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Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes

NCT04259775 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-04-27

No results posted yet for this study

Summary

We propose conducting a pilot randomized study to assess the feasibility of using the automated insulin dose adjustment (AIDA) system to assist the parents of children with Type 1 Diabetes to make insulin dose adjustments between visits with their diabetes provider. Study results will be used to inform a larger RCT with an anticipated primary outcome of change in HbA1c in patients managed with either standard care (changes in therapy settings effected at regularly scheduled patients visits) or AIDA guided care.

Conditions

Interventions

DEVICE

Automated Insulin Dose Adjustment

The system originally developed at Boston Children's Hospital, obtains CGM, insulin delivery, and activity data, from the cloud each day at approximately 8:00 PM using an Application Program Interface (API) calls to commercial companies (primarily Glooko and Tidepool) that aggregate data from different devices used to manage glucose levels in individuals. A detailed statistical and control analysis (see preliminary data study 1 for algorithm details) of the data are then conducted to determine if a change in therapy is required. If the analysis indicates a change in therapy is required, the patient or parent is notified by text or email directing then to a web portal detailing the change. The patient or parent can accept or modify the recommended change. If a change is made, the AIDA system confirms that the change is correctly implemented into the patient's pump or Bluetooth enabled pen when the patient next uploads the device data to the cloud.

DEVICE

Control

Standard Care - change in therapy settings effected at regularly scheduled patient visits

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Laura Nally, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-04-30
Completion
2023-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04259775 on ClinicalTrials.gov