NCT02185755

Brief Summary

Managing blood sugar levels is important for patients with type 2 diabetes (T2DM) to minimize health problems and complications. One way for patients to notify doctors and receive feedback about their blood sugar management is through an online system. As Internet-based glucose monitoring systems (IBGMS) have already been shown to be effective, the investigators hypothesize that IBGMS is effective as an intervention even when limiting feedback to non-medicine related changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

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

July 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

July 7, 2014

Last Update Submit

September 18, 2023

Conditions

Type 2 Diabetes Mellitus

Keywords

Internet-Based Glucose Monitoring SystemType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c Levels before and after intervention

    Compare HbA1c Levels before and after intervention for both arms, as well as the difference in HbA1c Levels between arms.

    6 months

Secondary Outcomes (3)

  • 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 months

  • HbA1c levels remain at 8% or higher

    3 months

Study Arms (2)

Internet-Based Glucose Monitoring System

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 provide feedback limited to non-medicine related comments and suggestions.

Other: Internet-Based Glucose Monitoring System

Normal Medication Positive Control

OTHER

The subjects will be prescribed a new medication as appropriate for normal therapy. This group will receive no biweekly feedback nor require to report online, but will see the endocrinologist every 3 months up to 6 months.

Drug: Normal Medication Positive Control

Interventions

Internet-Based Glucose Monitoring SystemOTHER
Also known as: Internet Blood Glucose Monitoring System, Remote Blood Glucose Monitoring System
Internet-Based Glucose Monitoring System
Normal Medication Positive ControlDRUG
Normal Medication Positive Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes patients being treated with oral hypoglycemic agents
  • HbA1c \> 8%
  • Willingness to test blood glucose levels a minimum of 3 times daily
  • Willingness to be trained on using the Internet-Based Glucose Monitoring System
  • Willingness to be randomized
  • Trained in self-blood glucose monitoring
  • Internet access on a computer
  • No prior use or training on IBGMS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Hugh Tildesley Inc.

Vancouver, British Columbia, V6E1M7, 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: 16371630BACKGROUND

  • 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: 9742976BACKGROUND

  • 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: 18937550BACKGROUND

  • 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: 17102152BACKGROUND

  • Tildesley HD, Mazanderani AB, Ross SA. Effect of Internet therapeutic intervention on A1C levels in patients with type 2 diabetes treated with insulin. Diabetes Care. 2010 Aug;33(8):1738-40. doi: 10.2337/dc09-2256.

    PMID: 20668152BACKGROUND

  • Cho JH, Chang SA, Kwon HS, Choi YH, Ko SH, Moon SD, Yoo SJ, Song KH, Son HS, Kim HS, Lee WC, Cha BY, Son HY, Yoon KH. Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30-month follow-up study for diabetes management with a ubiquitous medical care system. Diabetes Care. 2006 Dec;29(12):2625-31. doi: 10.2337/dc05-2371.

    PMID: 17130195BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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
Medical Director

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 10, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

CA(1)