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

Not Applicable

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT05165615
• Lead Sponsor: Charles University, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-11-23
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-14
• Last Update Submitted: 2021-12-14
• Study First Posted: 2021-12-21
• Last Update Posted: 2021-12-21
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of time in target ranges	Up to 28 weeks	3.9-10.0 mmol/L (70-180 mg/dl)

Secondary Outcome Measures

Name	Time	Method
Changes in glycemic variability	Up to 28 weeks	Expressed as the coefficient of variation
Changes in glycated haemoglobin (HbA1c)	Up to 28 weeks	Differences between HbA1c values in the initial period and after follow-up
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)
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)
Incidence of severe hypoglycaemia	Up to 28 weeks	Requiring third-party assistance to treat
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.
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).
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.

Trial Locations

Locations (1)

3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University; 🇨🇿 Prague, Czechia