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| Name | Class |
|---|---|
| General University Hospital, Prague | OTHER |
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The aim of the study was to investigate the switch between open-source automated insulin delivery system (OS-AID) - AndroidAPS (AAPS) and commercially available AID systems - Control-IQ (CIQ) and MiniMed 780G (780G) in extended follow-up study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control-IQ or Smartguard system | Experimental | Patients with use of the Control-IQ system or Smartguard system (closed-loop hybrid system) and previous users of AndroidAPS (closed-loop hybrid system) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin pump with closed-loop system | Device | Device: Usage of Insulin pump t:slim X2 with Control-IQ technology or MiniMed 780G with Smartguard 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] | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time in hypoglycemic range | <3.9 mmol/L [70 mg/dL] and <3.0 mmol/L [54 mg/dL] | 14 weeks |
| Percentage of time in hyperglycemic range | >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 | Affiliation | Role |
|---|---|---|
| Jan Soupal | 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University | Prague | Czech Republic | 12808 | 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. | |
| 37743832 | Background | 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. |
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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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|
| 14 weeks |
| Percentage of time in tight range | 3.9 mmol/L-7.8 mmol/l [70 mg/dL - 140 mg/dL] | 14 weeks |
| Changes in glycemic variability | Expressed as the coefficient of variation | 14 weeks |
| Icidence of severe hypoglycaemia | Requiring third-party assistance to treat | 14 weeks |
| Changes in glycated haemoglobin (HbA1c) | Differences between HbA1c values in the initial period and after follow-up | 14 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. | 14 weeks |
| Diabetec distress as assessed by validated questionnaire | The DDS17 yields a total diabetes distress score plus 4 subscale scores, each addressing a different kind of distress - Emotional Burden, Physician Distress, Regimen Distress, Interpersonal Distress. Scores in total and each subscales range between 1-21, higher scores denote higher distress. | 14 weeks |
| The 5-item World Health Organization well-being index as assessed by validated questionnaire | This questionnaire contains in total 5 questions. Scores in total range between 0-25, higher scores denote higher quality of life. | 14 weeks |
| 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. |
| 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. |
| 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |