A Pilot Study of Nocturnal Hypoglycemia Prevention in Type 1 Diabetes Using the Vigilant Diabetes Management Companion
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|ClinicalTrials.gov Identifier: NCT02906891|
Recruitment Status : Terminated (Insufficient resources to complete study)
First Posted : September 20, 2016
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment|
|Hypoglycemia Diabetes Mellitus, Type 1||Device: Vigilant Diabetes Management Application|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Nocturnal Hypoglycemia Prevention in Type 1 Diabetes Using the Vigilant Diabetes Management Companion|
|Study Start Date :||May 2016|
|Primary Completion Date :||December 2016|
|Study Completion Date :||December 2016|
Experimental: Usual Care Patients on MDI or CSII
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.
Device: Vigilant Diabetes Management Application
The Vigilant Diabetes Management Companion by InSpark Technologies was developed to assist in the prevention of hypoglycemia by providing the individual with an unobtrusive analysis of their blood glucose values and notifying them about periods of upcoming risk for low and high blood glucose; and in particular periods of risk for severe hypoglycemia. This allows the individual to take preventive corrective action. Subjects will download the Vigilant DiabetesManagement Application and use it in conjunction with a study supplied wireless blood glucose meter. They will check blood glucose values at least three times a day and receive summaries and notifications from Vigilant regarding periods of risk and blood glucose patterns.
Other Name: Vigilant
- Reduction in the aggregate rate of nocturnal biochemical severe hypoglycemia in the Vigilant period versus the Baseline period as measured by meter or logged blood glucose values (mg/dL). [ Time Frame: 3 months ]Nocturnal biochemical severe hypoglycemia is defined by 1) a reading below 56 mg/dL at night OR 2) a severe low (requires assistance from another) at night. Night is defined as the 8 hour interval when the patient usually sleeps (ie. 11:00pm to 7:00 am, for example). Baseline is defined as collected glycemic data prior to Vigilant initiation as well as the run-in period.
- Reduction in the aggregate rate of nocturnal hypoglycemia in the Vigilant period versus the Baseline period as measured by meter or logged blood glucose values (mg/dL). [ Time Frame: 3 months ]
Nocturnal hypoglycemia is defined by 1) a reading below 70 mg/dL at night OR 2) a severe low (requires assistance from another) at night.Night is defined as the 8 hour interval when the patient usually sleeps (I.e. 11:00 pm to 7:00 am, for example).
Night is defined as the 8 hour interval when the patient usually sleeps (ie. 11:00pm to 7:00 am, for example. Baseline is defined as collected glycemic data prior to Vigilant initiation as well as the run-in period.
- An aggregate (total study population) reduction in the rate of mild hypoglycemia (biochemical and logged) as measured by home blood glucose values <70 mg/dL at 3 months, compared to the monthly rate of hypoglycemia in the Baseline period. [ Time Frame: 3 months ]Logged values will only be considered in the calculation if no duplicate hypoglycemic readings within 15 minutes of the logged value can be found in the patient's meter download data.
- An aggregate reduction in the rate of biochemical severe hypoglycemia as measured by home blood glucose values <40 mg/dL, during months 1-3, compared to the monthly rate of biochemical severe hypoglycemia in the Baseline period. [ Time Frame: 3 months ]biochemical and logged) Logged values will only be considered in the calculation if no duplicate hypoglycemic readings within15 minutes of the logged value can be found in the patient's meter download data.
- 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. [ Time Frame: 3 months ]Reduction in HbA1c in three months vs baseline period.
- 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. [ Time Frame: 3 months ]Reduction in Glucagon use, Emergency services use, Hospitalizations and or ER/Urgent Care visits for hypoglycemia events vs baseline. In the intervention period, compared to the rate in the 3 month period prior to study initiation. Total study population data will be obtained from adding up the number of incidents on the self-reported surveys. In the event that additional data on emergency medical services, hospital, urgent care or clinical visits is available through the clinician of the patient, or through the patient's health plan or insurance, and the patient elects to provide this information for the benefit of the study, these records will be used to verify and / or supplement occurrences. Any record discrepancy will be resolved at the discretion of the principal investigator
- An aggregate reduction in the mean glycemic variability, as measured by monthly ADRR (Average Daily Risk Range), calculated based on downloaded meter download data [ Time Frame: 3 months ]Reduction in glycemic variability using the ADRR measure vs baseline period at 3 months, compared mean monthly ADRR value based on meter downloads at the end of the baseline period.
- 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. [ Time Frame: 3 months ]Reduction in LBGI and HBGI in the three month intervention period versus baseline. In range = 70-180 mg/dL, Out of range is < 70 and > 180 mg/dL). At 3 months, compared to mean monthly percent of readings in and out of range based on blood glucose meter downloads at the end of the baseline period.
- 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. [ Time Frame: 3 months ]
Reduction in reported fear of hypoglycemia and improvement in quality of life as compared to baseline survey results. It is a validated scale that consists of questions that measure behaviors involved in avoidance and over treatment of hypoglycemia and a worry subscale that measures anxiety and fear surrounding hypoglycemia. The Hypoglycemic Fear Survey endpoint will be met if the average ratings across all survey questions will be improved at 3 months, versus at study initiation.
Exploratory analyses of the association of Hypoglycemia Fear Survey answers and clinical improvement will be done at the discretion of the Principal Investigator and Sponsor
- 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. [ Time Frame: 3 months ]Improvement in lost work productivity as a result of hypoglycemia as compared to self reported baseline survey results.
- Improvement in self-reported psychosocial self-efficacy as compared to baseline measured using the Diabetes Empowerment Scale Short Form (DES-SF). [ Time Frame: 3 months ]Improvement in self reported diabetes psychosocial self-efficacy. The Diabetes is an abbreviated, validated scale of the Diabetes Empowerment Scale (DES), which was developed and validated by the Michigan Diabetes Research Center for the measurement of psychosocial self-efficacy of people with diabetes.
- Average ratings of "acceptable" or better from self-reported survey clinician feedback on the utility of Vigilant in managing patients. [ Time Frame: 3 months ]The secondary endpoint for clinicians will be met with average ratings of "acceptable" or better from self- reported clinician feedback on a survey on the utility of Vigilant in managing patients in their practice; supporting medication titration, facilitating positive treatment decisions, providing meaningful feedback and reducing time spent doing data analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906891
|United States, North Carolina|
|East Carolina University|
|Greenville, North Carolina, United States, 27834|
|Study Chair:||Laurel Fuqua, RN, MSN||InSpark Technologies, Inc.|
|Principal Investigator:||Robert Tanenberg, MD||East Carolina University|