Impact of Web-based Care Management for Poorly Controlled Type 2 Diabetes Mellitus: a Randomized, Controlled Trial

NCT01960062 | Withdrawn

• 1 other identifier: GA-11NYate-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Between October 1 and November 30, 2011, participants will be enrolled in this study comparing the use of MyLink web-based care with usual CPS care. Patients age 18- 74 with HbA1c ≥ 9% in the last 12 months will be identified. It is expected that approximately 32 people (16 per group) will participate in the study. Once eligible patients are found, they will be randomly assigned (like the flip of a coin) to usual care with the CPS or usual care with the CPS plus web-based care using the MyLink software. Participants using the software will agree to upload their glucometer measurements using the software every 2- 4 weeks. Following the receipt of the glucometer data, either electronically from intervention group participants or verbally from the control group participants, medications/ doses will be adjusted by the pharmacist as needed to achieve HbA1c goals. Participants in both groups will receive a follow-up HbA1c 2-4 months after enrollment to see if there were any significant changes in HbA1c between groups.

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes; web-based; software; device

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c

  2-4 months

Secondary Outcomes (2)

• Hemoglobin A1c<9

  2-4 months

• Office visit time

  2-4 months

Study Arms (2)

Control

NO INTERVENTION

Diabetes care with primary care practitioner supplemented with clinical pharmacy specialist

Intervention

EXPERIMENTAL

Diabetes care with primary care practitioner and clinical pharmacy specialist, with the aid of a diabetes software and device to upload glucometer results from home

Device: Diabetes software and device

Interventions

Diabetes software and device DEVICE

USB cord, CD-rom, and application to allow communication with provider

Intervention

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving care from a PCP at the specified KPGA medical centers
• years of age
• Type 2 Diabetes Mellitus (DM)
• Treated with insulin or willing to start insulin therapy
• Most recent HbA1c in the previous 12 months ≥ 9%
• Internet capability
• Actively enrolled or willing to enroll on www.kp.org
• English speaking

You may not qualify if:

• Having received care from an endocrinology specialty physician or Hospice/ Palliative Care within the last 3 months
• Enrolled in another research study
• Using an insulin pump
• Type 1 DM

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Georgia Region

Atlanta, Georgia, 30305, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Naomi Yates, PharmD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 10, 2013
• Study Start: October 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 19, 2014

Record last verified: 2014-03

Locations

US (1)