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CODIAC: Android Artificial Pancreas System (Android APS) Versus Control-IQ

Sponsor
Charles University, Czech Republic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05165615
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
25
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the investigator's study is to compare two different closed loop hybrid systems - certified Control-IQ and noncertified AndroidAPS in adult patients with Type 1 Diabetes (T1D), who had been using AndroidAPS previously from their own decision, during 12 weeks of follow-up.

Condition or Disease Intervention/Treatment Phase
  • Device: Insulin Pump t:slim X2 with Control-IQ technology
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Comparison of the Two Different Closed-loop Hybrid Systems - AndroidAPS and Control-IQ in Patients With Type 1 Diabetes
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: AndroidAPS versus Control-IQ

Patients with use of the Control-IQ system (closed-loop hybrid system) and previous users of AndroidAPS (closed-loop hybrid system)

Device: Insulin Pump t:slim X2 with Control-IQ technology
Usage of Insulin pump t:slim X2 with Control-IQ technology in previous users of AndroidAPS
Other Names:
  • Continuous Glucose Monitoring Dexcom G6 system

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of time in target ranges [Up to 28 weeks]

      3.9-10.0 mmol/L (70-180 mg/dl)

    Secondary Outcome Measures

    1. Percentage of time in hypoglycemic ranges [Up to 28 weeks]

      <3.9 mmol/L (70 mg/dl) and <3.0 mmol/L (54 mg/dl)

    2. Percentage of time in hyperglycemic ranges [Up to 28 weeks]

      >10.0 mmol/L (180 mg/dl) and >13.9 mmol/L (250 mg/dl)

    3. Changes in glycemic variability [Up to 28 weeks]

      Expressed as the coefficient of variation

    4. Incidence of severe hypoglycaemia [Up to 28 weeks]

      Requiring third-party assistance to treat

    5. Changes in glycated haemoglobin (HbA1c) [Up to 28 weeks]

      Differences between HbA1c values in the initial period and after follow-up

    6. Hypoglycemia Attitudes and Behavior Scale (HABS) [Up to 28 weeks]

      This validated questionnaire contains in total 14 questions that highlights two critical dimensions of hypoglycemia-related concerns (anxiety and avoidance) and one positive dimension (confidence). 14 items use Likert scales from 1 to 5, total score from 14 to 70, the higher total score means worse outcome.

    7. Diabetes Distress Scale (DDS) [Up to 28 weeks]

      This validated questionnaire assess diabetes-related emotional stress. This 17-item tool uses the Likert scales from 1 to 6. Total score is from 17 to 102, while higher total score means worse outcome.

    8. The 5-item World Health Organization well-being index (WHO-5 index) [Up to 28 weeks]

      This validated questionnaire contains in total 5 questions with Likert scales from 5 to 0. Total score is multiplied by 4 to give a final score ranging from 0 to 100, higher score denote higher quality of life (better outcome).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Type 1 diabetes diagnosed >2 years

    • ≥ 18 years old

    • written informed consent prior to starting study related activity

    • previous user of AndroidAPS at least for 3 months

    Exclusion Criteria:

    • severe noncompliance

    • lactation, pregnancy, intending to become pregnant during study

    • use of medication with effects on carbohydrate metabolism

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University Prague Czechia

    Sponsors and Collaborators

    • Charles University, Czech Republic

    Investigators

    • Principal Investigator: Jan Soupal, Charles University, Prague

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jan Soupal, MD, Principal Investigator, Charles University, Czech Republic
    ClinicalTrials.gov Identifier:
    NCT05165615
    Other Study ID Numbers:
    • CODIAC
    First Posted:
    Dec 21, 2021
    Last Update Posted:
    Dec 21, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Jan Soupal, MD, Principal Investigator, Charles University, Czech Republic
    Continuous Glucose Monitoring
    Insulin Pump
    Closed-loop hybrid system
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 1
    Insulin

    Study Results

    No Results Posted as of Dec 21, 2021