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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AndroidAPS versus Control-IQ | Experimental | Patients with use of the Control-IQ system (closed-loop hybrid system) and previous users of AndroidAPS (closed-loop hybrid system) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Pump t:slim X2 with Control-IQ technology | Device | Usage of Insulin pump t:slim X2 with Control-IQ technology in previous users of AndroidAPS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time in target ranges | 3.9-10.0 mmol/L (70-180 mg/dl) | Up to 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percentage of time in hyperglycemic ranges | >10.0 mmol/L (180 mg/dl) and >13.9 mmol/L (250 mg/dl) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Soupal | Contact | +420775654343 | jan.soupal@seznam.cz |
| Name | Affiliation | Role |
|---|---|---|
| Jan Soupal | Charles University, Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University | Recruiting | Prague | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23072401 | Background | 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. | |
| 22228744 | Background | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Up to 28 weeks |
| Changes in glycemic variability | Expressed as the coefficient of variation | Up to 28 weeks |
| Incidence of severe hypoglycaemia | Requiring third-party assistance to treat | Up to 28 weeks |
| Changes in glycated haemoglobin (HbA1c) | Differences between HbA1c values in the initial period and after follow-up | Up to 28 weeks |
| 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 |
| 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 |
| 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 |
| 32354623 | Background | 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. |
| 31530663 | Background | 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. |
| 27482825 | Background | 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. |
| 32859607 | Background | 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. |
| 37743832 | Derived | Do QD, Haskova A, Radovnicka L, Konecna J, Horova E, Parkin CG, Grunberger G, Prazny M, Soupal J. Comparison of Control-IQ and open-source AndroidAPS automated insulin delivery systems in adults with type 1 diabetes: The CODIAC study. Diabetes Obes Metab. 2024 Jan;26(1):78-84. doi: 10.1111/dom.15289. Epub 2023 Sep 25. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |