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

Diabetes Mellitus, Type 1 Clinical Trial

— CODIAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05165615
• Other study ID #: CODIAC
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2021
• Source: Charles University, Czech Republic
• Contact: Jan Soupal
• Phone: +420775654343
• Email: jan.soupal[@]seznam.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (6)

Šoupal J, Petruželková L, Flekac M, Pelcl T, Matoulek M, Danková M, Škrha J, Svacina Š, Prázný 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. — View Citation

Šoupal J, Petruželková L, Grunberger G, Hásková A, Flekac M, Matoulek M, Mikeš O, Pelcl T, Škrha J Jr, Horová E, Škrha J, Parkin CG, Svacina Š, Prázný 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. — View 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. — View 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. — View Citation

Hásková A, Radovnická L, Petruželková L, Parkin CG, Grunberger G, Horová E, Navrátilová V, Káde O, Matoulek M, Prázný M, Šoupal 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time in target ranges	3.9-10.0 mmol/L (70-180 mg/dl)	Up to 28 weeks
Secondary	Percentage of time in hypoglycemic ranges	<3.9 mmol/L (70 mg/dl) and <3.0 mmol/L (54 mg/dl)	Up to 28 weeks
Secondary	Percentage of time in hyperglycemic ranges	>10.0 mmol/L (180 mg/dl) and >13.9 mmol/L (250 mg/dl)	Up to 28 weeks
Secondary	Changes in glycemic variability	Expressed as the coefficient of variation	Up to 28 weeks
Secondary	Incidence of severe hypoglycaemia	Requiring third-party assistance to treat	Up to 28 weeks
Secondary	Changes in glycated haemoglobin (HbA1c)	Differences between HbA1c values in the initial period and after follow-up	Up to 28 weeks
Secondary	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.	Up to 28 weeks
Secondary	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.	Up to 28 weeks
Secondary	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).	Up to 28 weeks