NCT02906891 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cryer PE, Gerich JE
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Edelman SV, Blose JS
The Impact of Nocturnal Hypoglycemia on Clinical and Cost-Related Issues in Patients With Type 1 and Type 2 Diabetes. Diabetes Educ. 2014 May;40(3):269-279.
Epidemiology of severe hypoglycemia in the diabetes control and complications trial
The DCCT Research Group. Am J Med. 1991 Apr;90(4):450-9.
Ha WC, Oh SJ, Kim JH, Lee JM, Chang SA, Sohn TS, Son HS
Severe hypoglycemia is a serious complication and becoming an economic burden in diabetes. Diabetes Metab J. 2012 Aug;36(4):280-4. doi: 10.4093/dmj.2012.36.4.280.
Kovatchev BP, Mendosa P, Anderson S, Hawley JS, Ritterband LM, Gonder-Frederick L
Effect of automated bio-behavioral feedback on the control of type 1 diabetes. Diabetes Care. 2011 Feb;34(2):302-7. doi: 10.2337/dc10-1366.
Kovatchev BP, Otto E, Cox D, Gonder-Frederick L, Clarke W
Evaluation of a new measure of blood glucose variability in diabetes. Diabetes Care. 2006 Nov;29(11):2433-8.
Otto EA, Tannan V
Evaluation of the utility of a glycemic pattern identification system. J Diabetes Sci Technol. 2014 Jul;8(4):830-8. doi: 10.1177/1932296814532210.
ter Braak EW, Appelman AM, van de Laak M, Stolk RP, van Haeften TW, Erkelens DW
Clinical characteristics of type 1 diabetic patients with and without severe hypoglycemia. Diabetes Care. 2000 Oct;23(10):1467-71.

A Pilot Study of Nocturnal Hypoglycemia Prevention in Type 1 Diabetes Using the Vigilant Diabetes Management Companion

Clinical trial NCT02906891 - References