Abstract Body

Today’s Headlines for CGM use in T1D:

“CGM-First,” “CGM-Standard of Care,” “CGM- Most significant advance in diabetes management since the discovery of insulin!”

Today’s Headlines for CGM use in T2D non-insulin users:

Amer. Board Internal Med- Choosing Wisely campaign promotes clinician-patient conversations about avoiding unnecessary care … like this example, “Don’t routinely recommend daily home glucose monitoring for patients who have Type 2 diabetes and are not using insulin.”

What is the nature of the data we have today on CGM use in T2D non-insulin users?

Intriguing - survey data; “they say it helps…

Interesting - pilot data; "I think" it might help…

Innovative - technology programs; CGM "seems to" help patients…

Incomplete - registry data, hints at populations of PwD who do better, so "maybe it does" help...

Informative - trials using CGM in T2D patients on insulin resulted in glycemic improvement

compared to using SMBG, but minimal insulin dose changes were made, with

the concluding summary, “It must have been CGM guided lIfestlye changes.”

Insistent - powerful anecdotes, and voices of people with diabetes not on insulin, saying “FOR SURE IT HELPS!” “Please - Listen to me.”

What do we need to do for CGM to become a standard of care in T2D non-insulin users?

Determine - how A1C and CGM data align/coexist in the management of diabetes

Define - the outcome(s) we are trying to achieve with the help of CGM

Decide - if CGM data and profiles can facilitate healthy lifestyle choices

Deliberate - on the role of CGM in helping the selection of high value diabetes drugs

Decipher - CGM user registry data by separating out and evaluating T2D non-insulin users

Design - RCT’s and robust real-word evaluations to demonstrate the value of CMG in

non-insulin users

My prediction is that after we Investigate and Discuss the “I_s” and “D_s” above we will want to rewrite a headline for people with T2D not using insulin that reads something like: “Of Course CGM Should Be Part of Diabetes Education, Management and Support for All People Living with Diabetes.”

Background and Aims

The InRange study demonstrated non-inferiority of insulin glargine 300 U/mL (Gla-300) to insulin degludec 100 U/mL (IDeg-100) in people with T1D using continuous glucose monitoring (CGM) metrics. In this subanalysis, the results for the tertiary CGM endpoints are presented.

Methods

InRange (NCT04075513) was a multicenter, randomized, active-controlled, parallel-group, 12-week, open-label trial comparing Gla-300 vs IDeg-100 in adults with T1D using 20-day CGM profiles (≥10 days evaluable). Here we present descriptive, exploratory data for CGM metrics including mean glucose, Glucose Management Indicator (GMI), and time spent above, within and below glucose ranges, at Week 12.

Results

Overall, 343 participants (Gla-300, n=172; IDeg, n=171) were randomized with mean (±SD) age 42.8±13.3 years. HbA_1c (%) at Week 12 was 7.5±0.8 for Gla-300 and 7.4±0.8 for IDeg-100. Mean number of days of evaluable CGM data at Week 12 was 16 for both treatment groups. Mean (±SD) percent TIR 70–180 mg/dL for Gla-300 and IDeg-100 was 51.9±13.8 and 55.4±13.7, respectively. Percent TAR >180 mg/dL and TBR (<70 and <54 mg/dL; anytime and nocturnal) were comparable between the two groups. At Week 12, the mean glucose and GMI were comparable between Gla-300 and IDeg-100 groups (Table). CGM-derived hypoglycemia rates were 3–5-fold (anytime) and 5–6-fold (nocturnal) higher than SMPG-derived rates during the CGM data collection period (Weeks 10–12).

Conclusions

The InRange study shows that after 12 weeks of treatment with Gla-300 or IDeg-100, comparable CGM-derived outcomes are observed in people with T1D.