Effect of Internet Therapeutic Intervention on A1C Levels in Type 2 Diabetes Mellitus (DM)

NCT00814190 | Completed

• 1 other identifier: Internet Intervention in T2D
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Management of diabetes is an evolving challenge to health care professionals. The fluctuations of glucose levels over the lifetime of patients with diabetes can lead to complications such as nephropathy, neuropathy, retinopathy and cardiovascular diseases. Although diabetes is a chronic disease, it can be controlled with use of medications (pills or insulin), and/or changes in life-style and diet. These interventions are aimed at keeping the blood glucose levels normal or in the range of acceptable levels. An important aspect of diabetes care is the monitoring of blood glucose levels in order to assess the effectiveness of treatment and to modify the treatment to achieve the desirable glucose levels. Patients with type 2 DM treated with insulin are recommended to perform testing for their blood glucose levels; however, it often requires intervention by health professionals in order to prevent the immediate and serious complications of hyper or hypoglycemia. The frequent self-monitoring of blood glucose and effective interventions by the health professionals may eventually allow tighter control of blood glucose levels and delay or prevent the complications associated with diabetes. In this study, the investigators wish to evaluate the effect of an Internet based remote monitoring system that allows for patients to upload their blood glucose readings online and for the health care professional to view and provide feedback or therapeutic intervention. The Internet based system has the features of presenting the blood glucose readings according to the time of day and automatically calculates the daily average plus the standard deviation. A visual graph of the glucose readings over a 24-hour period is also generated for view. In addition, the doctor can give feedback by sending messages through the system. The patient's personal information is kept secure as outlined by the privacy policy of the Internet based system and only the doctor and the patient can view the uploaded glucose readings. The investigators propose that the standardized encounters using the Internet will improve the outcome of treatment for patients with type 2 DM.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes; Internet Therapeutic Intervention

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

• The secondary endpoints include severe hypoglycemia defined as requiring external aid, hospital admissions for any CVD related intervention, and adverse events such as unplanned hospitalizations for any cause that last more than 24 hours.

  6 months

Study Arms (2)

Internet Intervention

EXPERIMENTAL

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: Internet Intervention

Standard Care

NO INTERVENTION

This arm will receive standard care which includes self-blood glucose monitoring at least 3 times daily and visit to the endocrinologist at least once every 3 months.

Interventions

Internet Intervention 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: Remote Glucose Monitoring System

Internet Intervention

Eligibility Criteria

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

You may qualify if:

• Type 2 diabetes patients treated with insulin
• A1C 7-11%
• \>25 years of age
• Willingness to test blood glucose levels a minimum of 3 times daily
• Willingness to be randomized
• Trained in self blood glucose monitoring
• Internet Access

You may not qualify if:

• In addition patients with the potential to become pregnant or patients using medications known to influence control of diabetes (eg steroids systemic or inhaled) are excluded from the study.

Sponsors & Collaborators

• Endocrine Research Society: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (5)

• 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: 8366922 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

• 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

• 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: 11448654 BACKGROUND

• 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: 20668152 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 24, 2008
• Study Start: January 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 7, 2010

Record last verified: 2009-08

Locations

CA (1)