NCT02906891

Brief Summary

A single center pilot study assessing the Vigilant Diabetes Management Companion for the prevention of recurrent nocturnal hypoglycemia in type I diabetes patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

February 19, 2016

Last Update Submit

February 28, 2017

Conditions

HypoglycemiaDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    3 months

  • 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).

    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.

    3 months

Secondary Outcomes (9)

  • 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.

    3 months

  • 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.

    3 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.

    3 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.

    3 months

  • An aggregate reduction in the mean glycemic variability, as measured by monthly ADRR (Average Daily Risk Range), calculated based on downloaded meter download data

    3 months

  • +4 more secondary outcomes

Other Outcomes (1)

  • Average ratings of "acceptable" or better from self-reported survey clinician feedback on the utility of Vigilant in managing patients.

    3 months

Study Arms (1)

Usual Care Patients on MDI or CSII

EXPERIMENTAL

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

Interventions

Vigilant Diabetes Management ApplicationDEVICE

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.

Also known as: Vigilant
Usual Care Patients on MDI or CSII

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Related Publications (8)

  • ter Braak EW, Appelman AM, van de Laak M, Stolk RP, van Haeften TW, Erkelens DW. Clinical characteristics of type 1 diabetic patients with and without severe hypoglycemia. Diabetes Care. 2000 Oct;23(10):1467-71. doi: 10.2337/diacare.23.10.1467.

    PMID: 11023138RESULT

  • Epidemiology of severe hypoglycemia in the diabetes control and complications trial. The DCCT Research Group. Am J Med. 1991 Apr;90(4):450-9.

    PMID: 2012085RESULT

  • Cryer PE, Gerich JE. Glucose counterregulation, hypoglycemia, and intensive insulin therapy in diabetes mellitus. N Engl J Med. 1985 Jul 25;313(4):232-41. doi: 10.1056/NEJM198507253130405.

    PMID: 2861565RESULT

  • Ha WC, Oh SJ, Kim JH, Lee JM, Chang SA, Sohn TS, Son HS. Severe hypoglycemia is a serious complication and becoming an economic burden in diabetes. Diabetes Metab J. 2012 Aug;36(4):280-4. doi: 10.4093/dmj.2012.36.4.280. Epub 2012 Aug 20.

    PMID: 22950059RESULT

  • Otto EA, Tannan V. Evaluation of the utility of a glycemic pattern identification system. J Diabetes Sci Technol. 2014 Jul;8(4):830-8. doi: 10.1177/1932296814532210. Epub 2014 May 12.

    PMID: 24876425RESULT

  • Kovatchev BP, Otto E, Cox D, Gonder-Frederick L, Clarke W. Evaluation of a new measure of blood glucose variability in diabetes. Diabetes Care. 2006 Nov;29(11):2433-8. doi: 10.2337/dc06-1085.

    PMID: 17065680RESULT

  • Kovatchev BP, Mendosa P, Anderson S, Hawley JS, Ritterband LM, Gonder-Frederick L. Effect of automated bio-behavioral feedback on the control of type 1 diabetes. Diabetes Care. 2011 Feb;34(2):302-7. doi: 10.2337/dc10-1366. Epub 2011 Jan 7.

    PMID: 21216860RESULT

  • Edelman SV, Blose JS. The Impact of Nocturnal Hypoglycemia on Clinical and Cost-Related Issues in Patients With Type 1 and Type 2 Diabetes. Diabetes Educ. 2014 May;40(3):269-279. doi: 10.1177/0145721714529608. Epub 2014 Apr 2.

    PMID: 24695260RESULT

MeSH Terms

Conditions

HypoglycemiaDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Laurel Fuqua, RN, MSN

    InSpark Technologies, Inc.

    STUDY CHAIR

  • Robert Tanenberg, MD

    East Carolina University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2016

First Posted

September 20, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 3, 2017

Record last verified: 2017-02

Locations

US(1)