Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1485 for:    Type 1 Diabetes Mellitus 5
Previous Study | Return to List | Next Study

Clinical Assessment of a Novel Advanced Bolus Calculator for Type 1 Diabetes 5 (ABC4D5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03963219
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Imperial College London

Brief 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


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: ABC4D Device: Standard Bolus Calculator Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomised controlled non-inferiority crossover study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Assessment of a Novel Advanced Bolus Calculator for Type 1 Diabetes 5
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: 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: 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).

Active Comparator: Standard Bolus Calculator
Standard bolus calculator
Device: Standard Bolus Calculator
Standard bolus calculator




Primary Outcome Measures :
  1. % Time blood glucose in target, day time assess by device [ Time Frame: 32 weeks ]
    % time blood glucose spent in target (3.9-10mmol/L, 70-180mg/dL) during daytime (0700-2200)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults over 18 years of age
  • HbA1c between 7.0% and 9.0%
  • Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide <200 pmol/L
  • Type 1 diabetes for greater than 3 years
  • On an intensified multiple dose insulin injection regimen for > 6 months (MDI)
  • Structured education (either group or 1:1)

Exclusion Criteria:

  • Pregnant or planning pregnancy
  • Breastfeeding
  • Enrolled in other clinical trials
  • Have active malignancy or under investigation for malignancy
  • Severe visual impairment
  • Reduced manual dexterity
  • Unable to participate due to other factors, as assessed by the Chief Investigator
  • Shift worker
  • Allergy or intolerance to insulin aspart

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963219


Contacts
Layout table for location contacts
Contact: Monika Reddy 020 3312 6037 m.reddy@imperial.ac.uk

Locations
Layout table for location information
United Kingdom
Imperial College Clinical Research Facility Recruiting
London, United Kingdom, W12 0HS
Contact: Monika Reddy       m.reddy@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
DexCom, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Monika Reddy Imperial College London

Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03963219     History of Changes
Other Study ID Numbers: 15SM2847
DOCUMAS NUMBER ( Other Identifier: 15SM2847 )
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Type 1 Diabetes Mellitus
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases