T1 Diabetes Hypoglycemia Prevention Pilot

NCT02682940 | Terminated

• 1 other identifier: VG2HT1US1
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Three months

Secondary Outcomes (8)

• 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

  Three months

• 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.

  Three 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.

  Three 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.

  Three 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

  Three months

Other Outcomes (1)

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

  Three months

Study Arms (1)

Usual Care Patients on MDI or CSII

OTHER

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 Application DEVICE

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.

Usual Care Patients on MDI or CSII

Eligibility Criteria

• Age: 11 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InSpark Technologies, Inc.: lead
• Atlanta Diabetes Associates: collaborator

Study Sites (1)

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Related Publications (10)

• 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: 11023138 BACKGROUND

• 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: 2012085 BACKGROUND

• 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: 2861565 BACKGROUND

• Seaquist ER, Anderson J, Childs B, Cryer P, Dagogo-Jack S, Fish L, Heller SR, Rodriguez H, Rosenzweig J, Vigersky R. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013 May;36(5):1384-95. doi: 10.2337/dc12-2480. Epub 2013 Apr 15.

  PMID: 23589542 BACKGROUND

• 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: 22950059 BACKGROUND

• 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: 24876425 BACKGROUND

• 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: 17065680 BACKGROUND

• 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: 21216860 BACKGROUND

• Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.

  PMID: 15855602 BACKGROUND

• Cryer PE. The barrier of hypoglycemia in diabetes. Diabetes. 2008 Dec;57(12):3169-76. doi: 10.2337/db08-1084. No abstract available.

  PMID: 19033403 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laurel Fuqua, RN, MSN

  InSpark Technologies, Inc.

  STUDY CHAIR

• Bruce Bode, MD

  Atlanta Diabetes Associates

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 17, 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)