Back to resultsEvaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration
Primary Purpose
Type II Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tablet Computer
Sponsored by
About this trial
This is an interventional supportive care trial for Type II Diabetes focused on measuring Diabetes, diabetes technologies, telemedicine
Eligibility 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
Sites / Locations
- Joslin Diabetes Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants Reaching Target of HbA1c ≤ 7%
Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.
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.
Number of Participants With Hypoglycemia
Number of participants had hypoglycemia during the trial period
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
Full Information
NCT ID
NCT01698528
First Posted
October 1, 2012
Last Updated
September 28, 2018
Sponsor
Joslin Diabetes Center
Collaborators
Massachusetts Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT01698528
Brief Title
Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration
Official Title
Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joslin Diabetes Center
Collaborators
Massachusetts Institute of Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes
Keywords
Diabetes, diabetes technologies, telemedicine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Tablet Computer
Other Intervention Name(s)
Toshiba tablet computer
Primary Outcome Measure Information:
Title
Glycemic Control as Determined by the Change in Absolute HbA1c Level
Description
The primary outcome of interest is absolute decrease in A1c by end of 3 months.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of Participants Reaching Target of HbA1c ≤ 7%
Description
Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.
Time Frame
3 months
Title
Change in Average Participation Satisfaction
Description
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.
Time Frame
3 months
Title
Number of Participants With Hypoglycemia
Description
Number of participants had hypoglycemia during the trial period
Time Frame
3 months
Title
Time Health Care Providers and Subjects Spend on Managing the Insulin Titration
Description
time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Hsu, M.D.
Organizational Affiliation
Joslin Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration
We'll reach out to this number within 24 hrs