Safety and Feasibility of Algorithmic Continuous Glucose Monitoring-Based Titration in People with Type 2 Diabetes Using Insulin Degludec, With or Without Noninsulin Glucose-Lowering Drugs: A 16-Week Randomized Controlled Trial
Authors' conclusion
Using CGM and receiving algorithmic CGM-based titrations were feasible, safe, and had favorable overall glycemic metrics.
Study context
- Population
- Adults with T2D (HbA1c 7%-9%) using degludec and adjunctive noninsulin agents, without rapid-acting insulinrandomized
- Participants
- 30 adults
- Comparison
- Weekly algorithmic continuous glucose monitoring (CGM)-based titration with open CGM vs weekly self-monitoring blood glucose (SMBG)-based titration with blinded CGM
- Primary endpoint
- Change in CGM-measured time in range (TIR) (70-180 mg/dL), tested for noninferiority (−5%-pt margin)
- Follow-up
- Baseline to week 16
Methodological detailstwo-site, noninferiority, 2:1 allocation, 16-week
- Two-site
- Noninferiority
- 2:1 allocation
- 16-week
Primary result
As reported in the abstract
Change in TIR
Estimated treatment difference
+14.6 %-pt
one-sided 95% CI lower bound +4.0P < 0.005
exceeding the noninferiority margin
Estimated treatment difference
+14.6 %-pt
two-sided 95% CI 1.3–27.8P = 0.03
exploratory superiority analysis
EXP
+20.3
mean · %-pt
CTR
+8.3
mean · %-pt
Further findings
TIR at baseline
TIR at week 16
Safety
Level 2 hypoglycemia episodes (SMBG <54 mg/dL)
Median
| Outcome | EXP | CTR |
|---|---|---|
| CGM-measured hypoglycemia (<70 mg/dL) | 0.34% (IQR 0.09–0.90) | 0.00% (IQR 0.00–0.41) |
Severe hypoglycemia and serious adverse events
- No severe hypoglycemia or serious adverse events occurred
Original publication
Safety and Feasibility of Algorithmic Continuous Glucose Monitoring-Based Titration in People with Type 2 Diabetes Using Insulin Degludec, With or Without Noninsulin Glucose-Lowering Drugs: A 16-Week Randomized Controlled Trial. Diabetes Technol Ther. Published 6 February 2026. doi:10.
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