None listed
Conditions
Brief summary
The main purpose of this research is to evaluate the feasibility of a two-week education module designed to inform individuals living with type 1 diabetes how to assess device generated data. This education module has been created by endocrinologists, diabetes educators, industry, dieticians, psychologists, community engagement and education specialists. The researchers will also evaluate participant’s satisfaction with the module and satisfaction in the management of their diabetes, as well as looking at their blood glucose control after the education module. Involvement will last around 26-28 weeks and will involve 7 visits, and at least 4 of these visits will occur at the clinical trial site. Participants will be asked to wear a continuous glucose monitor, and a keep a study diary at specified times over the course of the trial.
Interventions
The education intervention, ‘The Making Sense Program’ was designed based on and in the light of ongoing input by people living with diabetes and an expert reference group consisting of endocrinologists, diabetes educators, industry, dieticians, psychologists, community engagement and education specialists. The education intervention will be conducted over a period of two weeks. Participants will attend in groups of approximately eight. It will be implemented as a combination of teleconferencing, on-line, and face-to face sessions. The time required to implement each stage of the education intervention will be recorded. A facilitator training day will be delivered by a registered nurse-credentialled diabetes educator and Diabetes Victoria, and will occur 1-2 weeks prior to the introductory group session. The facilitator training day will provide orientation to the program and will cover the objectives of the education modules. There are three stages to the education intervention, detailed below. Once completing stage 1, participants will immediately move to stage 2. Stage 3 will commence two weeks after stage 2. Attendance to stage 1 and 3 will be recorded, and completion of stage 2 will be monitored through registration via the online platform. Stage 1: All participants have had a 90-minute introductory group session where they will be provided with an overview of the program. The virtual group session will be facilitated by a peer (a person living with type 1 diabetes (T1D) experienced in the use of technology who has undertaken the facilitator training day). The peer facilitator is supported by a registered nurse-credentialled diabetes educator (RN-CDE) who has also participated in the facilitator training day. During this session participants will meet one another and have an opportunity to identify their expectations for the program. They will also be provided with instructions on how to move through the program including the on-line education modules. Stage 2: The three training modules are hosted on a web-based platform. (EdApp [edapp.com]) which provides flexibility and may be completed at the person’s convenience. The platform can be accessed from a desktop or laptop computer, smartphone, or tablet. People may leave a module and return to it later. The training modules are: (i) Making the most of glucose monitoring technology (CGM and Flash): An Introduction (ii) Making the most of glucose monitoring technology (CGM and Flash): Interpreting your Data (iii) Making the most of glucose monitoring technology (CGM and Flash): An Introduction to Insulin Pumps and Hybrid Closed Loop Systems Modules 1 and 3 may be optional as determined by the study team. Module 1 provides basic information that the experienced device user may be already familiar with. Module 2 provides core information and is to be completed by all participants. Module 3 can only be attempted after completing Module 2 and will not be applicable to those participants using multiple daily injections (MDI). Each module comprises a series of lessons and a ‘Briefcase’ feature with supporting material. The ‘Briefcase’ has been specifically designed for this study. The lessons within each module are to be completed sequentially. Apart from the first lesson, each subsequent lesson can only be attempted after an earlier lesson is completed. Each lesson starts with a title page and then a dot point summary of the information to be covered by the lesson. There are videos embedded within each lesson expanding on specific points. There are also quiz questions during each lesson whose sole purpose is to reinforce important study points and they will not be used to determine a “pass” or “fail”. At the end of each quiz question, the person will be provided with a “correct” or a “not quite” message and reinforcing information will then be provided. Upon completion, a lesson can be repeated, or the person can go on to the next lesson in the module. The ’Briefcase’ feature contains a list of resources relevant to the module. These may take the form of written pdf documents, links to on-line resources, or further activities Stage 3: It is anticipated that participants will complete the on-line module(s) within two weeks. After this time, they will attend a 4-hour group session (virtual or face-to-face). The group session will be facilitated by the same peer who led the introductory session, and they will be supported by the same RN-CDE. During the final group session, participants will have an opportunity to consolidate their online learning and to practice their new skills in interpreting data from their glucose sensing device. They will be encouraged to provide examples of their own CGM data though this will not be mandatory.
Sponsors
Study design
Eligibility
Inclusion criteria
T1D (diagnosis consistent with American Diabetes Association Classification of Diabetes Mellitus); Age >18Y; HbA1c <9.5%; Fluent in English; using carbohydrate counting; >3 months On MDI or insulin pump therapy (IPT) and safely operating a real time-continuous glucose monitor (RT-CGM) or intermittent scanning glucose monitor (ISGM) device; Willing and able to download and review device data; Living in an area with internet and cellular phone coverage; English speaking. Recruitment will be stratified approximately 1:1 MDI and IPT and at least 40% of all participants will be on either RT-CGM or ISGM. At least 10 days of CGM data between screening and the baseline visit.
Exclusion criteria
Pregnant or planning pregnancy; Using open-source artificial pancreas system (so-called ‘do-it-yourself’ (DIY) technology); Use of any non-insulin glucose-lowering agent within the past 3 months; Oral or injected steroid use within the past 3 months; active significant nondiabetic illness impacting glucose management (e.g. coeliac disease, thyroid disease, myocardial ischaemia) or any severe or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the ability to meet protocol requirements.