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Artificial Pancreas System
CL/AP system for Type 1 Diabetes (T1DM AP Trial)
N/A
Waitlist Available
Led By Raimund Herzog, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 8-10 weeks
Awards & highlights
T1DM AP Trial Summary
This trial shows that a new insulin pump system can help prevent low blood sugar episodes and improve brain function in elderly people with Type 1 diabetes.
Eligible Conditions
- Type 1 Diabetes
T1DM AP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 8-10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8-10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain
Secondary outcome measures
Change in Cognitive Function: Grooved Pegboard Test
Change in Cognitive Function: MOCA
Change in Cognitive Function: Trail Test A
+1 moreT1DM AP Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: CL/AP systemActive Control1 Intervention
To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients.
Group II: usual carePlacebo Group1 Intervention
Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,488 Total Patients Enrolled
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,206 Total Patients Enrolled
Raimund Herzog, MDPrincipal InvestigatorYale School of Medicine Department of Endocrinology
5 Previous Clinical Trials
171 Total Patients Enrolled
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