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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Recruiting

Phase

Not Applicable

Locations

Czechia

Study Type

Interventional

Intervention

Insulin Pump t:slim X2 with Control-IQ technology

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Continuous Glucose Monitoring, Insulin Pump, Closed-loop hybrid system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AndroidAPS versus Control-IQ

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of time in target ranges

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

Secondary Outcome Measures

Percentage of time in hypoglycemic ranges

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

Percentage of time in hyperglycemic ranges

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

Changes in glycemic variability

Expressed as the coefficient of variation

Incidence of severe hypoglycaemia

Requiring third-party assistance to treat

Changes in glycated haemoglobin (HbA1c)

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

Hypoglycemia Attitudes and Behavior Scale (HABS)

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.

Diabetes Distress Scale (DDS)

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.

The 5-item World Health Organization well-being index (WHO-5 index)

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).

Full Information

NCT ID

NCT05165615

First Posted

November 23, 2021

Last Updated

December 14, 2021

Sponsor

Charles University, Czech Republic

1. Study Identification

Unique Protocol Identification Number

NCT05165615

Brief Title

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

Acronym

CODIAC

Official Title

Comparison of the Two Different Closed-loop Hybrid Systems - AndroidAPS and Control-IQ in Patients With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

Continuous Glucose Monitoring, Insulin Pump, Closed-loop hybrid system

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AndroidAPS versus Control-IQ

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Insulin Pump t:slim X2 with Control-IQ technology

Other Intervention Name(s)

Continuous Glucose Monitoring Dexcom G6 system

Intervention Description

Usage of Insulin pump t:slim X2 with Control-IQ technology in previous users of AndroidAPS

Primary Outcome Measure Information:

Title

Percentage of time in target ranges

Description

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

Time Frame

Up to 28 weeks

Secondary Outcome Measure Information:

Title

Percentage of time in hypoglycemic ranges

Description

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

Time Frame

Up to 28 weeks

Title

Percentage of time in hyperglycemic ranges

Description

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

Time Frame

Up to 28 weeks

Title

Changes in glycemic variability

Description

Expressed as the coefficient of variation

Time Frame

Up to 28 weeks

Title

Incidence of severe hypoglycaemia

Description

Requiring third-party assistance to treat

Time Frame

Up to 28 weeks

Title

Changes in glycated haemoglobin (HbA1c)

Description

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

Time Frame

Up to 28 weeks

Title

Hypoglycemia Attitudes and Behavior Scale (HABS)

Description

Time Frame

Up to 28 weeks

Title

Diabetes Distress Scale (DDS)

Description

Time Frame

Up to 28 weeks

Title

The 5-item World Health Organization well-being index (WHO-5 index)

Description

Time Frame

Up to 28 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jan Soupal

Phone

+420775654343

jan.soupal@seznam.cz

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Soupal

Organizational Affiliation

Charles University, Prague

Official's Role

Principal Investigator

Facility Information:

Facility Name

3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University

City

Prague

Country

Czechia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jan Soupal

Phone

+420775654343

jan.soupal@seznam.cz

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23072401

Citation

Hajos TR, Pouwer F, Skovlund SE, Den Oudsten BL, Geelhoed-Duijvestijn PH, Tack CJ, Snoek FJ. Psychometric and screening properties of the WHO-5 well-being index in adult outpatients with Type 1 or Type 2 diabetes mellitus. Diabet Med. 2013 Feb;30(2):e63-9. doi: 10.1111/dme.12040.

Results Reference

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PubMed Identifier

22228744

Citation

Fisher L, Hessler DM, Polonsky WH, Mullan J. When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale. Diabetes Care. 2012 Feb;35(2):259-64. doi: 10.2337/dc11-1572. Epub 2012 Jan 6.

Results Reference

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PubMed Identifier

32354623

Citation

Polonsky WH, Fisher L, Hessler D, Liu J, Fan L, McAuliffe-Fogarty AH. Worries and concerns about hypoglycemia in adults with type 1 diabetes: An examination of the reliability and validity of the Hypoglycemic Attitudes and Behavior Scale (HABS). J Diabetes Complications. 2020 Jul;34(7):107606. doi: 10.1016/j.jdiacomp.2020.107606. Epub 2020 Apr 23.

Results Reference

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PubMed Identifier

31530663

Citation

Soupal J, Petruzelkova L, Grunberger G, Haskova A, Flekac M, Matoulek M, Mikes O, Pelcl T, Skrha J Jr, Horova E, Skrha J, Parkin CG, Svacina S, Prazny M. Glycemic Outcomes in Adults With T1D Are Impacted More by Continuous Glucose Monitoring Than by Insulin Delivery Method: 3 Years of Follow-Up From the COMISAIR Study. Diabetes Care. 2020 Jan;43(1):37-43. doi: 10.2337/dc19-0888. Epub 2019 Sep 17.

Results Reference

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PubMed Identifier

27482825

Citation

Soupal J, Petruzelkova L, Flekac M, Pelcl T, Matoulek M, Dankova M, Skrha J, Svacina S, Prazny M. Comparison of Different Treatment Modalities for Type 1 Diabetes, Including Sensor-Augmented Insulin Regimens, in 52 Weeks of Follow-Up: A COMISAIR Study. Diabetes Technol Ther. 2016 Sep;18(9):532-8. doi: 10.1089/dia.2016.0171. Epub 2016 Aug 2.

Results Reference

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PubMed Identifier

32859607

Citation

Haskova A, Radovnicka L, Petruzelkova L, Parkin CG, Grunberger G, Horova E, Navratilova V, Kade O, Matoulek M, Prazny M, Soupal J. Real-time CGM Is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 Diabetes: The CORRIDA Randomized Controlled Trial. Diabetes Care. 2020 Nov;43(11):2744-2750. doi: 10.2337/dc20-0112. Epub 2020 Aug 28.

Results Reference

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

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