Type I Diabetes Hypoglycemia Prevention Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- InSpark Technologies, Inc.
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Aggregate reduction in the rate of mild hypoglycemia (biochemical and logged) as measured by meter or logged home blood glucose values <56 mg/dL at 3 months, compared to the monthly rate of hypoglycemia in the baseline period.
Study Overview
Brief Summary
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.
Detailed 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:
- Blood Glucose Reading review and editing: The user will be able to review data logs and manually edit blood glucose results.
- Pattern Messages: Alerts the user that one or more patterns were found in the results that were entered, including patterns that are indicative of risk of severe hypoglycemia in the next 24 hours.
- Long Term Control Summary: Identifies the current and retrospective blood glucose averages and variability.
The following blood glucose patterns will be identified by the Vigilant application:
- Weekly and monthly glucose averages overall and within daily time periods
- Daily periods of infrequent testing
- Daily periods of high, low or variable blood glucose ("Daily Pattern Messaging System")
- Patterns of blood glucose indicative of increased risk of low blood glucose levels in the next 24 hours ("Hypo Risk Indicator")
- Weekly and monthly blood glucose variability ("Average Daily Risk Range or ADDR")
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 11 Years to 74 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male & female ages 11-74
- •At least 10% of readings are hypoglycemia (<70mg/dL) in meter download
- •Clinical diagnosis of T1 DM
- •MDI (Multiple Daily Insulin Injections) or CSII (Continuous Subcutaneous Insulin Infusion) for at least six months
- •Willing to monitor and records signs & symptoms of hypo
- •SMBG (Self Monitoring Blood Glucose) at least three per day for last 30 days
- •Ability to use Android or IOS mobile phone
- •No CGM (Continuous Glucose Monitoring) Users
Exclusion Criteria
- •Pregnancy
- •Unable to use the technology (no Android / iOS device)
- •Any condition that in the investigators judgment is likely to cause the participant to be unable to understand or provide informed consent
- •Unwilling to use SMBG at least three times a day
- •Unwilling to monitor and record signs and symptoms of hypoglycemia
- •Individuals who are unwilling to share their glucose meter
- •Active CGM or anticipated use of CGM if in the study
- •Severe visual impairment
Arms & Interventions
Usual Care Patients on MDI or CSII
Usual care patients on multiple daily injections of insulin (MDI) or insulin pumps (CSII) will be their own controls against baseline and will use the Vigilant Diabetes Management Application in conjunction with a wireless blood glucose meter for three months.
Intervention: Vigilant Diabetes Management Application (Device)
Outcomes
Primary Outcomes
Aggregate reduction in the rate of mild hypoglycemia (biochemical and logged) as measured by meter or logged home blood glucose values <56 mg/dL at 3 months, compared to the monthly rate of hypoglycemia in the baseline period.
Time Frame: Three months
Reduction in the rate of biochemical mild (meter downloaded BG\<56mg/dL) \& logged (other hypoglycemia not recorded in meter but noted in log books) hypoglycemia below 56mg/dl in the 3 month intervention period versus the baseline period. Logged values will be considered in the calculation if no duplicate hypoglycemic readings within 15 minutes of the logged value can be found in the patient's blood glucose meter download data.
Secondary Outcomes
- An aggregate reduction in the mean glycemic variability, as measured by monthly ADRR (Average Daily Risk Range), calculated based on downloaded meter download data(Three months)
- An aggregate reduction in average HbA1will be measured at baseline using DCA 2000 or equivalent NGSP-certified point-of-care method or local laboratory at 3 months, compared to HbA1c levels obtained at study initiation.(Three months)
- Improvement in self-reported lost work productivity as a result of hypoglycemia. Individuals will complete a questionnaire about lost work days as a result of hypoglycemia at baseline and at 3 months.(Three months)
- An aggregate (total study population) reduction in the LBGI and HBGI, as measured by percent of readings in and out of range calculated based on downloaded blood glucose meter download data.(Three months)
- An aggregate reduction in the survey self-reported rate of use of; 1) Glucagon 2) Emergency medical services for hypoglycemia, and 3) Hospital, urgent care or clinic visits for hypoglycemia or associated with hypoglycemia care visits.(Three months)
- Reduction in reported fear of hypoglycemia as compared to baseline Fear of Hypoglycemia Fear Survey. The Hypoglycemia Fear Survey II (HSF II) will be used.(Three months)
- Improvement in self-reported psychosocial self-efficacy as compared to baseline measured using the Diabetes Empowerment Scale Short Form (DES-SF).(Three months)
- An aggregate reduction in the rate of biochemical severe hypoglycemia as measured by meter or logged home blood glucose values <40 mg/dL, at 3 months, compared to the monthly rate in the baseline period(Three months)