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Clinical Assessment of a Novel Advanced Bolus Calculator for Type 1 Diabetes 5

NCT03963219 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2020-10-22

No results posted yet for this study

Summary

The main objective of this study is to assess safety and efficacy of the ABC4D compared to standard therapy (standard bolus calculator) in adults with type 1 diabetes on multiple daily injections (MDI) of insulin in an out-of-clinic setting.

Hypothesis: ABC4D is non-inferior to a standard bolus calculator and has an equivalent impact on time in target in adults with type 1 diabetes on MDI

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

ABC4D

The complete integrated system consists of a smartphone that holds the advanced decision support algorithm. The system requires regular updates of cases derived from continuous glucose monitoring (CGM) data. Each new case includes information about the problem (e.g. capillary blood glucose, meal information and physical exercise), solution (recommended insulin dose) and outcome (post-prandial blood glucose).

DEVICE

Standard Bolus Calculator

Standard bolus calculator

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • Imperial College London

    lead OTHER

Principal Investigators

  • Monika Reddy · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • United Kingdom

Study Locations

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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 NCT03963219 on ClinicalTrials.gov