Type II Diabetes
Conditions
Keywords
Diabetes, diabetes technologies, telemedicine
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.
Interventions
DEVICETablet Computer
Sponsors
Massachusetts Institute of Technology
Joslin Diabetes Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control as Determined by the Change in Absolute HbA1c Level | 3 months | The primary outcome of interest is absolute decrease in A1c by end of 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reaching Target of HbA1c ≤ 7% | 3 months | Secondary outcomes will include % of participants reaching glycemic target of A1c≤7. |
| Change in Average Participation Satisfaction | 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, 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 | 3 months | Number of participants had hypoglycemia during the trial period |
| Time Health Care Providers and Subjects Spend on Managing the Insulin Titration | 3 months | time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Tablet Computer | 20 |
| 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 16.04 | 53.3 years STANDARD_DEVIATION 1.88 | 53.52 years STANDARD_DEVIATION 13.76 |
| Region of Enrollment United States | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Glycemic Control as Determined by the Change in Absolute HbA1c Level | -3.16 Percent A1C | Standard Deviation 1.54 |
| Control Group | Glycemic Control as Determined by the Change in Absolute HbA1c Level | -2.00 Percent A1C | Standard Deviation 2.03 |
Secondary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Average Participation Satisfaction | 10.1 Scores on a scale | Standard Deviation 11.68 |
| Control Group | Change in Average Participation Satisfaction | 2.05 Scores on a scale | Standard Deviation 6.45 |
Secondary
Number of Participants Reaching Target of HbA1c ≤ 7%
Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Number of Participants Reaching Target of HbA1c ≤ 7% | 8 Participants |
| Control Group | Number of Participants Reaching Target of HbA1c ≤ 7% | 5 Participants |
Secondary
Number of Participants With Hypoglycemia
Number of participants had hypoglycemia during the trial period
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Number of Participants With Hypoglycemia | 3 Participants |
| Control Group | Number of Participants With Hypoglycemia | 1 Participants |
Secondary
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Time Health Care Providers and Subjects Spend on Managing the Insulin Titration | 108 min | Standard Deviation 41 |
| Control Group | Time Health Care Providers and Subjects Spend on Managing the Insulin Titration | 80 min | Standard Deviation 51 |