Abstract Body

Background: Thioredoxin-interacting protein overexpression induces pancreatic beta cell apoptosis and is involved in glucotoxicity-induced beta cell death. Calcium channel blockers, like verapamil, reduce these effects and in a small pilot study in adults with newly diagnosed type 1 diabetes (T1D) was found to preserve pancreatic beta cell function. Near-normalization of glucose levels instituted immediately after T1D diagnosis has been postulated to also preserve beta cell function by reducing glucotoxicity. Previous studies have been hampered by an inability to achieve tight glycemic goals.

Methods: We conducted a double-blind factorial-design trial at six pediatric endocrinology centers across the United States. Using a balanced factorial design, each participant was randomly assigned to the verapamil group or placebo group and also to receive either intensive diabetes management with an automated insulin delivery (AID) system or standard care diabetes management. Eligible participants were 7 to <18 years old with type 1 diabetes diagnosed within 31 days of randomization who had at least one positive islet autoantibody, and for verapamil only weighed ≥30 kilograms and had no contraindication to use of verapamil. The primary outcome for both arms was mixed-meal-tolerance test-stimulated C-peptide area under the curve (AUC) 52 weeks from diagnosis.

Results: For the drug-therapy arm, 88 participants were randomly assigned to the verapamil group (N=47) or placebo group (N=41). Participant age ranged from 8.5 to 17.9 years (mean 12.7±2.4); 74% of the participants identified as non-Hispanic White, 3% as non-Hispanic Black, 17% as Hispanic White, and 5% as another or more than one race or ethnic group. The trial was completed by 44 of the 47 (94%) participants in the verapamil group and 39 of the 41 (95%) in the placebo group.

For the intensive management arm, 113 participants were randomly assigned to the intensive-management (N=61) or standard-care groups (N=52). Participant age ranged from 7.0 to 17.9 years (mean 12±3); 76% of participants identified as being non-Hispanic White, 4% as non-Hispanic Black, 14% as Hispanic White, and 4% as another or more than one race or ethnic group. The trial was completed by 60 of the 61 (98%) participants in the intensive-management group and by 48 of the 52 (92%) in the standard-care group.

Conclusions: We will present the results of change in islet function as assessed by C-peptide AUC at 52 weeks in both arms of this multicenter randomized controlled trial.

Abstract Body

Type 1 diabetes (T1D) is increasingly becoming a “digital disease” for which persons with diabetes (PwD) generate hundreds of continuous glucose monitoring (CGM), insulin dosing, carbohydrate intake, exercise, sleep, and other physiological datapoints per day. These data have value to the PwD themselves in addition to the providers giving medical advice, companies looking to improve algorithms and products, and third-party researchers aiming to better understand T1D care. The desire to share data and grow knowledge is counter-balanced against the need to secure protected health information, prevent breeches in privacy, and obstruct malicious actors. Digital data is generally available to PwD and their providers via manufacturer-based websites and uploaders. These platforms, however, require individual providers to learn and maintain a growing number of accounts, a process which is prohibitive outside specialty diabetes centers. Third-party data aggregators hold the potential to homogenize data sharing and visualization among PwD, providers, and researchers, but move data control outside of the companies creating and improving the devices. In this talk we will discuss data ownership and the pros and cons of data aggregators getting at the question, “Whose Data Is It Anyway?”