Effect of Tight Glycemic Control on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial
Primary result · Mean C-peptide AUCResult — go to the resultTreatment group difference −0.01 95% CI −0.11 to 0.10Authors' conclusion
In youths with newly diagnosed type 1 diabetes, intensive diabetes management, which included automated insulin delivery, achieved excellent glucose control but did not affect the decline in pancreatic C-peptide secretion at 52 weeks.
Study context
- Population
- Youths aged 7 to 17 years with newly diagnosed T1D; mean (SD) age 11.8 (2.8) years; 43% female; mean (SD) 24 (5) days from diagnosis to randomization108 completed
- Participants
- 113 participants
- Comparison
- Intensive diabetes management incl. AID vs standard care incl. CGM
- Intensive managementn = 61
- Standard caren = 52reference
- Primary endpoint
- Mixed-meal tolerance test-stimulated C-peptide AUC (pancreatic beta cell function)
- Follow-up
- 52 weeks from diagnosis
Methodological detailsdouble-blind, factorial, multicentre (6 US centers), Randomizations July 20, 2020, to October 13, 2021; follow-up completed September 15, 2022, Participants ≥30 kg also assigned to oral verapamil or placebo (factorial design)
- Double-blind
- Factorial
- Multicentre (6 US centers)
- Randomizations July 20, 2020, to October 13, 2021; follow-up completed September 15, 2022
- Participants ≥30 kg also assigned to oral verapamil or placebo (factorial design)
Primary result
Mean C-peptide AUC · 52 weeks
Treatment group difference
−0.01
95% CI −0.11 to 0.10
P = 0.89
By group
Intensive managementvs Standard care
treatment group difference −0.01 (95% CI −0.11 to 0.10); P = 0.89
As reported in the abstract
Further findings
Mean
| Outcome | Intensive management | Standard care | Adjusted difference (95% CI) | |
|---|---|---|---|---|
| Mean CGM time in target range 70 to 180 mg/dL · 52 weeks | 78% | 64% | 16% (10%–22%) | |
| −100102030Difference (linear scale) |
Safety
- Severe hypoglycemia events in each group
- 1
- DKA events in each group
- 1
Original publication
Effect of Tight Glycemic Control on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial. JAMA. Published 28 March 2023. doi:10.
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