Android Artificial Pancreas System (Android APS) Versus Control-IQ (CODIAC)
December 14, 2021 updated by: Jan Soupal, MD, Charles University, Czech Republic
Comparison of the Two Different Closed-loop Hybrid Systems - AndroidAPS and Control-IQ in Patients With Type 1 Diabetes
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jan Soupal
- Phone Number: +420775654343
- Email: jan.soupal@seznam.cz
Study Locations
-
-
-
Prague, Czechia
- Recruiting
- 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University
-
Contact:
- Jan Soupal
- Phone Number: +420775654343
- Email: jan.soupal@seznam.cz
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
|
Usage of Insulin pump t:slim X2 with Control-IQ technology in previous users of AndroidAPS
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of time in target ranges
Time Frame: Up to 28 weeks
|
3.9-10.0 mmol/L (70-180 mg/dl)
|
Up to 28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of time in hypoglycemic ranges
Time Frame: Up to 28 weeks
|
<3.9 mmol/L (70 mg/dl) and <3.0 mmol/L (54 mg/dl)
|
Up to 28 weeks
|
|
Percentage of time in hyperglycemic ranges
Time Frame: Up to 28 weeks
|
>10.0 mmol/L (180 mg/dl) and >13.9 mmol/L (250 mg/dl)
|
Up to 28 weeks
|
|
Changes in glycemic variability
Time Frame: Up to 28 weeks
|
Expressed as the coefficient of variation
|
Up to 28 weeks
|
|
Incidence of severe hypoglycaemia
Time Frame: Up to 28 weeks
|
Requiring third-party assistance to treat
|
Up to 28 weeks
|
|
Changes in glycated haemoglobin (HbA1c)
Time Frame: Up to 28 weeks
|
Differences between HbA1c values in the initial period and after follow-up
|
Up to 28 weeks
|
|
Hypoglycemia Attitudes and Behavior Scale (HABS)
Time Frame: 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.
|
Up to 28 weeks
|
|
Diabetes Distress Scale (DDS)
Time Frame: 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.
|
Up to 28 weeks
|
|
The 5-item World Health Organization well-being index (WHO-5 index)
Time Frame: 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).
|
Up to 28 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jan Soupal, Charles University, Prague
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
November 23, 2021
First Submitted That Met QC Criteria
December 14, 2021
First Posted (Actual)
December 21, 2021
Study Record Updates
Last Update Posted (Actual)
December 21, 2021
Last Update Submitted That Met QC Criteria
December 14, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CODIAC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.