Diabetes Mellitus, Type 1NCT06709729
Switch of AndroidAPS to Commercially Available AID Systems
A study testing Insulin pump with closed-loop system in people with Diabetes Mellitus, Type 1, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin pump with closed-loop system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Dec 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- nonadherence to the current treatment regimen
- lactation
- pregnancy
- intending to become pregnant during study
- concomitant therapy influencing glucose metabolism
Trial locations and contacts
1 site in 1 country.
Czechia1 site
3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University
Prague, Czech Republic, 12808
About this study
Official title: Switch of Open-source Automated Insulin Delivery System - AndroidAPS to Commercially Available AID Systems in Type 1 Diabetes: the Extension of the CODIAC Study
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin pump with closed-loop system
- Keywords
- Insulin Pump, Closed-loop hybrid system, Continuous Glucose Monitoring, Automated Insulin Delivery
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin pump with closed-loop systemDevice
Also called Insulin pump t:slim X2 with Control-IQ technology, Insulin pump MiniMed 780G with Smartguard technology in previous users of AndroidAPS
Device: Usage of Insulin pump t:slim X2 with Control-IQ technology or MiniMed 780G with Smartguard technology in previous users of AndroidAPS
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Insulin pump with closed-loop system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time in target ranges
3.9-10.0 mmol/L [70-180 mg/dL]
Measured: 14 weeks
Secondary outcomes (9)
Percentage of time in hypoglycemic range
<3.9 mmol/L [70 mg/dL] and <3.0 mmol/L [54 mg/dL]
Measured: 14 weeks
Percentage of time in hyperglycemic range
>10,0 mmol/L [180 mg/dL] and >13,9 mmol/L [250 mg/dL]
Measured: 14 weeks
Percentage of time in tight range
3.9 mmol/L-7.8 mmol/l [70 mg/dL - 140 mg/dL]
Measured: 14 weeks
Changes in glycemic variability
Expressed as the coefficient of variation
Measured: 14 weeks
Icidence of severe hypoglycaemia
Requiring third-party assistance to treat
Measured: 14 weeks
Changes in glycated haemoglobin (HbA1c)
Differences between HbA1c values in the initial period and after follow-up
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Dec 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- General University Hospital, Prague
- Responsible party
- Sponsor
- Investigators
- Jan Soupal, Principal investigator, 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709729
- Sponsor's protocol ID
- CODIAC Extension
- Status last verified
- Sep 2024
- First submitted
- 2 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 23072401Do 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.
PubMed 37743832Haskova 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.
PubMed 32859607Soupal 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.
PubMed 27482825Soupal 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.
PubMed 31530663
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch of Open-source Automated Insulin Delivery System - AndroidAPS to Commercially Available AID Systems in Type 1 Diabetes: the Extension of the CODIAC Study
- ClinicalTrials.gov ID
- NCT06709729
- Acronym / sponsor ID
- CODIAC Extension
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Insulin Pump, Closed-loop hybrid system, Continuous Glucose Monitoring, Automated Insulin Delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- General University Hospital, Prague
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control-IQ or Smartguard system | Experimental | Device: Insulin pump with closed-loop systemPatients with use of the Control-IQ system or Smartguard system (closed-loop hybrid system) and previous users of AndroidAPS (closed-loop hybrid system) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- nonadherence to the current treatment regimen
- lactation
- pregnancy
- intending to become pregnant during study
- concomitant therapy influencing glucose metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin pump with closed-loop systemAlso: Insulin pump t:slim X2 with Control-IQ technology, Insulin pump MiniMed 780G with Smartguard technology in previous users of AndroidAPSDevice: Usage of Insulin pump t:slim X2 with Control-IQ technology or MiniMed 780G with Smartguard technology in previous users of AndroidAPS | Device | Control-IQ or Smartguard system |
Primary outcome
Percentage of time in target ranges
Time frame: 14 weeks
3.9-10.0 mmol/L [70-180 mg/dL]
9 secondary outcomes
Percentage of time in hypoglycemic range
Time frame: 14 weeks
Percentage of time in hyperglycemic range
Time frame: 14 weeks
Percentage of time in tight range
Time frame: 14 weeks
Changes in glycemic variability
Time frame: 14 weeks
Icidence of severe hypoglycaemia
Time frame: 14 weeks
Changes in glycated haemoglobin (HbA1c)
Time frame: 14 weeks
Hypoglycemia Attitudes and Behavior Scale (HABS)
Time frame: 14 weeks
Diabetec distress as assessed by validated questionnaire
Time frame: 14 weeks
The 5-item World Health Organization well-being index as assessed by validated questionnaire
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 23072401Hajos 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.
- Background: PubMed 37743832Do 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.
- Background: PubMed 32859607Haskova 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.
- Background: PubMed 27482825Soupal 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.
- Background: PubMed 31530663Soupal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Soupal principal investigator
3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin pump with closed-loop system in people with Diabetes Mellitus, Type 1, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time in target ranges (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06709729, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.