A 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 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

Study Overview

• Status: Terminated
• Conditions: Type II Diabetes Mellitus
• Intervention / Treatment: Other: Use of digital disease management tool in participants with T2DM

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 Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• United Kingdom
  • Fife, United Kingdom
    • Research Site
  • Leicester, United Kingdom
    • Research Site
  • London, United Kingdom
    • Research Site
  • Mid Glamorgan, United Kingdom
    • Research Site
  • Stockport, United Kingdom
    • Research Site
  • Angus
    • Dundee, Angus, United Kingdom
      • Research Site
  • Cardiff [Caerdydd GB-CRD]
    • Cardiff, Cardiff [Caerdydd GB-CRD], United Kingdom
      • Research Site
  • Dundee City
    • Muirhead, Dundee City, United Kingdom
      • Research Site
  • Flintshire [Sir y Fflint GB-FF
    • Flintshire, Flintshire [Sir y Fflint GB-FF, United Kingdom
      • Research Site
  • Harrow
    • London, Harrow, United Kingdom
      • Research Site
  • Lancashire
    • Manchester, Lancashire, United Kingdom
      • Research Site
  • Manchester
    • Oldham, Manchester, United Kingdom
      • Research Site
  • Midlothian
    • Bonnyrigg, Midlothian, United Kingdom
      • Research Site
    • Edinburgh, Midlothian, United Kingdom
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with a prior diagnosis of Type II Diabetes Mellitus.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Use of digital disease management tool in participants with T2DM; 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.
Standard of Care cohort; Participants will have standard care with no access to the digital disease management tool.	Other: Use of digital disease management tool in participants with T2DM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who achieve HbA1c levels <7% at Month 6	Proportion of participants who achieve HbA1c levels <7% at Month 6	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.	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.	From Baseline to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of times smart phone- and/or web portal-based tool accessed per patient	Number of times smart phone- and/or web portal-based tool accessed per patient. Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.	From Baseline to 6 months
Mean percent change from baseline to Month 6 in SBP	Mean percent change from baseline to Month 6 in SBP. Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.	From Baseline to 6 months
Proportion of patients who achieve BP <140/90 mmHg at Month 6	Proportion of patients who achieve BP <140/90 mmHg at Month 6. Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.	From Baseline to 6 months
Mean percent change from baseline to Month 6 in LDL-C	Mean percent change from baseline to Month 6 in LDL-C. Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.	From Baseline to 6 months
Proportion of patients who achieve LDL-C <100 mg/dL at Month 6	Proportion of patients who achieve LDL-C <100 mg/dL at Month 6. Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.	From Baseline to 6 months
Length of time from first to last usage of smart phone- and/or web portal-based tool	Length of time from first to last usage of smart phone- and/or web portal-based tool. Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.	From Baseline to 6 months
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)	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). Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.	From Baseline to 6 months
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)	Mean difference in Emergency Room visits between active and control group during the 6-month study period as reported by patients at the end of the study (to examine potential differences in resource utilization). Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.	From Baseline to 6 months
Change from baseline to Month 6 in Diabetes Treatment Satisfaction Questionnaire - Status version (DTSQs) score (8-question) (treatment satisfaction)	Change from baseline to Month 6 in Diabetes Treatment Satisfaction Questionnaire - Status version (DTSQs) score (8-question) (treatment satisfaction). The Patient-reported outcomes (PROs) include DTSQs. The DTSQs (8-item scale) is a widely used instrument in diabetes in both clinical trials and routine clinical practice, to measure of treatment satisfaction.	From Baseline to 6 months
Change from baseline to Month 6 in Diabetes Self-Management Questionnaire (DSMQ) score (16-question) (patient perception on ability to manage their disease)	Change from baseline to Month 6 in Diabetes Self-Management Questionnaire (DSMQ) score (16-question) (patient perception on ability to manage their disease). The PROs include the DSMQ. The DSMQ is a 16-item questionnaire to assess self-care activities associated with glycaemic control in patients with diabetes. Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.	From Baseline to 6 months
Change from baseline to Month 6 in Morisky 8-item scale (adherence)	Change from baseline to Month 6 in Morisky 8-item scale (adherence). The PROs include the Morisky Scale. The Morisky Scale is an 8-item medication adherence questionnaire. Mean change from baseline to intermediate visits are optional and only occur if it is a part of standard of care.	From Baseline to 6 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel
• Investigators: Principal Investigator: Manesh Saxena, Barts and the London, Queen Mary School of Medicine and Dentistry; Principal Investigator: Deepak Bhatnagar, Penine Acute Hospitals Trust; Principal Investigator: Aled Roberts, Cardiff and Vale NHS Trust - University Hospital of Wales; Principal Investigator: Melanie Davies, Leicester General Hospital; Principal Investigator: See Kwok, Barlow Medical Centre; Principal Investigator: Keith Richardson, Bridge House Medical Centre; Principal Investigator: Deborah Wake, Ninewells Hospital and Medical School; Principal Investigator: Ruth Leese, Muirhead Medical Centre; Principal Investigator: Neela Chatakondu, Marches Medical Practice; Principal Investigator: Tom Hoyland, Ashgrove Surgery; Principal Investigator: Allan Copland, Auchtermuchty Health Centre; Principal Investigator: Calum MacKenzie, Loanhead Medical Practice; Principal Investigator: Simon Barrett, Quarryfoot Medical Practice; Principal Investigator: John Shewring, Llanderyn Health Centre

Publications and helpful links

Helpful Links

• D1841C00002 Synopsis

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2016
• Primary Completion (ACTUAL): October 13, 2016
• Study Completion (ACTUAL): October 13, 2016

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 20, 2016
• First Posted (ESTIMATE): April 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 13, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: HbA1c; Standard care; Digital disease management tool; Type 2 diabetes mellitus/ T2DM; PRO questionnaires; Smart phone/ personal computer with internet access
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: D1841C00002