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

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.

Study Overview

• Status: Completed
• Conditions: Type II Diabetes
• Intervention / Treatment: Device: Tablet Computer

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Control as Determined by the Change in Absolute HbA1c Level	The primary outcome of interest is absolute decrease in A1c by end of 3 months.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reaching Target of HbA1c ≤ 7%	Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.	3 months
Change in Average Participation Satisfaction	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, with higher scores indicating greater satisfaction. 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.	3 months
Number of Participants With Hypoglycemia	Number of participants had hypoglycemia during the trial period	3 months
Time Health Care Providers and Subjects Spend on Managing the Insulin Titration	time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes	3 months

Collaborators and Investigators

• Sponsor: Joslin Diabetes Center
• Collaborators: Massachusetts Institute of Technology
• Investigators: Principal Investigator: William Hsu, M.D., Joslin Diabetes Center

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 1, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 3, 2012

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: September 28, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Diabetes; telemedicine; diabetes technologies
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CHS 2012-18