A Phase 2 interventional study of Intradermal injection and Subcutaneous injection in Type 1 Diabetes, sponsored by Massachusetts General Hospital. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-07.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment
The investigators are doing this research study to find out if the type of needle used to administer them affects the speed with which insulin and glucagon get into the blood. The investigators will compare a traditional insulin needle to an injection device, called the MicronJet, that uses microneedles to deliver medication into the top layer of your skin.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intradermal injection experiment first, followed by subcutaneous injection experiment
Procedure: Intradermal injection · Procedure: Subcutaneous injection
Subcutaneous injection experiment first, followed by intradermal injection experiment
Procedure: Intradermal injection · Procedure: Subcutaneous injection
Aggregate mean difference in tmax between the delivery methods (the insulin and glucagon data will be evaluated separately)
Time frame: 1 day
Aggregate mean difference in t1/2max between the methods
Time frame: 1 day visit
Aggregate mean difference in Cmax between the methods
Time frame: 1 day
Aggregate mean difference in area under the curve (AUC) between methods
Time frame: 1 day
AUC of 0-1 hour (and by subtraction hours 1-5)
Time frame: 1 day
AUC of 0-2 hours (and by subtraction hours 2-5)
Time frame: 1 day
Time to 50% of Total AUC (or said another way, time to 50% exposure)
Time frame: 1 day
Fraction of subjects with difference in tmax between the methods of > 25%
Time frame: 1 day
Fraction of "dry" injections with no reflux of fluid from the injection site
Time frame: 1 day
Difference in mean visual analog pain score between the two methods
Time frame: 1 day
Difference in mean visual analog pain score between insulin and glucagon with subcutaneous injection
Time frame: 1 day
Difference in mean visual analog pain score between insulin and glucagon with intradermal injection
Time frame: 1 day
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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