Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine
Conditions
Interventions
Randomised study with two arms. Randomisation using online tool.
Arm 1: On-going standard care with InPenTM Insulin pen with SimpleraTM CGM (without using Smart Bolus advisor)
Arm 2: The InPenTM Smar
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is age =18 years old at time of screening 2. Clinical diagnosis of type 2 diabetes [ use of insulin >2 years after diagnosis] 3. > 90 days on a basal bolus regimen with >2 bolus doses a day 4. Subject has a glycosylated haemoglobin (HbA1c) =8.0% (64 mmol/mol) at time of screening visit (in last 3 months) 5. Using stable doses of GLP-1 and/or SGLT2i (For past 3 months) 6. The subject is willing to use the study CGM and connect data via the cloud 7. Subject is willing and able to sign and date informed consent, comply with all study procedures, and use study devices, as required during the study 8. Subject is on Humalog , Novolog, Novorapid, Lyumjev or Fiasp 9. Subject is willing to use Humalog/Novolog/Novorapid/Fiasp/Lyumjev if using any other brand of quick acting insulin
Exclusion criteria
Exclusion criteria: 1. Subject has had CKD stage 4 or more defined by creatinine clearance <30 ml/min, as assessed by local lab test = 6 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft or MDRD equations or receiving dialysis. 2. Subject has a history of hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices, per investigator judgment. 3. Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection). 4. The subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study. 5. The subject is legally incompetent, illiterate, or vulnerable person. 6. Any diagnosis of diabetes other than type 2 diabetes including those secondary to chronic disease. 7. In the investigator’s opinion, intensification of glucose therapy is not suitable for the participant, such as other comorbidities or frailty. 8. Participant is currently on a mixed therapy combination with basal insulin (i.e., basal insulin with any other glucose-lowering therapy administered as a combined medication), e.g., Xultophy. 9. In the investigator’s opinion the participant has any other concomitant disease or condition that may compromise patient safety and/or interfere with the normal conduct of the study and/or interpretation of the study results, including and not limited to; unstable coronary heart disease, learning disabilities, severe mental illness (such as psychotic disorder, bipolar disorder, dementia, substance and/or alcohol dependence, depression with active suicidal ideation), a known or suspected eating disorder, or any other uncontrolled medical condition. 10. Currently prescribed or anticipated short term use of glucocorticoid therapy (oral, intra-articular, intramuscular, or intravenous) for any acute condition. 11. Known (or suspected) allergy to medical grade adhesives at enrolment. 12. Currently participating in another study that could affect glucose measurements or glucose management. 13. Has a planned major medical intervention expected to significantly alter red cell lifespan such as, chemotherapy, major surgery requiring blood transfusion or has a history of blood transfusion in the last three months. 14. A female participant who is pregnant, planning to become pregnant within the next 6months or becomes pregnant/ breastfeeding during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in HbA1c is measured using blood tests at baseline, 12 weeks, and 24 weeks 2. HbA1c levels are measured using blood tests at 12 weeks and 24 weeks 3. Adjusted mean difference in HbA1c between groups is measured using linear regression analysis at 12 weeks and 24 weeks 4. Confidence intervals for HbA1c levels are measured using statistical analysis at 12 weeks and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in % Time spent in range with sensor glucose (SG) between 70-180 mg/dL (3.9-10.0 mmol/L) over 12 weeks of the study phase. Interpretation of CGM data at 12 weeks 2. Difference in % Time spent in hyperglycaemic range with SG > 180 mg/dL (> 10.0 mmol/L) over 12 weeks of the study phase. Interpretation of CGM data at 12 weeks 3. Difference in % Time spent in hypoglycaemic range with SG < 70mg/dL (< 4.0mmol/l) and <54mg/dL (< 3mmol/l) over 12 weeks of the study phase. Interpretation of CGM data at 12 weeks 4. Number of biochemical hypoglycaemic events< 54 mg/dL (3.0 mmol/L), defined as sensor values < 54 mg/dL (3.0 mmol/L) per 15 consecutive minutes. Interpretation of CGM data at 12 weeks 5. Change between run-in phase and study phase in TIR (3.9-10.0 mmol/l) and TBR (< 3.9 mmol/l) in the control group vs the intervention group. Interpretation of CGM data at 12 week 6. Difference in glucose variability (CoV and SD). Interpretation of CGM data at 12 week 7. Change in total daily dose of insulin from baseline to end of study. Review of insulin dose and CGM data at 12 and 28 weeks 8. Change in other diabetes related medication usage from baseline to end of study. Review of medication at 12 weeks 9. Change in scores from the Type 2 diabetes distress assessment system (T2-DDAS), the DAWN2 Impact of Diabetes Profile (DIDP), System Usability Scale (SUS) and EQ 5d 5L questionnaire. By using respective questionnaires at 0, 12 and 24 weeks 10. Change in Hypoglycaemia Confidence Scale, Clarke and Gold scores. By using respective questionnaires at 0, 12 and 24 weeks 11. Change in Time in ranges from week 12 to week 24 in the control arm. Interpretation of CGM data at 12 and 24 weeks 12. Difference in missed boluses and number of boluses per day. Interpretation of CGM data at 12 and 24 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactPratik Choudhary
Outcome results
None listed