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NCT03668808 · ClinicalTrials.gov registry record · Phase 4
Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.
A Phase 4 study of Diabetes Mellitus, Type 1, sponsored by Sansum Diabetes Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT03668808: Completed Phase 4 study of Diabetes Mellitus, Type 1, sponsored by Sansum Diabetes Research Institute.
NCT03668808 is a Phase 4 study of Diabetes Mellitus, Type 1 that has completed, run by Sansum Diabetes Research Institute. The registered enrollment target is 25 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03668808, a Phase 4 study of Diabetes Mellitus, Type 1, has completed, sponsored by Sansum Diabetes Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of the proposed study is to compare insulin Degludec \[TRESIBA® (insulin degludec injection)\] with insulin Glargine U100 \[Lantus® (insulin glargine injection)\] to determine the basal insulin of choice for adults with type 1 diabetes (T1D) who fly non-stop across multiple time zones. With the introduction of Degludec as basal insulin for T1D and the opportunity to vary time of injection between 8 and 40 hours, the use of Degludec as a basal insulin may make it easier for both people living with T1D and diabetologists to plan long-haul travel compared to the use of existing basal insulins when crossing multiple time zones.The study hypothesis is that once daily Degludec as the basal insulin will provide better glycemic control for people with type 1 diabetes on multiple daily injections who are traveling non-stop across multiple time zones than once daily Glargine U100.
Primary Outcome
Time in range (70-140 mg/dl) \[percentage of glucose readings or hours per day\] by continuous glucose monitoring (CGM) during the initial 24 hours local time (starting within 2 hours after arriving) in Newark, NJ after flying 9-10 hours West to East (from Honolulu, HI) and after the return journey from Newark to Honolulu (flying East to West).
Conditions Studied
Interventions
- DRUG Insulin Glargine
- DRUG Insulin Degludec
- DEVICE TRESIBA® FLEXTOUCH®
- DEVICE LANTUS® SOLOSTAR® INSULIN PEN
Study Locations (2)
California
- Sansum Diabetes Research Institute - Santa Barbara
Hawaii
- inControl Diabetes Center - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-11-16 |
| Est. Completion | 2020-09-19 |
| Phase | Phase 4 |
What the finished NCT03668808 record still lists
NCT03668808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 4 interventions - of which Insulin Glargine is the first listed.
NCT03668808 reports a single indexed study location in California, Hawaii.
Frequently Asked Questions
What is clinical trial NCT03668808 about?
NCT03668808 is a clinical study titled "Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.". The purpose of the proposed study is to compare insulin Degludec \[TRESIBA® (insulin degludec injection)\] with insulin Glargine U100 \[Lantus® (insulin glargine injection)\] to determine the basal insulin of choice for adults with type 1 diabetes (T1D) who fly non-stop across multiple time zones. W...
What is the current status of trial NCT03668808?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2018-11-16. Estimated completion is 2020-09-19.
What conditions does trial NCT03668808 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT03668808?
The interventions under investigation include: Insulin Glargine (DRUG), Insulin Degludec (DRUG), TRESIBA® FLEXTOUCH® (DEVICE), LANTUS® SOLOSTAR® INSULIN PEN (DEVICE).
Who is sponsoring clinical trial NCT03668808?
This trial is sponsored by Sansum Diabetes Research Institute, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03668808 being conducted?
This trial has 2 study locations across California, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
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 NCT03668808's enrollment target sits among peer trials
25 93rd of 118 higher than 26 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 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.
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