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A Pilot Study of Nocturnal Hypoglycemia Prevention in Type 1 Diabetes Using the Vigilant Diabetes Management Companion

This study has been terminated.
(Insufficient resources to complete study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02906891
First Posted: September 20, 2016
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
East Carolina University
Information provided by (Responsible Party):
InSpark Technologies, Inc.
  Purpose
A single center pilot study assessing the Vigilant Diabetes Management Companion for the prevention of recurrent nocturnal hypoglycemia in type I diabetes patients.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study of Nocturnal Hypoglycemia Prevention in Type 1 Diabetes Using the Vigilant Diabetes Management Companion

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


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: 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.


Enrollment: 13
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
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • Male or female participants aged between 18 and 75 years

    • Clinical diagnosis of type 1 diabetes mellitus and using multiple daily injections or CSII for at least six months
    • Patient has had documented nocturnal hypoglycemia in the last 2 months with an associated blood sugar reading less than 56mg/dL. Night is defined as the 8 hour interval when the patient usually sleeps (I.e. 11:00 pm to 7:00 am, for example).

OR

  • Patient has had at least 1 severe low at night in the last 6 months (helped by another). Night is defined as the 8 hour interval when the patient usually sleeps (I.e. 11:00 pm to 7:00 am, for example).
  • Willing to monitor and record signs and symptoms of hypoglycemia
  • Willing to test blood glucose levels at least three times a day
  • Ability to use Android or IOS mobile phone
  • No CGM Users

Exclusion Criteria:

  • • Pregnancy

    • Unable to use the technology
    • Any condition that in the investigators judgment is likely to cause the participant to be unable e 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 data
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
InSpark Technologies, Inc.
East Carolina University
Investigators
Study Chair: Laurel Fuqua, RN, MSN InSpark Technologies, Inc.
Principal Investigator: Robert Tanenberg, MD East Carolina University
  More Information

Publications:

Responsible Party: InSpark Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02906891     History of Changes
Other Study ID Numbers: VG2NOCHPUS1
First Submitted: February 19, 2016
First Posted: September 20, 2016
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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