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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type II Diabetes

Intervention / Treatment
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* Device: Tablet Computer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br> <br> * Other names: Toshiba tablet computer;|
| No Intervention: Control Group<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, diabetes technologies, telemedicine