Type 2 Diabetes MellitusNCT03090464
A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 46 sites in United States.
Trial summary
Type 2 diabetes mellitus is a complex, chronic disease that requires a comprehensive treatment plan aimed at meeting multitude therapeutic targets associated with micro- and macro-vascular risk reduction. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Use of digital disease management tool
- How many people
- 328 participants
- Where
- 46 sitesUnited States
- Study dates
- 8 May 2017to 21 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.
Who may be able to join
- Provision of written informed consent;
- Diagnosed with T2DM;
- Male or female aged >/= 18 years at time of consent;
- Treatment with 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment;
- Own or have access to a smart phone with internet access and have access to the internet via a tablet or personal computer at least once a day;
- HbA1c levels must be obtained at the enrollment visit or up to 14 days prior to Visit 1 and must be >/=7.5% and </=11.0%. Most of the hbA1c values obtained within the past 9 months must also be within this range;
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- Body mass index >/= 25 and </=55 kg/mm2 within the last 3 months;
- Ability to communicate in English;
- Judged by their primary care physician to have suitable hearing, vision, manual dexterity, ability to understand instructions, and ability to use and understand smart phone and internet applications;
- Negative pregnancy test for female subjects of childbearing potential.
Who cannot join
- Pregnancy;
- Insulin use at baseline;
- Current use of a smart phone- or web portal-based tool designed to help with management of T2DM;
- History of Type 1 diabetes or ketoacidosis;
- Currently taking weight loss medication;
- Involvement in the planning and/or conduct of this study;
- Previous enrollment in the present study;
- Participation in a clinical study with an investigational product or a disease state management program during the last 30 days;
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Research Site
Albuquerque, New Mexico, 87102
Research Site
Birmingham, Alabama, 35209
Research Site
Birmingham, Alabama, 35216
Research Site
Brooklyn, New York, 11235
Research Site
Burke, Virginia, 22015
Research Site
Charleston, South Carolina, 29407
Research Site
Colorado Springs, Colorado, 80906
Research Site
Cooper City, Florida, 33024
Research Site
DeLand, Florida, 32720
Research Site
Downingtown, Pennsylvania, 19335
Research Site
Evanston, Illinois, 60201
Research Site
Federal Way, Washington, 98003
Research Site
Franklin, Ohio, 45005
Research Site
Greensboro, North Carolina, 27410
Research Site
Greer, South Carolina, 29651
Research Site
Hialeah, Florida, 33012
Research Site
Houston, Texas, 77040
Research Site
Houston, Texas, 77058
Reserarch Site
Jacksonville, Florida, 32277
Research Site
Lake City, Florida, 32055
Research Site
Lampasas, Texas, 76550
Research Site
Las Vegas, Nevada, 89128
Research Site
Lexington, Kentucky, 40503
Research Site
Lincoln, California, 95648
Research Site
Manassas, Virginia, 20110
Resezrch Site
Montclair, California, 91763
Research Site
Myrtle Beach, South Carolina, 29588
Research Site
New Windsor, New York, 12553
Research Site
North Hollywood, California, 91606
Research Site
Olympia, Washington, 98502
Research Site
Omaha, Nebraska, 68134
Research Site
Ormond Beach, Florida, 32174
Research Site
Oxon Hill, Maryland, 20745
Research Site
Pembroke Pines, Florida, 33026
Research Site
Peoria, Arizona, 85381
Research Site
Plano, Texas, 75024
Research Site
Port Orange, Florida, 32127
Research Site
Richmond, Virginia, 23235
Research Site
Salt Lake City, Utah, 84107
Research Site
Spartanburg, South Carolina, 29301
Research Site
Spring Valley, California, 91978
Research Site
Surprise, Arizona, 85374
Research Site
Tampa, Florida, 33634
Research Site
Tullahoma, Tennessee, 37388
Research Site
Van Nuys, California, 91405
Research Site
Westfield, New York, 14787
About this study
Official title: A Real-world, Point-of-care, Randomized, Parallel Group, Open, 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus
Type 2 diabetes mellitus is a complex, chronic disease that requires a comprehensive treatment plan aimed at meeting multitude therapeutic targets associated with micro- and macro-vascular risk reduction. There is evidence that patient support in various forms can have a significant positive impact on adherence to treatment and the meeting of targets in patients with type 2 diabetes mellitus. The purpose of this study is to evaluate if the use of a digital disease management tool (Smart phone- web portal-based tool), in addition to Standard of Care for T2DM, will improve glycemic control. Other variables important in T2DM (such as weight, blood pressure, and lipid levels), will also be evaluated along with patient-reported outcomes, such as satisfaction with treatment and adherence to their antihyperglycemic treatment. Study duration is 6 months
Read the detailed description
Type 2 diabetes mellitus (T2DM) is a complex, chronic disease that requires a comprehensive treatment plan aimed at meeting multitude therapeutic targets associated with micro- and macro-vascular risk reduction. There is evidence that patient support in various forms can have a significant positive impact on adherence to treatment and the meeting of targets in patients with type 2 diabetes mellitus. A digital disease-management tool, smart phone- and web-based portal, has been developed that incorporates the following features aimed at improving patient and population outcomes:
Treatment management to help patients remember to take medications and track adherence; Goal setting, including medical nutrition therapy, appropriately prescribed physical activity, and weight loss for those patients who are overweight or obese; Tracking and data collection for blood glucose, weight, and exercise, as entered by the patient or automatically for activity via Bluetooth pedometer or activity tracker; Assessments to capture patient beliefs in order to tailor personalized content to individual needs; educational and motivational content in the form of short messages, text, and videos covering T2DM and its treatment, and lifestyle advice; Web portals to display collected data back to the patient and healthcare practitioner in real-time to allow better and timely management of diabetes.
This tool is added to the Standard of Care for T2DM. Data are collected for patients utilizing this tool, compared with those who are not. Clinical assessments as part of the Standard of Care are collected, as well as standard Patient Reported Outcomes for this disease.
Glycemic control is considered to be the goal of a T2DM disease management plan.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Use of digital disease management tool
- Keywords
- Type 2 diabetes mellitus, Digital disease management, T2DM, Hyperglycemia, Diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of digital disease management toolOther
The purpose of the study is to evaluate if the provision of a digital disease management tool, in addition to SOC for T2DM, will improve glycemic control. The impact of the tool will be assessed in comparison to a Control group who will receive SOC alone. All participants will complete the PRO assessments. This is a real world study carried out at the point of care.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | Participants have standard of care with no access to digital disease management tool | |
| SOC + digital disease management | Participants have access to the digital disease management tool in addition to standard of care Receives: Other: Use of digital disease management tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to end of study (Month 6) in HbA1c levels
Assessed from blood samples taken at visits per standard of care
Measured: 6 months
Secondary outcomes (3)
Percentage of patients who achieve HbA1c levels <7% at Month 6
Assessed from blood samples taken at visits per standard of care
Measured: 6 Months
Mean change in body weight (kg) from baseline to Month 6
Measures taken at visits per standard of care
Measured: 6 Months
Proportion of patients in both cohorts who intensify antihyperglycemic treatment from Visit 1
Defined as an increase in dose or addition of a new antihyperglycemic agent not received at baseline
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start8 May 2017
- Primary completion21 May 2018
- Study completion21 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Sooben, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090464
- Sponsor's protocol ID
- D1841C00004
- Status last verified
- May 2019
- First submitted
- 20 Mar 2017
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world, Point-of-care, Randomized, Parallel Group, Open, 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03090464
- Acronym / sponsor ID
- D1841C00004
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, Digital disease management, T2DM, Hyperglycemia, Diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 8 May 2017 (actual)
- Primary completion
- 21 May 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 2 diabetes mellitus is a complex, chronic disease that requires a comprehensive treatment plan aimed at meeting multitude therapeutic targets associated with micro- and macro-vascular risk reduction. There is evidence that patient support in various forms can have a significant positive impact on adherence to treatment and the meeting of targets in patients with type 2 diabetes mellitus. The purpose of this study is to evaluate if the use of a digital disease management tool (Smart phone- web portal-based tool), in addition to Standard of Care for T2DM, will improve glycemic control. Other variables important in T2DM (such as weight, blood pressure, and lipid levels), will also be evaluated along with patient-reported outcomes, such as satisfaction with treatment and adherence to their antihyperglycemic treatment. Study duration is 6 months
Detailed description
Type 2 diabetes mellitus (T2DM) is a complex, chronic disease that requires a comprehensive treatment plan aimed at meeting multitude therapeutic targets associated with micro- and macro-vascular risk reduction. There is evidence that patient support in various forms can have a significant positive impact on adherence to treatment and the meeting of targets in patients with type 2 diabetes mellitus. A digital disease-management tool, smart phone- and web-based portal, has been developed that incorporates the following features aimed at improving patient and population outcomes:
Treatment management to help patients remember to take medications and track adherence; Goal setting, including medical nutrition therapy, appropriately prescribed physical activity, and weight loss for those patients who are overweight or obese; Tracking and data collection for blood glucose, weight, and exercise, as entered by the patient or automatically for activity via Bluetooth pedometer or activity tracker; Assessments to capture patient beliefs in order to tailor personalized content to individual needs; educational and motivational content in the form of short messages, text, and videos covering T2DM and its treatment, and lifestyle advice; Web portals to display collected data back to the patient and healthcare practitioner in real-time to allow better and timely management of diabetes.
This tool is added to the Standard of Care for T2DM. Data are collected for patients utilizing this tool, compared with those who are not. Clinical assessments as part of the Standard of Care are collected, as well as standard Patient Reported Outcomes for this disease.
Glycemic control is considered to be the goal of a T2DM disease management plan.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | – | –Participants have standard of care with no access to digital disease management tool |
| SOC + digital disease management | – | Other: Use of digital disease management toolParticipants have access to the digital disease management tool in addition to standard of care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.
Key inclusion criteria (10 listed)
- Provision of written informed consent;
- Diagnosed with T2DM;
- Male or female aged >/= 18 years at time of consent;
- Treatment with 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment;
- Own or have access to a smart phone with internet access and have access to the internet via a tablet or personal computer at least once a day;
Key exclusion criteria (8 listed)
- Pregnancy;
- Insulin use at baseline;
- Current use of a smart phone- or web portal-based tool designed to help with management of T2DM;
- History of Type 1 diabetes or ketoacidosis;
- Currently taking weight loss medication;
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 |
|---|---|---|
| Use of digital disease management toolThe purpose of the study is to evaluate if the provision of a digital disease management tool, in addition to SOC for T2DM, will improve glycemic control. The impact of the tool will be assessed in comparison to a Control group who will receive SOC alone. All participants will complete the PRO assessments. This is a real world study carried out at the point of care. | Other | SOC + digital disease management |
Primary outcome
Change from baseline to end of study (Month 6) in HbA1c levels
Time frame: 6 months
Assessed from blood samples taken at visits per standard of care
3 secondary outcomes
Percentage of patients who achieve HbA1c levels <7% at Month 6
Time frame: 6 Months
Mean change in body weight (kg) from baseline to Month 6
Time frame: 6 Months
Proportion of patients in both cohorts who intensify antihyperglycemic treatment from Visit 1
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Kevin Sooben study chair
AstraZeneca
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 46 sites 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 10 inclusion and 8 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 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline to end of study (Month 6) in HbA1c levels (time frame: 6 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 9 May 2019.