Comparing Internet Blood Glucose Monitoring System and Continuous Glucose Monitoring System

NCT01162694 | Suspended

• 1 other identifier: IBGMS vs CGMS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Management of type 2 diabetes is an ongoing challenge for patients and their doctors. In order to prevent short and long term complications, patients need to monitor and control their blood sugar levels. In addition, they may need to have an ongoing communication with their doctor in order to modify treatment. In this study the investigators wish to compare two systems of monitoring and communication of blood sugar levels. The first is the use of continuous glucose monitoring system and the second is the use of an Internet-based glucose monitoring system. The investigators want to compare their effect and/or benefits.

Conditions

Type 2 Diabetes Mellitus

Keywords

Remote Blood Glucose Monitoring System,; Continuous Glucose Monitoring System,; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the A1c level or the change in A1c level

  6 Months

Secondary Outcomes (2)

• The secondary endpoint include severe hypoglycemia defined as requiring external aid (hospital or other).

  6 Months

• A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours

  6 monthns

Study Arms (2)

Internet Intervention

ACTIVE COMPARATOR

The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and comment upon.

Other: Remote Blood Glucose Monitoring

Continuous Glucose Monitoring

ACTIVE COMPARATOR

The use of CGMS (Sensor, receiver, transmitter) plus the uploading of results to the Internet-based software utility of CareLink Personal and generating reports that can be viewed and used at the patient's own preference. This group will send the uploaded data and receive feedback from their endocrinologist every 2 weeks.

Other: Continuous Glucose Monitoring

Interventions

Remote Blood Glucose Monitoring OTHER

The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and comment upon.

Also known as: Internet Blood Glucose Monitoring System

Internet Intervention

Continuous Glucose Monitoring OTHER

The use of CGMS (Sensor, receiver, transmitter) (Medtronic Diabetes) plus the uploading of results to the Internet-based software utility of CareLink Personal and generating reports that can be viewed and used at the patient's own preference. This group will not receive feedback or suggestion based on the uploaded glucose data.

Also known as: Sensors, CGMS

Continuous Glucose Monitoring

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes patients being treated with insulin for at least 3 months
• HbA1c \> 7%
• \> 25 years of age
• Willingness to test blood glucose levels a minimum of 3 times daily
• Willingness to be trained on using the Continuous Glucose Monitoring System
• Willingness to be randomized
• Trained in self-blood glucose monitoring
• Internet Access on a Windows Personal Computer
• No prior use or training on CGMS in the past 6 months
• No prior use or training on IBGMS in the past 6 months

You may not qualify if:

• Patient with medical conditions that may affect their study participation or results will be excluded.
• Patients with the potential to become pregnant
• Patients using medications known to influence control of diabetes (eg steroids systemic or inhaled)
• Liver disease (AST or ALT levels \> 2.5 times the reference level)
• Renal insufficient with a serum creatinine level \> 200 μmol/L

Sponsors & Collaborators

• Endocrine Research Society: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Related Publications (6)

• Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.

  PMID: 16371630 BACKGROUND

• Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.

  PMID: 9742976 BACKGROUND

• Hirsch IB, Bode BW, Childs BP, Close KL, Fisher WA, Gavin JR, Ginsberg BH, Raine CH, Verderese CA. Self-Monitoring of Blood Glucose (SMBG) in insulin- and non-insulin-using adults with diabetes: consensus recommendations for improving SMBG accuracy, utilization, and research. Diabetes Technol Ther. 2008 Dec;10(6):419-39. doi: 10.1089/dia.2008.0104.

  PMID: 18937550 BACKGROUND

• Klonoff DC, Bergenstal R, Blonde L, Boren SA, Church TS, Gaffaney J, Jovanovic L, Kendall DM, Kollman C, Kovatchev BP, Leippert C, Owens DR, Polonsky WH, Reach G, Renard E, Riddell MC, Rubin RR, Schnell O, Siminiero LM, Vigersky RA, Wilson DM, Wollitzer AO. Consensus report of the coalition for clinical research-self-monitoring of blood glucose. J Diabetes Sci Technol. 2008 Nov;2(6):1030-53. doi: 10.1177/193229680800200612.

  PMID: 19885292 BACKGROUND

• Austin MM, Haas L, Johnson T, Parkin CG, Parkin CL, Spollett G, Volpone MT. Self-monitoring of blood glucose: benefits and utilization. Diabetes Educ. 2006 Nov-Dec;32(6):835-6, 844-7. doi: 10.1177/0145721706295873. No abstract available.

  PMID: 17102152 BACKGROUND

• Yoo HJ, An HG, Park SY, Ryu OH, Kim HY, Seo JA, Hong EG, Shin DH, Kim YH, Kim SG, Choi KM, Park IB, Yu JM, Baik SH. Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes. Diabetes Res Clin Pract. 2008 Oct;82(1):73-9. doi: 10.1016/j.diabres.2008.06.015. Epub 2008 Aug 12.

  PMID: 18701183 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Hugh D Tildesley, MD

  Providence Health Care, University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: July 15, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2011
• Last Updated: September 11, 2014

Record last verified: 2014-09

Locations

CA (1)