Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01698528
First received: October 1, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine if using a diabetes management technology system, including a tablet computer, to track diabetes care and communicate with a clinician coach (a doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and safer for people with type 2 diabetes. Hypothesis: The use of a diabetes management technology system with a clinician coach helps more individuals starting basal insulin achieve better glycemic control with less hypoglycemia compared with standard clinical practice at Joslin Diabetes Center.


Condition Intervention
Type II Diabetes
Device: Tablet Computer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration

Resource links provided by NLM:


Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • Glycemic control as determined by the change in absolute HbA1c level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The primary outcome of interest is absolute decrease in A1c by end of 3 months.


Secondary Outcome Measures:
  • Glycemic control as defined by reaching glycemic target of HbA1c ≤ 7% [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Secondary outcomes will include % reaching glycemic target of A1c≤7.

  • Patient Satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The volunteer's satisfaction with their diabetes care will be measured before and after the study

  • Frequency of hypoglycemia [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    frequency for hypoglycemia during the study period

  • time health care providers and subjects spend on managing the insulin titration [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes


Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group
The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.
Device: Tablet Computer
Other Name: Toshiba tablet computer
No Intervention: Control Group
The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • 18 years or older
  • Has type 2 diabetes, starting on basal insulin therapy
  • Hemoglobin A1c between 9-14%
  • Has Wi-Fi internet connection at home
  • Is willing to monitor blood glucose at least once per day
  • Is willing to inject and self-titrate insulin dose
  • Able to read and communicate in English proficiently

Exclusion:

  • Has severe visual impairment impacting visual acuity
  • Has severe hearing impairment impacting communication
  • Has Type 1 diabetes
  • Pregnant or lactating women
  • Alcohol dependency
  • Require multiple daily insulin injections
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698528

Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Massachusetts Institute of Technology
Investigators
Principal Investigator: William Hsu, M.D. Joslin Diabetes Center
  More Information

No publications provided

Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01698528     History of Changes
Other Study ID Numbers: CHS 2012-18
Study First Received: October 1, 2012
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Joslin Diabetes Center:
Diabetes
diabetes technologies
telemedicine

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014