Type II Diabetes MellitusNCT02749435
A Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus
An observational study of Type II Diabetes Mellitus, run by AstraZeneca at 14 sites in United Kingdom.
Trial summary
A real-world, point-of-care, randomized, parallel group, open, 6-month clinical study to evaluate if the provision of a digital disease management tool improves glycaemic control in participants with type 2 diabetes mellitus (T2DM), as measured by change from baseline to End of Study (Month 6) in glycosylated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- Use of digital disease management tool in participants with T2DM
- How many people
- 57 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- 3 May 2016to 13 Oct 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a prior diagnosis of Type II Diabetes Mellitus.
Who may be able to join
- For inclusion in the study participants must fulfill the following criteria:
- Provision of written informed consent prior to any study-specific procedures.
- Female or male aged ≥18 years at time of consent.
- Diagnosed with T2DM.
- Treatment with one or more non-insulin antihyperglycaemic medication(s) for at least 6 months prior to enrolment
- Own/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. At the HCP's discretion, a patient may be without access to their smart phone service, data connection, and internet access for a period of time that should be ≤2 consecutive weeks
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- HbA1c levels ≥8.0% and ≤11.0% within the last 6 months. If more than 1 value is available during the 6-month time period, all values must be within this range
- Body mass index (BMI) ≥25 and ≤55 kg/m2 within the last 3 months
- Ability to communicate in English
- Judged by their HCP 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 (urine or serum) for female patients of childbearing potential
Who cannot join
- Participants cannot enter the study if any of the following exclusion criteria are fulfilled:
- Pregnancy
- Insulin use at baseline
- Current use of a smart phone- or web portal-based tool to help with management of T2DM
- History of type I diabetes or ketoacidosis
- Currently taking a weight loss medication
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- Involvement in the planning and/or conduct of the study (applies to both AZ staff and/or staff and affiliates at the study site)
- Previous enrolment 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
14 sites in 1 country.
14 sites in 1 country
United Kingdom14 sites
Research Site
Bonnyrigg, Midlothian
Research Site
Cardiff, Cardiff [Caerdydd Gb-crd]
Research Site
Dundee, Angus
Research Site
Edinburgh, Midlothian
Research Site
Fife
Research Site
Flintshire, Flintshire [Sir Y Fflint Gb-ff
Research Site
Leicester
Research Site
London, Harrow
Research Site
London
Research Site
Manchester, Lancashire
Research Site
Mid Glamorgan, Mid Glamorgan
Research Site
Muirhead, Dundee City
Research Site
Oldham, Manchester
Research Site
Stockport
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
A real-world, point-of-care, randomized, parallel group, open, 6-month clinical study to evaluate if the provision of a digital disease management tool improves glycaemic control in participants with type 2 diabetes mellitus (T2DM), as measured by change from baseline to End of Study (Month 6) in glycosylated haemoglobin (HbA1c) levels. Clinical assessments for this study will be conducted as part of normal, standard care. The main objective of this study is to evaluate the effect of adding this tool to participants' current standard care for T2DM on glycaemic control, other variables of importance in T2DM (eg, weight, blood pressure, and lipid levels), and participant-reported outcomes (PROs), such as satisfaction with treatment and adherence to their antihyperglycaemic treatment
Read the detailed description
The purpose of this study is to evaluate if the provision of a digital disease management tool in addition to standard care for T2DM, will improve glycaemic control. This is an open design study, in which the patients will be aware of the guidance they are receiving via the provided support tool. Study duration of 6 months has been chosen, as a reasonable amount of time to evaluate the tool. Glycaemic control is considered to be the goal of a T2DM disease management plan. In T2DM, long-term goals may not be achieved because participants fail to adhere to their management plan after an initial period of compliance. The study will compare the group receiving the digital disease management tool added to standard care for T2DM to a concurrent control group receiving standard care. Standard of Care cohort: Participants will have standard care with no access to the digital disease management tool. Clinical assessments for this study will be conducted as part of normal, standard care. Participants in the Standard of Care + digital disease management cohort will be taken through their standard T2DM management plan by their HCP (Health Care Provider) and trained in the use of the digital disease management tool. All participants will complete the PRO assessments. This study also aims at helping the health care practitioners and managed care providers to make evidence-based decisions about how to improve patient self-management of their diabetes. Participants diagnosed with T2DM and on one or more non-insulin antihyperglycaemic medications will be offered participation in the study at their point of care. Participants in the Standard of Care cohort will be taken through their T2DM management plan with their HCP per standard care. It is not anticipated that the use of this patient tool will be associated with any increase in risk to participating patients. The study will be performed in accordance with ethical principles that are consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP), applicable regulatory requirements, and the AZ policy of bioethics.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- Use of digital disease management tool in participants with T2DM
- Keywords
- Digital disease management tool, Type 2 diabetes mellitus/ T2DM, HbA1c, Standard care, PRO questionnaires, Smart phone/ personal computer with internet access
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of digital disease management tool in participants with T2DMOther
The purpose of this study is to evaluate if the provision of a digital disease management tool in addition to standard care for T2DM, will improve glycaemic control. The impact of the tool will be assessed in comparison to a Control group who will receive standard care alone. All participants will complete the PRO assessments. This is a real-world study carried out at the point of care intended to assist health care practitioners and managed care providers to make evidence-based decisions about how to improve participant self-management of their diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care + digital disease management cohort | Participants will have access to the smart phone- and web portal-based digital disease management tool in addition to standard care. Receives: Other: Use of digital disease management tool in participants with T2DM | |
| Standard of Care cohort | Participants will have standard care with no access to the digital disease management tool. Receives: Other: Use of digital disease management tool in participants with T2DM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from baseline to Month 6 in HbA1c
The primary outcome measure is the mean change from baseline to Month 6 in HbA1c. Mean changes from baseline to intermediate visits (if any occur) will also be determined.
Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.
Measured: From Baseline to 6 months
Secondary outcomes (3)
Proportion of participants who achieve HbA1c levels <7% at Month 6
Proportion of participants who achieve HbA1c levels <7% at Month 6
Measured: Month 6 of study participation
Mean change in Body weight (kg) from baseline to Month 6
Mean change in Body weight (kg) from baseline to Month 6.
Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.
Measured: From Baseline to 6 months
Proportion of patients in both cohorts who intensify antihyperglycaemic treatment from Visit 1
Proportion of participants in both cohorts who intensify antihyperglycaemic treatment from Visit 1, defined as an increase in dose or addition of a new antihyperglycaemic agent not received at baseline.
Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.
Measured: From Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start3 May 2016
- Primary completion13 Oct 2016
- Study completion13 Oct 2016
Why it stopped: The study was stopped due to lack of recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II 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
- Other
- Time perspective
- Other
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Manesh Saxena, Principal investigator, Barts and the London, Queen Mary School of Medicine and DentistryDeepak Bhatnagar, Principal investigator, Penine Acute Hospitals TrustAled Roberts, Principal investigator, Cardiff and Vale NHS Trust - University Hospital of WalesMelanie Davies, Principal investigator, Leicester General HospitalSee Kwok, Principal investigator, Barlow Medical CentreKeith Richardson, Principal investigator, Bridge House Medical CentreDeborah Wake, Principal investigator, Ninewells Hospital and Medical SchoolRuth Leese, Principal investigator, Muirhead Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749435
- Sponsor's protocol ID
- D1841C00002
- Status last verified
- Oct 2017
- First submitted
- 12 Apr 2016
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. 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
- NCT02749435
- Acronym / sponsor ID
- D1841C00002
- Conditions
- Type II Diabetes Mellitus
- Keywords
- Digital disease management tool, Type 2 diabetes mellitus/ T2DM, HbA1c, Standard care, PRO questionnaires, Smart phone/ personal computer with internet access
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was stopped due to lack of recruitment.
- Enrolment
- 57 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 3 May 2016 (actual)
- Primary completion
- 13 Oct 2016 (actual)
- Study completion
- 13 Oct 2016 (actual)
- First posted
- 25 Apr 2016 (estimated)
- 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.
A real-world, point-of-care, randomized, parallel group, open, 6-month clinical study to evaluate if the provision of a digital disease management tool improves glycaemic control in participants with type 2 diabetes mellitus (T2DM), as measured by change from baseline to End of Study (Month 6) in glycosylated haemoglobin (HbA1c) levels. Clinical assessments for this study will be conducted as part of normal, standard care. The main objective of this study is to evaluate the effect of adding this tool to participants' current standard care for T2DM on glycaemic control, other variables of importance in T2DM (eg, weight, blood pressure, and lipid levels), and participant-reported outcomes (PROs), such as satisfaction with treatment and adherence to their antihyperglycaemic treatment
Detailed description
The purpose of this study is to evaluate if the provision of a digital disease management tool in addition to standard care for T2DM, will improve glycaemic control. This is an open design study, in which the patients will be aware of the guidance they are receiving via the provided support tool. Study duration of 6 months has been chosen, as a reasonable amount of time to evaluate the tool. Glycaemic control is considered to be the goal of a T2DM disease management plan. In T2DM, long-term goals may not be achieved because participants fail to adhere to their management plan after an initial period of compliance. The study will compare the group receiving the digital disease management tool added to standard care for T2DM to a concurrent control group receiving standard care. Standard of Care cohort: Participants will have standard care with no access to the digital disease management tool. Clinical assessments for this study will be conducted as part of normal, standard care. Participants in the Standard of Care + digital disease management cohort will be taken through their standard T2DM management plan by their HCP (Health Care Provider) and trained in the use of the digital disease management tool. All participants will complete the PRO assessments. This study also aims at helping the health care practitioners and managed care providers to make evidence-based decisions about how to improve patient self-management of their diabetes. Participants diagnosed with T2DM and on one or more non-insulin antihyperglycaemic medications will be offered participation in the study at their point of care. Participants in the Standard of Care cohort will be taken through their T2DM management plan with their HCP per standard care. It is not anticipated that the use of this patient tool will be associated with any increase in risk to participating patients. The study will be performed in accordance with ethical principles that are consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP), applicable regulatory requirements, and the AZ policy of bioethics.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care + digital disease management cohort | – | Other: Use of digital disease management tool in participants with T2DMParticipants will have access to the smart phone- and web portal-based digital disease management tool in addition to standard care. |
| Standard of Care cohort | – | Other: Use of digital disease management tool in participants with T2DMParticipants will have standard care with no access to the digital disease management tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a prior diagnosis of Type II Diabetes Mellitus.
Key inclusion criteria (11 listed)
- Provision of written informed consent prior to any study-specific procedures.
- Female or male aged ≥18 years at time of consent.
- Diagnosed with T2DM.
- Treatment with one or more non-insulin antihyperglycaemic medication(s) for at least 6 months prior to enrolment
- Own/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. At the HCP's discretion, a patient may be without access to their smart phone service, data connection, and internet access for a period of time that should be ≤2 consecutive weeks
Key exclusion criteria (9 listed)
- Participants cannot enter the study if any of the following exclusion criteria are fulfilled:
- Pregnancy
- Insulin use at baseline
- Current use of a smart phone- or web portal-based tool to help with management of T2DM
- History of type I diabetes or ketoacidosis
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 tool in participants with T2DMThe purpose of this study is to evaluate if the provision of a digital disease management tool in addition to standard care for T2DM, will improve glycaemic control. The impact of the tool will be assessed in comparison to a Control group who will receive standard care alone. All participants will complete the PRO assessments. This is a real-world study carried out at the point of care intended to assist health care practitioners and managed care providers to make evidence-based decisions about how to improve participant self-management of their diabetes. | Other | Standard of Care + digital disease management cohort, Standard of Care cohort |
Primary outcome
Mean Change from baseline to Month 6 in HbA1c
Time frame: From Baseline to 6 months
The primary outcome measure is the mean change from baseline to Month 6 in HbA1c. Mean changes from baseline to intermediate visits (if any occur) will also be determined. Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.
3 secondary outcomes
Proportion of participants who achieve HbA1c levels <7% at Month 6
Time frame: Month 6 of study participation
Mean change in Body weight (kg) from baseline to Month 6
Time frame: From Baseline to 6 months
Proportion of patients in both cohorts who intensify antihyperglycaemic treatment from Visit 1
Time frame: From Baseline to 6 months
Results and safety
The study was stopped early (reason given: The study was stopped due to lack of recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- D1841C00002 SynopsisLink provided by the sponsor.
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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.
Manesh Saxena principal investigator
Barts and the London, Queen Mary School of Medicine and Dentistry
Deepak Bhatnagar principal investigator
Penine Acute Hospitals Trust
Aled Roberts principal investigator
Cardiff and Vale NHS Trust - University Hospital of Wales
14 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 II Diabetes Mellitus, run by AstraZeneca at 14 sites in United Kingdom.
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 11 inclusion and 9 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: stopped early, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom. 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 was stopped early (reason given: The study was stopped due to lack of recruitment.). Results are not available in the source record.
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?
Mean Change from baseline to Month 6 in HbA1c (time frame: From Baseline to 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 16 Oct 2017.