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Effect of Tight Glycemic Control on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A
Jennifer McVean1,2, Gregory P Forlenza3, Roy W Beck4
1University of Minnesota, Minneapolis.
Importance:
Near normalization of glucose levels instituted immediately after diagnosis of type 1 diabetes has been postulated to preserve pancreatic beta cell function by reducing glucotoxicity. Previous studies have been hampered by an inability to achieve tight glycemic goals.
Objective:
To determine the effectiveness of intensive diabetes management to achieve near normalization of glucose levels on preservation of pancreatic beta cell function in youth with newly diagnosed type 1 diabetes.
Design, Setting, And Participants:
This randomized, double-blind, clinical trial was conducted at 6 centers in the US (randomizations from July 20, 2020, to October 13, 2021; follow-up completed September 15, 2022) and included youths with newly diagnosed type 1 diabetes aged 7 to 17 years.
Interventions:
Random assignment to intensive diabetes management, which included use of an automated insulin delivery system (n = 61), or standard care, which included use of a continuous glucose monitor (n = 52), as part of a factorial design in which participants weighing 30 kg or more also were assigned to receive either oral verapamil or placebo.
Main Outcomes And Measures:
The primary outcome was mixed-meal tolerance test-stimulated C-peptide area under the curve (a measure of pancreatic beta cell function) 52 weeks from diagnosis.
Results:
Among 113 participants (mean [SD] age, 11.8 [2.8] years; 49 females [43%]; mean [SD] time from diagnosis to randomization, 24 [5] days), 108 (96%) completed the trial. The mean C-peptide area under the curve decreased from 0.57 pmol/mL at baseline to 0.45 pmol/mL at 52 weeks in the intensive management group, and from 0.60 to 0.50 pmol/mL in the standard care group (treatment group difference, -0.01 [95% CI, -0.11 to 0.10]; P = .89). The mean time in the target range of 70 to 180 mg/dL, measured with continuous glucose monitoring, at 52 weeks was 78% in the intensive management group vs 64% in the standard care group (adjusted difference, 16% [95% CI, 10% to 22%]). One severe hypoglycemia event and 1 diabetic ketoacidosis event occurred in each group.
Conclusions And Relevance:
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.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04233034.
Insights
Intensive diabetes management using automated insulin delivery in youth with new type 1 diabetes improved glucose control but did not preserve pancreatic beta cell function. This finding highlights the need for further research into preserving beta cell function in type 1 diabetes.
Area of Science:
- Endocrinology
- Metabolic Diseases
- Pediatric Diabetes Research
Background:
- Type 1 diabetes (T1D) management aims to prevent glucotoxicity and preserve pancreatic beta cell function.
- Previous studies faced challenges in achieving tight glycemic control for beta cell preservation.
- Near normalization of glucose levels is a potential strategy to reduce glucotoxicity in newly diagnosed T1D.
Purpose of the Study:
- To evaluate the effectiveness of intensive diabetes management in preserving pancreatic beta cell function in youth with newly diagnosed T1D.
- To determine if automated insulin delivery systems can achieve near normalization of glucose levels and impact beta cell function.
- To assess the long-term effects of intensive glycemic control on C-peptide secretion in pediatric T1D.
Main Methods:
- A randomized, double-blind clinical trial involving 113 youth (aged 7-17 years) with newly diagnosed T1D.
- Participants were assigned to either intensive diabetes management with an automated insulin delivery system or standard care with a continuous glucose monitor.
- The primary outcome measured was the change in C-peptide area under the curve (AUC) via a mixed-meal tolerance test at 52 weeks.
Main Results:
- Intensive management group achieved higher time in range (78%) compared to standard care (64%) at 52 weeks.
- No significant difference was observed in the decline of C-peptide AUC between the intensive management and standard care groups (P=.89).
- Both groups experienced similar rates of severe hypoglycemia and diabetic ketoacidosis.
Conclusions:
- Intensive diabetes management, including automated insulin delivery, effectively improves glycemic control in youth with newly diagnosed T1D.
- This intensive approach did not demonstrate a significant benefit in preserving pancreatic beta cell function (C-peptide secretion) at 52 weeks.
- Further strategies are needed to protect beta cell function beyond achieving excellent glucose control in pediatric T1D.
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