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A single center pilot study assessing the Vigilant Diabetes Management System for the prevention of recurrent mild to moderate hypoglycemia in type I diabetes patients.
Full description
This is a single center 12-week Pilot trial with one arm. Subjects will serve as their own controls. The study will include usual care patients on MDI (multiple daily injections) or CSII (continuous subcutaneous insulin infusion) with the additional use of the Vigilant ™ Diabetes Management System. There will be a 4-week baseline period prior to the 12-week intervention. Subject participation for the 4-week baseline period will last for 2-4 hours during two visits. Subjects participating in the intervention phase of 12 weeks will require one additional visit (2-3 hours) at 3 months, which is routine for this population. Participants will be provided with a wireless blood glucose meter for the duration of the study and will download the Vigilant mobile application to their mobile phone.
The Vigilant™ system stores blood glucose test results, pattern events, and user settings. In addition to receiving blood glucose measurements entered from the user, storing and displaying them, Vigilant™ provides the following features and tools for the user:
The following blood glucose patterns will be identified by the Vigilant application:
Vigilant™ incorporates a "Tutorial Mode" which offers detailed feedback on the meaning of pattern analyses performed by the software. In addition, two separate training videos have been developed for patients and clinicians to initiate them on use and understanding of the device and its features.
Caregivers will have access to the information outlined above, as well as summary screens that highlight glycemic control metrics and patients and risk notifications for all of their patients on Vigilant, subject to patient approval.
Subjects will be recruited from one diabetes clinic. Patients with type I diabetes and a history of mild to moderate hypoglycemia will be assessed to see if they are eligible for the study. All those who are considered eligible will be approached to give their written, informed consent before attending a screening visit where the inclusion criteria will be checked.
At the Screening Visit the following procedures will be performed / criteria will be checked and documented:
After consent, participants will participate in the 4-week run in/baseline period before the 12 week pilot intervention to collect baseline data on glycemic control and hypoglycemia and to assess adherence with testing criteria. All participants will be asked to conduct SMBG(self-monitoring of blood glucose) three or more times a day and asked to record the clinical details of any hypoglycemia events.
At the end of the 4-week baseline period, participants will return for a study visit where the investigator will complete the following:
To continue in the study, subjects will need to have obtained at least three blood glucose values per day and have recorded hypoglycemia symptoms and episodes.
Prior to the 12-week intervention period, all study participants will complete validated study questionnaires (Hypoglycemia Fear, Diabetes Empowerment Survey etc.).
At visit 2, the subjects will complete training with the Vigilant™ program. They will watch a video demonstration on an iPhone , Android or iPod Touch that explains the use of the Vigilant™ device. Study participants will be provided a wireless blood glucose monitor and asked to follow their normal diabetes management program for the subsequent 12 weeks. They will be asked to use the Vigilant™ program at home in conjunction with the provided wireless meter for the subsequent 12 weeks, according to the following instructions:
The subject will follow their typical blood glucose-testing regimen, with the exception that they must perform an average of at least 3 fingerstick blood glucose measurements daily during that time.
Participants will be followed up at three months during the 12-week intervention period. Subjects will also receive a telephone or email communication from the study manager within several days of the beginning of the home use portion of the study to ensure the patient understands the protocol and is entering data according to instructions. At this time they will also be asked to send several screen shots of their application with a log of their data and patterns that have been identified, to ensure the device is working according to the intended use and data is being entered. Another follow up will occur 4 weeks into the study where the patients will be asked the same questions and given the same instructions.
Subjects involved in this study should also allow their Vigilant-using clinician to see their Vigilant patterns, and also plan to see their Vigilant-using clinician at least once for a regular check up during their Vigilant use period (this can be done at Visit 3, if desired).
A follow-up and final visit (3) will occur at the three-month end of the 12 week intervention period, which is the typical routine schedule for usual care. Additional visits may be scheduled by provider as indicated for diabetes management. The following procedures will be performed in at the follow-up visit:
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Data sourced from clinicaltrials.gov
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