3-Month Trial Observation of A1c Change

NCT ID: NCT01415271

Last Updated: 2015-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Purpose: This project will investigate the benefits (as measured by change in the primary outcome measure hemoglobin A1c) of bi-weekly reporting of blood sugar values for patients with type 2 diabetes in long term care facilities.

Hypothesis: Our hypothesis is bi-weekly reporting will result in a reduction in A1c after 3 months.

Justification: Elevated A1c values increase risk of health complications for people with type 2 diabetes.

Objectives: Improved type 2 diabetes management for patients in long term care facilities.

Research Methods: Patients who meet the inclusion / exclusion criteria and are interested in participating in the study will self-identify to the research coordinator. Consent will be done in person with any questions answered. Strips and blood glucose meters will be provided. Blood glucose values and testing frequency will be recorded using the internet reporting system Heath-e-Connect. HbA1c, serum creatinine and demographic data will be collected at 0 and 3 months to determine effect of bi-weekly remote communication of blood glucose with an endocrinologist.

Statistical Analysis: HbAlc values at 0 and 3 months will be compared using an unpaired t-test to measure the effect of the intervention

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Internet Intervention

Group Type EXPERIMENTAL

Internet Communication

Intervention Type OTHER

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

Interventions

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Internet Communication

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endocrine Research Society

OTHER

Sponsor Role lead

Responsible Party

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Dr. Hugh Tildesley

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hugh Tildesley

Role: PRINCIPAL_INVESTIGATOR

Providence Health Care, University of British Columbia

Locations

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Endocrine Research Society

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 8366922 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17102152 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18165335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11448654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18937550 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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Point Grey Trial

Identifier Type: -

Identifier Source: org_study_id

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