Sensor-Augmented Pump therapy for Type 1 Diabetes

University of Virginia Center for Diabetes Technology, Charlottesville, VA
Type 1 DiabetesSensor-Augmented Pump therapy - Device
Eligibility
18+
All Sexes

Study 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.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 7 months

7 Months
Glycemic Outcomes
7 months
High Blood Glucose Index
Low Blood Glucose Index
average glycemia
average gycemia
percent time above 250 mg/dL
percent time above range
percent time below recommended threshold
percent time in clinical hypoglycemia
percent time in target range

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Escalation
1 of 2
De-escalation
1 of 2

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Sensor-Augmented Pump therapy · No Placebo Group · N/A

EscalationExperimental Group · 4 Interventions: Sensor-Augmented Pump therapy, Personalized Feedback, Decision Support System, Sensor Augmented Mode · Intervention Types: Device, Device, Device, Device
De-escalationExperimental Group · 4 Interventions: Sensor-Augmented Pump therapy, Personalized Feedback, Decision Support System, Sensor Augmented Mode · Intervention Types: Device, Device, Device, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Personalized Feedback
2013
N/A
~900
Decision Support System
2015
N/A
~40

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 7 months

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,213 Previous Clinical Trials
4,193,609 Total Patients Enrolled
University of VirginiaLead Sponsor
707 Previous Clinical Trials
1,468,169 Total Patients Enrolled
Marc Breton, PhDPrincipal Investigator - University of Virginia Center for Diabetes Technology
University of Virginia
7 Previous Clinical Trials
177 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The investigator thinks that taking other medications might not be safe for you during the trial.
You cannot participate if you are already in another drug or device trial either during this study or at the time of enrollment.
You are taking steroid medication by mouth.

Who else is applying?

What state do they live in?
Alabama33.3%
North Carolina33.3%
Virginia33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Virginia Center for Diabetes Technology100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.