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

This study has been completed.
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: August 16, 2017
Last verified: August 2017
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    The primary outcome of interest is absolute decrease in A1c by end of 3 months.


Secondary Outcome Measures:
  • Number of Participants Reaching Target of HbA1c ≤ 7% [ Time Frame: 3 months ]
    Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.

  • Change in Average Participation Satisfaction [ Time Frame: 3 months ]
    The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.

  • Number of Participants With Hypoglycemia [ Time Frame: 3 months ]
    Number of participants had hypoglycemia during the trial period

  • Time Health Care Providers and Subjects Spend on Managing the Insulin Titration [ Time Frame: 3 months ]
    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
Study Completion Date: October 2015
Primary Completion Date: October 2015 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

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
Results First Received: April 20, 2017
Last Updated: August 16, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017