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T1 Diabetes Hypoglycemia Prevention Pilot

This study has been terminated.
(Insufficient Resources)
Sponsor:
Collaborator:
Atlanta Diabetes Associates
Information provided by (Responsible Party):
InSpark Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT02682940
First received: January 25, 2016
Last updated: February 28, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Diabetes Mellitus, Type 1 Hypoglycemia Device: Vigilant Diabetes Management Application

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Type I Diabetes Hypoglycemia Prevention Pilot Study

Resource links provided by NLM:


Further study details as provided by InSpark Technologies, Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 4
Actual Study Start Date: May 2016
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned 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.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   11 Years to 74 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02682940

Locations
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
Sponsors and Collaborators
InSpark Technologies, Inc.
Atlanta Diabetes Associates
Investigators
Study Chair: Laurel Fuqua, RN, MSN InSpark Technologies, Inc.
Principal Investigator: Bruce Bode, MD Atlanta Diabetes Associates
  More Information

Publications:

Responsible Party: InSpark Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02682940     History of Changes
Other Study ID Numbers: VG2HT1US1
Study First Received: January 25, 2016
Last Updated: February 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetes Mellitus
Hypoglycemia
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 21, 2017