A New Wizard for Insulin Sensitivity Estimation From SAP: a Randomized Controlled Trial in Adolescents With T1D
Withdrawn before enrolling · Not applicable
Conditions studied: Diabetes Mellitus
In brief
We aim to test the efficacy of a new method for determining individual insulin sensitivity (IS) based on sensor-augmented-insulin pump (SAP) data in order to customize the insulin to carbohydrate ratio (CR) in adolescents with type 1 diabetes (T1D). To date, the individual insulin sensitivity (IS) could only be investigated by intensive and invasive research techniques that are not feasible to perform in an outpatient setting for pediatric patients with diabetes. Recently published studies have demonstrated the efficacy of an algorithm to calculate the patient specific insulin sensitivity to customize the CR for adult patients with T1D. The algorithm has been validated in adult patients, however not yet investigated in the pediatric population with T1D. The aims of our study are: 1. to customize the CR of pediatric subjects with T1D using the individualized insulin sensitivity index (ISind) to improve post-prandial blood glucose control after a standard meal. 2. to test, under free living condition (at home), the efficacy of the customized CR in improving post-prandial glycemic control for pediatric subjects with T1D. This approach would have at least two potential benefits for pediatric patients with T1D: 1. To provide a non-invasive tool for individualizing their home insulin therapy; 2. To offer a reliable instrument for adjusting the meal bolus of the current hybrid closed loop (HCL) systems to account for the inter-subject variability in insulin action.
Key facts
- Study ID
- NCT03034759
- Run by
- Yale University
- People needed
- 0
- Starts
- 2019-10-01
- Expected to finish
- 2022-12-01
- Last updated by the study team
- 2019-07-11
Who can join
Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 12-21 year old.
- Clinical diagnosis of T1D ≥1 year
- Treatment with sensor augmented pump therapy (insulin pump + glucose sensor) for at least 1 month
- HbA1c <10%
- Be able to comprehend written and spoken English
You may not qualify if…
- Pregnancy, breast feeding, or plans to get pregnant for the next 12 months
- On medications that affect insulin sensitivity; has other medical conditions known to affect insulin sensitivity;
- Cognitive impairment
Where it is running
- Yale Pediatric Diabetes Research Program — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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