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NCT01945099 · ClinicalTrials.gov registry record · Early Phase 1
Acceleration of Insulin Action by Hyaluronidase During Closed-Loop Therapy
A Early Phase 1 study of Type 1 Diabetes, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT01945099: Completed Early Phase 1 study of Type 1 Diabetes, sponsored by Yale University.
NCT01945099 is a Early Phase 1 study of Type 1 Diabetes that has completed, run by Yale University. The registered enrollment target is 13 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01945099, a Early Phase 1 study of Type 1 Diabetes, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
"Closed loop artificial pancreas" systems have been under development for the control of blood sugars in those living with diabetes. These systems consist of a continuous glucose sensor, which sends a signal to a computer program that automatically determines how much insulin to give. The computer program then tells an insulin pump to deliver the insulin. While such systems have been tested under a number of conditions, post-meal blood sugars are difficult to control. Specifically, we will be looking to see if using hyaluronidase improves the ability of the closed loop artificial pancreas to better respond to meal related highs and lows.
Primary Outcome
Peak post-prandial plasma glucose excursions (mg/dL) after breakfast, lunch, and dinner on days #2, #3 and #4. One day with hylauronidase pre-treated insulin infusion site site, other day with hyaluronidase-rapid acting insulin co-formulation infusion and control day with rapid acting insulin only.
Conditions Studied
Interventions
- DEVICE ePID closed loop system
- DRUG hyaluronidase
- DRUG Lispro-PH20
Study Locations (1)
Connecticut
- Yale University School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-07 |
| Phase | Early Phase 1 |
What the finished NCT01945099 record still lists
NCT01945099 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which ePID closed loop system is the first listed.
NCT01945099 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT01945099 about?
NCT01945099 is a clinical study titled "Acceleration of Insulin Action by Hyaluronidase During Closed-Loop Therapy". "Closed loop artificial pancreas" systems have been under development for the control of blood sugars in those living with diabetes. These systems consist of a continuous glucose sensor, which sends a signal to a computer program that automatically determines how much insulin to give. The computer p...
What is the current status of trial NCT01945099?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 13 participants. The study started on 2013-09. Estimated completion is 2016-07.
What conditions does trial NCT01945099 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT01945099?
The interventions under investigation include: ePID closed loop system (DEVICE), hyaluronidase (DRUG), Lispro-PH20 (DRUG).
Who is sponsoring clinical trial NCT01945099?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01945099 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01945099's enrollment target sits among peer trials
13 173rd of 198 higher than 24 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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