do they live in?
Alabama
North Carolina
Virginia
How old are they?
18 - 65
What site did they apply to?
University of Virginia Center for Diabetes Technology
What portion of applicants met pre-screening criteria?
Met criteria
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