Table 2.
Results of clinical studies evaluating connection-enabled insulin platforms
| Intervention/comparator | Study design/population | Study aim | Method of use | Glycemic/insulin-related outcomes | Patient-reported outcomes |
|---|---|---|---|---|---|
| Connected caps | |||||
| Insulclock® [32] | RCT, open-label, parallel/16 people with T1DM | Clinical impact on glycemic control and treatment compliance and satisfaction with use of device with acoustic and visual plus the Insulclock® app (integrated information on insulin doses, glucose levels, and injection time reminders; active) vs. device with access to dose, time, and duration of injections, without reminders or the Insulclock® app (masked) | Not reported |
Glycemic control improved: TIR increased over time in total study population and active group Glucose SD decreased over time in total study population and masked group Treatment compliance improved: No. of missed and mistimed insulin doses decreased in total study population at end-of-study vs. baseline |
Treatment satisfaction (relating to avoidance hypoglycemia and interference of insulin regimen with work or school) increased in the total study population |
| Insulclock® [28, 29]a | RCT, open-label, crossover/80 people with T2DM | Clinical impact on glycemic control and treatment adherence and satisfaction with use of device with reminders (active) vs. device without feedback (masked) | Not reported |
Glycemic control improved: HbA1c improved vs. baseline in both groups Blood glucose parameters improved vs. baseline (group[s] not specified) Treatment adherence unchanged |
Treatment satisfaction the same with vs. without reminders |
| Insulclock® [36]a | Prospective observational/8 people with T1DM | Impact on duration of insulin injection and treatment satisfaction with use of device with reminder (injection time < 6 s) vs. device without reminder | Not reported | No. of injections < 6 s in duration reduced after vs. before reminder activated | Treatment satisfaction, with self-perceived benefit shown (not specified whether before vs. after reminder or overall) |
| GoCap/Glucose meter [34]a | Prospective, observational/20 people with T1DM or T2DM | Acceptability of device used with connected blood glucose meter to people with diabetes | Insulin dose and SMBG data downloaded for longitudinal tracking | Device easy to use, convenient and useful for diabetes management; allowed access to longitudinal automatically uploaded data by the person with diabetes and HCP | |
| Connected insulin pens | |||||
| NovoPen® 6 [33, 37, 40] | Prospective observational/94 adult people with T1DM | Influence of device on insulin regimen management and glycemic control in people using CGM in a real-world setting; the device was used with injection data overview blinded (could still see CGM data and dose of last injection; baseline) vs. unblinded | Person with diabetes and HCP downloaded, discussed and acted upon pen and CGM findings at each consultation (pen data could not be downloaded outside the HCP’s office) |
Glycemic control improved vs. baseline: TIR increasedb Time in hyperglycemia decreasedb Time in hypoglycemia (glucose < 3 mmol/L) decreasedb Bolus insulin dose increasedb Number of MDB decreasedc |
Not reported |
| Prospective observational/39 children/ adolescents with T1DM | Glycemic parameters following introduction of a connected insulin pen in a pediatric population | Not reported |
Risk of hypoglycemia reduced vs. baseline: Hypoglycemia incidence reduced Time in hypoglycemia reduced TIR unaffected Time in hyperglycemia unaffected Basal insulin dose increased/bolus insulin dose unaffected |
Not reported | |
| InPen® [35]a | Prospective, real-world, observational/482 people with T1DM or T2DM (USA) [conference paper] | Real-world clinical effect of device on key short-term glycemic control in people using CGM | Not reported |
Glycemic control improved vs. before device use: TIR not reduced TBR reduced |
Not reported |
| Bravo® pen [30, 31]a | Prospective, observational/68 people with T1DM or T2DM | Effect on MBD of device with blinded rtCGM vs. unblinded rtCGM | Not reported | Number of MBD reduced with use of rtCGM vs. no use of rtCGM | More likely to have a higher level of confidence in hypoglycemia, less fear of hypoglycemia, increased health problem-solving skills and have a lower illness perception with use of rtCGM vs. baseline |
| Connected insulin platform | |||||
| ESYSTA® [27] | Prospective, observational/215 people with T1DM or T2DM | Impact of device on care of people with poor metabolic control despite specialist support and acceptance of device by people with diabetes and HCPs | Interaction and communication between the people with diabetes and HCP was improved, with simplified documentation; the overview of blood glucose and insulin values was improved for both the person with diabetes and with HCP; self-management was improved |
Glycemic control improved vs. baseline: HbA1c reduced Blood glucose profile improved No increase in hypoglycemic episodes |
Person with diabetes’ and HCP’s views of the device were positive Most people with diabetes and HCPs would recommend the device to others |
CGM continuous glucose monitoring, HbA1c glycated hemoglobin, HCP health care professional, MBD missed bolus dose, T1DM type 1 diabetes mellitus, T2DM type 2 diabetes mellitus, RCT randomized controlled trial, rtCGM real-time CGM, SD standard deviation, SMBG self-monitoring of blood glucose, TBR time below range, TIR time in range
aConference abstract
bData obtained from 14 people with diabetes
cData obtained from 81 people with diabetes