Single arm study assessing the effect on glycaemic control from baseline to week 24 as measured by HbA1c, with initiation of real-time continuous glucose monitoring (CGM) in a primary care setting, in individuals with type 2 diabetes mellitus (T2DM) on insulin therapy with a baseline HbA1c ≥64 mmol/mol (≥8.0%). Study will include exploratory analysis to assess the effect of CGM compared to standard of care (SoC). Analysis will involve, but not limited to, healthcare resource use, laboratory data
Type 2 Diabetes Mellitus
The study has two cohorts: One will be a single arm with 24 week duration and the other with be a matched arm collecting retrospective data. Cohort 1: Single Arm (24 Week duration) Participants will complete the following visits: - Screening: At this visit, participants will be consented, complete screening procedures and assessment, and begin wearing the blinded CGM for around 10 days. This means they will wear the study device but will not be able to see any values. - Baseline - Day 0: At this visit, the participant will return their blinded CGM and start using the Real Time (RT)-CGM. They will receive enough sensors to last until their next visit. - Follow-up -Day 28/ Week 4: At this time point, the investigator will review the participants RT-CGM, and if the participants values are trending well, the investigator will mark the visit complete and participant will not be contacted. If the RT-CGM values require action (eg. change in medications, etc), the investigator will call or schedule the participant for a visit. This mean the participant will be contacted. -Follow-up - Day 84/ Week 12: The participant will return to the study centre and download the data from the RT-CGM, complete questionnaires, and labs. Sponsor may reach sites to schedule a meet with the participant to conduct interview or complete in person. - Final - Day 168/ Week 24: The participant will return to the study centre and download the data from the RT-CGM, complete questionnaires, and labs. Sponsor may reach sites to schedule a meet with the participant to conduct interview or complete in person. Cohort 2: Matched Arm Enrollment in Cohort 1 will be complete and all participants will complete all visits before enrolling into cohort 2. Participants will complete the following visits: - Screening: At this visit the participant will be consented, and begin eligibility criteria. The participant is consenting to have their data retrospectively reviewed and retrieved at the
1. Age at least 18 years. 2. Clinical diagnosis of Type 2 diabetes on insulin for a minimum of 3 months duration confirmed via medical records/source documentation by a qualified individual to make a medical diagnosis. 3. Diabetes care predominately managed in primary care. Note: Secondary care diabetes management will not be exclusionary if the majority of diabetes care is managed in the primary care setting. 4. HbA1c ≥64 mmol/mol (≥8.0%) Note: By local lab at screening or within 28 days of screening by local lab or POC. Additionally, cohort 2 participants must have at minimum, two HbA1c lab results available. 5. Stable diabetes, cardio-metabolic (e.g., lipid lowering and hypertensive medications) and anti-obesity medication regimen (medication classes) and dose (equivalent dose if diabetes/cardio-metabolic/anti-obesity- specific medication has been changed within same medication class) for 3 months prior to enrolment. Note: Changes ≤ 10% in total daily doses of insulin in the 3 months prior to screening are considered stable. 6. Participant capable of becoming pregnant must have a negative urine pregnancy test at time of screening and do not plan pregnancy. Note: Participants are classified as non-childbearing potential due to menopause (with at least one year since last menses), a medical condition or medical surgery confirmed by the investigator. 7. Investigator believes that the participant has the cognitive capacity to provide informed consent Cohort 1 Only: 8. Can successfully and safely use CGM and is capable and willing to follow study procedures. Note: This includes considering the potential impact of medical conditions known to be present including cardiovascular, liver, kidney disease, thyroid disease, adrenal disease, malignancies, vision difficulties, active proliferative retinopathy, skin or skin allergy condition, Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infections; haemophilia; and other medical conditions; psychiat
1. Diagnosis of type 1 diabetes. 2. Any surgical procedure for weight loss within the year prior to enrolment or plans for undergoing such bariatric surgery during the study. 3. Concomitant disease or condition that in the opinion of the investigator may compromise participant safety, including but not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits. 4. Use of medications known to exacerbate hyperglycaemia (current or for more than 14 days in the past 3 months), corticosteroids (oral and injectable) or certain psychotropics (antipsychotics, e.g., clozapine, olanzapine, risperidone, and quetiapine). 5. Breastfeeding. 6. Anticipated acute uses of glucocorticoids (oral, injectable, or IV), that will affect glycaemic control and impact HbA1c. 7. Presence of a haemoglobinopathy or other condition that is expected to affect the measurement of HbA1c in the judgment of the investigator. 8. The participant, immediate family member(s), and/or person(s) living within the household work for Dexcom, Medtronic, Ypsomed, SiBionics, Glysens Inc., Abbott Laboratories, Roche, Senseonics, Waveform, Ascensia Diabetes Care, Yuwell, i-SENS, Bionime, POCTech, or Insulet and any other diabetes company; immediate relation to study staff. 9. Current participation in another interventional study protocol or prior participation in an interventional study protocol in which the participant received active drug within the 90 days prior to screening. Note: Participants will not be excluded if enrolled in another observational trial, wherein the participant is in the follow-up phase and no tests/procedures impacting the participant’s health are required. Participants participating in studies using only approved medications (that are not specifically excluded) or devices may qualify for this study. 10. Use of personal real-time or intermittent s