NCT01415271

Brief Summary

The incidence of type 2 diabetes in long term care facilities has been approximated at 25% with barriers to treatment including untimely access to a specialist and improper/poor adherence to insulin regimes. This 3 month trial will investigate the efficacy of improving overall glycemic control by using an internet blood glucose reporting system to facilitate bi-weekly consultations between long term care facility patients with type 2 diabetes and an endocrinologist.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable type-2-diabetes

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

August 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

August 10, 2011

Last Update Submit

August 10, 2015

Conditions

Type 2 Diabetes

Keywords

diabetesA1cinternetlong term care

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Hemoglobin A1c will be measure at 0 and 3 months to determine the efficacy of the internet blood glucose monitoring system as measured by change in glycemic control.

    0 and 3 months

Secondary Outcomes (3)

  • Staff satisfaction

    3 months

  • Frequency of Self-Monitoring

    3 months

  • unplanned hospitalizations

    3 months

Study Arms (1)

Internet Intervention

EXPERIMENTAL
Other: Internet Communication

Interventions

Internet CommunicationOTHER

bi-weekly communication of blood sugars using an internet platform between patients with type 2 diabetes and an endocrinologist

Internet Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Type II diabetes mellitus patients at Point Grey Private Hospital
  • Trained in self-blood glucose monitoring
  • Willingness to test blood glucose levels a minimum of 3 times daily
  • Willingness to be trained on IBGMS

You may not qualify if:

  • Patients with medical conditions that may affect their study participation or results will be excluded.
  • Patients currently being treated with steroid medication
  • Patients that have impaired liver function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrine Research Society

Vancouver, British Columbia, V6E 1M7, Canada

Location

Related Publications (7)

  • Clement M and Leung F. Diabetes and the Frail Elderly in Long-term Care. Can J Diabetes. 2009;33(2):114-121.

    BACKGROUND

  • Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

    PMID: 8366922BACKGROUND

  • 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

  • American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care. 2008 Jan;31 Suppl 1:S12-54. doi: 10.2337/dc08-S012. No abstract available.

    PMID: 18165335BACKGROUND

  • Karter AJ, Ackerson LM, Darbinian JA, D'Agostino RB Jr, Ferrara A, Liu J, Selby JV. Self-monitoring of blood glucose levels and glycemic control: the Northern California Kaiser Permanente Diabetes registry. Am J Med. 2001 Jul;111(1):1-9. doi: 10.1016/s0002-9343(01)00742-2.

    PMID: 11448654BACKGROUND

  • 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

  • Tildesley HD, Mazanderani, AB, Chan, JHM et al. Efficacy of A1c Reduction Using Internet Intervention in Patients with Type 2 Diabetes Treated with Insulin. Can J Diabetes. 2011; 35(3): 250-253.

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hugh Tildesley

    Providence Health Care, University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 11, 2011

Study Start

October 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

CA(1)