Clinical trial NCT02749435: A Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2016-04-25
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with a prior diagnosis of Type II Diabetes Mellitus.

Brief 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 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.

Eligibility criteria: Inclusion criteria:

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
* 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

Exclusion criteria:

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
* 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

Primary outcomes:
measure: Mean Change from baseline to Month 6 in HbA1c
timeFrame: From Baseline to 6 months
Secondary outcomes:
measure: Proportion of participants who achieve HbA1c levels <7% at Month 6
timeFrame: Month 6 of study participation
measure: Mean change in Body weight (kg) from baseline to Month 6
timeFrame: From Baseline to 6 months
measure: Proportion of patients in both cohorts who intensify antihyperglycaemic treatment from Visit 1
timeFrame: From Baseline to 6 months
Other outcomes:
measure: Number of times smart phone- and/or web portal-based tool accessed per patient
timeFrame: From Baseline to 6 months
measure: Mean percent change from baseline to Month 6 in SBP
timeFrame: From Baseline to 6 months
measure: Proportion of patients who achieve BP <140/90 mmHg at Month 6
timeFrame: From Baseline to 6 months
measure: Mean percent change from baseline to Month 6 in LDL-C
timeFrame: From Baseline to 6 months
measure: Proportion of patients who achieve LDL-C <100 mg/dL at Month 6
timeFrame: From Baseline to 6 months
measure: Length of time from first to last usage of smart phone- and/or web portal-based tool
timeFrame: From Baseline to 6 months
measure: Mean difference in primary care office visits between active and control group during the 6-month study period as reported in patient records (to examine potential differences in resource utilization)
timeFrame: From Baseline to 6 months
measure: Mean difference in Emergency Room visits between active and control groupduring the 6-month study period as reported by patients at the end of the study (to examine potential differences in resource utilization)
timeFrame: From Baseline to 6 months
measure: Change from baseline to Month 6 in Diabetes Treatment Satisfaction Questionnaire - Status version (DTSQs) score (8-question) (treatment satisfaction)
timeFrame: From Baseline to 6 months
measure: Change from baseline to Month 6 in Diabetes Self-Management Questionnaire (DSMQ) score (16-question) (patient perception on ability to manage their disease)
timeFrame: From Baseline to 6 months
measure: Change from baseline to Month 6 in Morisky 8-item scale (adherence)
timeFrame: From Baseline to 6 months
Locations:
city: Dundee
country: United Kingdom
facility: Research Site
state: Angus
city: Cardiff
country: United Kingdom
facility: Research Site
state: Cardiff [Caerdydd GB-CRD]
city: Muirhead
country: United Kingdom
facility: Research Site
state: Dundee City
city: Flintshire
country: United Kingdom
facility: Research Site
state: Flintshire [Sir y Fflint GB-FF
city: London
country: United Kingdom
facility: Research Site
state: Harrow
city: Manchester
country: United Kingdom
facility: Research Site
state: Lancashire
city: Oldham
country: United Kingdom
facility: Research Site
state: Manchester
city: Bonnyrigg
country: United Kingdom
facility: Research Site
state: Midlothian
city: Edinburgh
country: United Kingdom
facility: Research Site
state: Midlothian
city: Fife
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Mid Glamorgan
country: United Kingdom
facility: Research Site
city: Stockport
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Barts and the London, Queen Mary School of Medicine and Dentistry
name: Manesh Saxena
role: PRINCIPAL_INVESTIGATOR
affiliation: Penine Acute Hospitals Trust
name: Deepak Bhatnagar
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiff and Vale NHS Trust - University Hospital of Wales
name: Aled Roberts
role: PRINCIPAL_INVESTIGATOR
affiliation: Leicester General Hospital
name: Melanie Davies
role: PRINCIPAL_INVESTIGATOR
affiliation: Barlow Medical Centre
name: See Kwok
role: PRINCIPAL_INVESTIGATOR
affiliation: Bridge House Medical Centre
name: Keith Richardson
role: PRINCIPAL_INVESTIGATOR
affiliation: Ninewells Hospital and Medical School
name: Deborah Wake
role: PRINCIPAL_INVESTIGATOR
affiliation: Muirhead Medical Centre
name: Ruth Leese
role: PRINCIPAL_INVESTIGATOR
affiliation: Marches Medical Practice
name: Neela Chatakondu
role: PRINCIPAL_INVESTIGATOR
affiliation: Ashgrove Surgery
name: Tom Hoyland
role: PRINCIPAL_INVESTIGATOR
affiliation: Auchtermuchty Health Centre
name: Allan Copland
role: PRINCIPAL_INVESTIGATOR
affiliation: Loanhead Medical Practice
name: Calum MacKenzie
role: PRINCIPAL_INVESTIGATOR
affiliation: Quarryfoot Medical Practice
name: Simon Barrett
role: PRINCIPAL_INVESTIGATOR
affiliation: Llanderyn Health Centre
name: John Shewring
role: PRINCIPAL_INVESTIGATOR
References: