T1 Diabetes Hypoglycemia Prevention Pilot
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|ClinicalTrials.gov Identifier: NCT02682940|
Recruitment Status : Terminated (Insufficient Resources)
First Posted : February 17, 2016
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1 Hypoglycemia||Device: Vigilant Diabetes Management Application||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Type I Diabetes Hypoglycemia Prevention Pilot Study|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
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
Subjects will download the Vigilant Diabetes Management 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.
- 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.
- 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 [ Time Frame: Three months ]Time adjusted reduction in rates of reported severe hypoglycemia in the six months prior to the study versus the intervention period. 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 blood glucose meter download data.
- 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: Three 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.
- 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: Three months ]Reduction in HbA1c in three months vs baseline period. (biochemical and logged)
- 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: Three 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. 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: Three 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.
- 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: Three 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: Three 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: Three 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: Three 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): NCT02682940
|United States, Georgia|
|Atlanta Diabetes Associates|
|Atlanta, Georgia, United States, 30318|
|Study Chair:||Laurel Fuqua, RN, MSN||InSpark Technologies, Inc.|
|Principal Investigator:||Bruce Bode, MD||Atlanta Diabetes Associates|