Type II DiabetesNCT01698528
Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration
A study testing Tablet Computer in people with Type II Diabetes, run by Joslin Diabetes Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- Tablet Computer
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Type II Diabetes
- Being tested
- Tablet Computer
- Keywords
- Diabetes, diabetes technologies, telemedicine
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet ComputerDevice
Also called Toshiba tablet computer
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Device: Tablet Computer |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
Number of Participants Reaching Target of HbA1c ≤ 7%
Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.
Measured: 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.
Measured: 3 months
Number of Participants With Hypoglycemia
Number of participants had hypoglycemia during the trial period
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Sponsor
- Investigators
- William Hsu, M.D., Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698528
- Sponsor's protocol ID
- CHS 2012-18
- Status last verified
- Sep 2018
- First submitted
- 1 Oct 2012
- Last updated
- 24 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration
- ClinicalTrials.gov ID
- NCT01698528
- Acronym / sponsor ID
- CHS 2012-18
- Conditions
- Type II Diabetes
- Keywords
- Diabetes, diabetes technologies, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- Oct 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Posted 14 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Tablet 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Has severe visual impairment impacting visual acuity
- Has severe hearing impairment impacting communication
- Has Type 1 diabetes
- Pregnant or lactating women
- Alcohol dependency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablet ComputerAlso: Toshiba tablet computer | Device | Intervention Group |
Primary outcome
Glycemic Control as Determined by the Change in Absolute HbA1c Level
Time frame: 3 months
The primary outcome of interest is absolute decrease in A1c by end of 3 months.
4 secondary outcomes
Number of Participants Reaching Target of HbA1c ≤ 7%
Time frame: 3 months
Change in Average Participation Satisfaction
Time frame: 3 months
Number of Participants With Hypoglycemia
Time frame: 3 months
Time Health Care Providers and Subjects Spend on Managing the Insulin Titration
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Hsu, M.D. principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet Computer in people with Type II Diabetes, run by Joslin Diabetes Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control as Determined by the Change in Absolute HbA1c Level (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.