MedPath

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

Not Applicable
Completed
Conditions
Type II Diabetes
Interventions
Device: Tablet Computer
Registration Number
NCT01698528
Lead Sponsor
Joslin Diabetes Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention GroupTablet ComputerThe 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.
Primary Outcome Measures
NameTimeMethod
Glycemic Control as Determined by the Change in Absolute HbA1c Level3 months

The primary outcome of interest is absolute decrease in A1c by end of 3 months.

Secondary Outcome Measures
NameTimeMethod
Number of Participants Reaching Target of HbA1c ≤ 7%3 months

Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.

Number of Participants With Hypoglycemia3 months

Number of participants had hypoglycemia during the trial period

Time Health Care Providers and Subjects Spend on Managing the Insulin Titration3 months

time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes

Change in Average Participation Satisfaction3 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, 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.

Trial Locations

Locations (1)

Joslin Diabetes Center

🇺🇸

Boston, Massachusetts, United States

© Copyright 2025. All Rights Reserved by MedPath