Effect of 48 Months of Closed-Loop Insulin Delivery on Residual C-Peptide Secretion and Glycemic Control in Newly Diagnosed Youth With Type 1 Diabetes: A Randomized Trial
Primary result · Fasting C-peptide corrected for fasting glucoseResult — go to the resultMean adjusted difference −2 pmol/L per mmol/L 95% CI −7 to 4Authors' conclusion
Improved glycemic control was sustained over 48 months after diagnosis with CL insulin delivery compared with standard therapy in youth with type 1 diabetes. This did not appear to confer a protective effect on residual C-peptide secretion.
Study context
- Population
- Newly diagnosed youth with T1D aged 10 to 16.9 years, continuing after the 24-month primary phase until 48 months after diagnosisextension phase
- Participants
- 81 participants
- Comparison
- Hybrid closed-loop vs standard insulin therapy
- Closed-loop (CL)n = 47
- Controln = 34reference
- Primary endpoint
- Fasting C-peptide corrected for fasting glucose
- Follow-up
- 48 months
Methodological detailsmulticenter, parallel, intention-to-treat
- Multicenter
- Parallel
- Intention-to-treat
Primary result
As reported in the abstract
Mean adjusted difference
−2 pmol/L per mmol/L
95% CI −7 to 4
P = 0.54
By group
CLvs Control
mean adjusted difference −2 pmol/L per mmol/L (95% CI −7 to 4); P = 0.54
Further findings
| Outcome | Difference (%) (95% CI) | P value | |
|---|---|---|---|
| Central laboratory HbA1c · 48 monthsCLvs ControlLower with CL | 0.9 (0.2–1.5) | P = 0.009 | |
| −1012Difference, % (linear scale) |
| Outcome | Difference (mmol/mol) (95% CI) | P value | |
|---|---|---|---|
| Central laboratory HbA1c · 48 monthsCLvs ControlLower with CL | 10 (3–17) | P = 0.009 | |
| −1001020Difference, mmol/mol (linear scale) |
| Outcome | Difference (percentage points) (95% CI) | P value | |
|---|---|---|---|
| TIR 3.9 to 10.0 mmol/L | 12 (3–20) | P = 0.008 | |
| −100102030Difference, percentage points (linear scale) |
Safety
Events
| Outcome | CL | Control |
|---|---|---|
| Severe hypoglycemic events · extension phase | 6 | 5 |
| DKA events · extension phase | 3 | 4 |
- Severe hypoglycemic events — Total severe hypoglycemic events
- 11
- DKA events — Total DKA events
- 7
Original publication
Effect of 48 Months of Closed-Loop Insulin Delivery on Residual C-Peptide Secretion and Glycemic Control in Newly Diagnosed Youth With Type 1 Diabetes: A Randomized Trial. Diabetes Care. Published 26 June 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →