Intensive diabetes management does not preserve C-peptide in youths with type 1 diabetes
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Key Takeaways:
- Early near normal glucose levels did not prevent loss of beta-cell function in type 1 diabetes.
- Intensive therapy was associated with better glucose metrics vs. standard care.
Older children with newly diagnosed type 1 diabetes who received intensive diabetes management with automated insulin delivery had no difference in pancreatic C-peptide levels compared with standard care, according to study data.
“Achieving excellent glycemic control soon after diagnosis of type 1 diabetes was unsuccessful in preventing the progressive loss of insulin production by the pancreas as measured by C-peptide levels,” Roy W. Beck, MD, PhD, president and medical director of the Jaeb Center for Health Research Foundation in Tampa, Florida, told Healio. “However, the intervention was highly successful in improving HbA1c levels and glycemic metrics measured with continuous glucose monitoring. This degree of treatment effect, if sustained long term, would be expected to have benefit in reducing the risk of vascular complications.”
Beck and colleagues conducted a randomized, double-blind clinical trial at six pediatric diabetes centers in the U.S. Children and adolescents aged 7 to 17 years diagnosed with type 1 diabetes within 31 days of randomization who had at least one positive islet autoantibody were enrolled. Participants weighing less than 30 kg were randomly assigned 2:1 to intensive diabetes management with automated insulin delivery or standard care. Participants weighing 30 kg or more were randomly assigned in a balanced factorial design to intensive management or standard care and to receive either oral verapamil or placebo. Participants in both the intensive management and standard care groups used CGM. Visits were conducted 6 weeks after randomization and at 13, 26, 39 and 52 weeks from type 1 diabetes diagnosis. Blood samples were collected at randomization and every visit except 6 weeks. The primary outcome was C-peptide area under the curve during a mixed-meal tolerance test at 52 weeks. Secondary outcomes included peak C-peptide level and the proportion of participants with a peak C-peptide of 0.2 pmol/mL or higher.
The findings were published in JAMA.
Intensive management does not affect C-peptide levels
There were 113 youths enrolled in the study (mean age, 11.8 years; 89% white), of whom 61 were randomly assigned to intensive management and 52 to standard care. There were 88 youths who participated in the verapamil portion of the trial. Of those randomly assigned to verapamil, 22 were in the intensive management group and 25 received standard care.
There was no difference in mean C-peptide AUC between the intensive management and standard care groups. The mean peak C-peptide level at 52 weeks and percentage of participants with a C-peptide level of 0.2 pmol/mL or greater were similar between the two groups. No interaction was observed between intensive management and verapamil on C-peptide preservation.
Larger time in range increase with intensive management
The intensive management group had a 0.7% greater decrease in HbA1c from baseline to 52 weeks compared with the standard care group. The percentage of participants achieving an HbA1c of less than 7% at 52 weeks was higher in the intensive management group compared with standard care (71% vs. 54%). Mean time in range of 70 mg/dL to 180 mg/dL at 52 weeks was 78% with intensive management compared with 64% with standard care (P .001). Among those receiving verapamil, mean time in range over 52 weeks was 82% in the intensive management group and 66% in the standard care group, whereas those who received placebo had a mean time in range of 76% with intensive management and 63% with standard care.
There was one report of severe hypoglycemia and one diabetic ketoacidosis event in each group during the trial. Seven device-related adverse events were reported in the intensive management group, with six cases of hyperglycemia due to infusion set failure and one case of skin infection at the infusion site.
Beck noted that prior studies were unable to test the hypothesis that near-normalization of glucose levels could preserve beta-cell function due to limitations with diabetes technology. Though intensive diabetes management did not have a beneficial impact on C-peptide, Beck said, the study showed automated insulin delivery still has a beneficial effect for youths newly diagnosed with type 1 diabetes.
“Use of an automated insulin delivery system started shortly after diagnosis is beneficial in improving glucose levels even though it does not prevent the loss of the pancreas’ ability to produce insulin,” Beck said.
For more information:
Roy Beck, MD, PhD, can be reached at rbeck@jaeb.org.
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