Type 1 DiabetesUNIQUENCT05118945
Study on the Use of the Insulin Pump Tandem X:2 With Control IQ Algorithm - Update
An observational study of Type 1 Diabetes and Insulin Therapy, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
Trial summary
The aim of this observational clinical trial is to obtain data on the safety, efficacy and satisfaction of the Tandem T:Slim X:2 Pump System in patients with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 6 to 45 years
- Conditions the study is for
- Type 1 Diabetes, Insulin Therapy
- What is being tested?
- Insulin pump Tandem: t:slim X2
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 3 Mar 2021to 28 Dec 2021
- Phase
- Observational
- 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 6 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients over 6 years of age with type 1 Diabetes and Insulin therapy (MDI or CSII). The START group is heterogeneous, but it should be ensured that all patients in the start group do not use a close loop system so far. Furthermore, a maximum of 30 % of the patients in the START group should use the same pump system to ensure that the weighting of a single pump system does not become too strong.
Who may be able to join
- signed informed consent
- type 1 diabetes
- Age >6 years
- at least 10 IE daily total Insulin dose and 25 kg Body weight
- Group SWITCH: already user of t:slim X2 with Basal IQ
- Group START: Granting of the insulin pump t:slim X2 and DexCom G6 by the health insurance
Who cannot join
- 1.Refusal of participation by the participant or a parent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hospital for Children and Adolescents AUF DER BULT
Hanover, Lower Saxony, 30173
About this study
Official title: Observational Study on the Use of the Insulin Pump Tandem X:2 With Control IQ Algorithm - Update
The aim of this observational clinical trial is to obtain data on the safety, efficacy and satisfaction of the Tandem T:Slim X:2 Pump System in patients with type 1 diabetes.
Read the detailed description
This is a non-randomized, non-blinded, prospective, observational single-center study, enrolling 2x 25 subjects in two cohorts (25 subjects in SWITCH group and 25 subjects in START group) with diabetes mellitus for up to 12 weeks. The study will evaluate the effectiveness of the insulin therapy with the pump system Tandem t:slim X:2 with the special algorithm "Control IQ" in comparison to each other. The test system including the Control IQ software will provide an Hybrid-Closed loop - Modus, which can predict the future tissue glucose value and continuously adjust the insulin infusion according to need. The aim is to keep the glucose value permanently within the target range and to avoid hypoglycaemia or hyperglycaemia.
Group START starts from any other diabetes therapy (MDI, PLGM (=Predictive Low Glucose Suspend), SaP (=Sensor augmented Pump)) directly to T:Slim pump with control IQ; group SWITCH switches from former use of T:slim with Basal IQ.
The study includes two visits only (start and end). At the beginning all patients have to complete questionnaires, and the data of the glucose sensor are read out and the metric data are determined and laid down.
Depending on the previous form of therapy, the patients are assigned to the corresponding cohort. All participants and parents, regardless of which cohort, receive a technical briefing from the study team as well as training on how to use the new system or algorithm. Subsequently, the system will be applied in everyday life in the coming weeks. After 12 weeks (end of study), the insulin pump is read out and the questionnaire on satisfaction with the device is filled out again.
After the end of the study, the patients participate in standard medical care as before.
- Conditions
- Type 1 Diabetes, Insulin Therapy
- Being tested
- Insulin pump Tandem: t:slim X2
- Keywords
- paediatrics, type 1 diabetes, closed loop, CSII (Continuous Subcutaneous Insulin Infusion)
- 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 Tandem: t:slim X2Device
Also called Insulin pump Tandem: t:slim X2 with Control IQ
Insulin pump with Hybrid-Closed Loop - Modus. The insulin pump t:slim X2 from the manufacturer Tandem, in cooperation with the glucose sensor DexCom G6, has the option of using an algorithm called "control IQ", which controls the insulin delivery semi-automatically by means of an MPC algorithm. For this purpose, the insulin basal delivery can be increased or decreased by the system. Furthermore, automatic bolus deliveries, which are possible in the amount of up to 60% of a manual correction, can be delivered.
| Study group | Role | What they receive |
|---|---|---|
| SWITCH group: Change from Basal IQ to Control IQ | The patients of the SWITCH group used the X:s insulin pump with the "Basal IQ" algorithm until the start of the study and switched to the "Control IQ" algorithm at study start. Receives: Device: Insulin pump Tandem: t:slim X2 | |
| START group: Change from conservative therapy to Control IQ | The patients of the START group have a conservative Insulin therapy (MDI = multiple daily injections or CSII = Continuous subcutaneous insulin infusion) until the start of the study, but will switched to the "Control IQ" algorithm at study start. Receives: Device: Insulin pump Tandem: t:slim X2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in glucose range 70 - 180mg/dl (%)
Both groups are evaluated together. Comparison of the time (%) in the glucose range 70 - 180mg/dl of the last two weeks of the study with the time in the target range two weeks before the start of the study.
Measured: 12 weeks
Secondary outcomes (6)
user satisfaction assessed by disabkids questionnaire for children and for parents
Comparison of both groups with regard to satisfaction via specific validated questionnaire at the start of the study
Measured: two weeks
user satisfaction assessed by disabkids questionnaire for children and for parents
Evaluation of the satisfaction of users via specific validated questionnare at the beginning and the end of study
Measured: 12 weeks
mean glucose level [mg/dl]
Comparison of the mean Glucose Level from glucose sensor [mg/dl] of the last two study weeks with the mean glucose Level two weeks before the start of the study.
Measured: two weeks
mean glucose Level before study start [mg/dl]
Comparison of both groups concerning the mean glucose level of the two weeks before the start of the study.
Measured: two weeks
mean daily insulin amount
Both groups are evaluated together. Comparison of the mean daily insulin amount (U/kgBW/d) (U/kgBW/d) of the last two study weeks with the insulin amount two weeks before the start of the study.
Measured: 12 weeks
mean daily insulin amount before study start
Comparison of both groups concerning the mean daily insulin amount (U/kgBW/d) of the two weeks before the start of the study.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start3 Mar 2021
- Primary completion28 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinderkrankenhaus auf der Bult
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torben Biester, Dr., Principal investigator, Hospital for Children and Adolescents AUF DER BULT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118945
- Sponsor's protocol ID
- Unique_1_2021
- Acronym
- UNIQUE
- Status last verified
- Sep 2024
- First submitted
- 12 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Use of the Insulin Pump Tandem X:2 With Control IQ Algorithm - Update
- ClinicalTrials.gov ID
- NCT05118945
- Acronym / sponsor ID
- UNIQUE / Unique_1_2021
- Conditions
- Type 1 Diabetes, Insulin Therapy
- Keywords
- paediatrics, type 1 diabetes, closed loop, CSII (Continuous Subcutaneous Insulin Infusion)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kinderkrankenhaus auf der BultUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 12 Nov 2021 (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 this observational clinical trial is to obtain data on the safety, efficacy and satisfaction of the Tandem T:Slim X:2 Pump System in patients with type 1 diabetes.
Detailed description
This is a non-randomized, non-blinded, prospective, observational single-center study, enrolling 2x 25 subjects in two cohorts (25 subjects in SWITCH group and 25 subjects in START group) with diabetes mellitus for up to 12 weeks. The study will evaluate the effectiveness of the insulin therapy with the pump system Tandem t:slim X:2 with the special algorithm "Control IQ" in comparison to each other. The test system including the Control IQ software will provide an Hybrid-Closed loop - Modus, which can predict the future tissue glucose value and continuously adjust the insulin infusion according to need. The aim is to keep the glucose value permanently within the target range and to avoid hypoglycaemia or hyperglycaemia.
Group START starts from any other diabetes therapy (MDI, PLGM (=Predictive Low Glucose Suspend), SaP (=Sensor augmented Pump)) directly to T:Slim pump with control IQ; group SWITCH switches from former use of T:slim with Basal IQ.
The study includes two visits only (start and end). At the beginning all patients have to complete questionnaires, and the data of the glucose sensor are read out and the metric data are determined and laid down.
Depending on the previous form of therapy, the patients are assigned to the corresponding cohort. All participants and parents, regardless of which cohort, receive a technical briefing from the study team as well as training on how to use the new system or algorithm. Subsequently, the system will be applied in everyday life in the coming weeks. After 12 weeks (end of study), the insulin pump is read out and the questionnaire on satisfaction with the device is filled out again.
After the end of the study, the patients participate in standard medical care as before.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SWITCH group: Change from Basal IQ to Control IQ | – | Device: Insulin pump Tandem: t:slim X2The patients of the SWITCH group used the X:s insulin pump with the "Basal IQ" algorithm until the start of the study and switched to the "Control IQ" algorithm at study start. |
| START group: Change from conservative therapy to Control IQ | – | Device: Insulin pump Tandem: t:slim X2The patients of the START group have a conservative Insulin therapy (MDI = multiple daily injections or CSII = Continuous subcutaneous insulin infusion) until the start of the study, but will switched to the "Control IQ" algorithm at study start. |
Who may qualify
- Ages
- 6 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients over 6 years of age with type 1 Diabetes and Insulin therapy (MDI or CSII). The START group is heterogeneous, but it should be ensured that all patients in the start group do not use a close loop system so far. Furthermore, a maximum of 30 % of the patients in the START group should use the same pump system to ensure that the weighting of a single pump system does not become too strong.
Key inclusion criteria (6 listed)
- signed informed consent
- type 1 diabetes
- Age >6 years
- at least 10 IE daily total Insulin dose and 25 kg Body weight
- Group SWITCH: already user of t:slim X2 with Basal IQ
Key exclusion criteria (1 listed)
- 1.Refusal of participation by the participant or a parent
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 Tandem: t:slim X2Also: Insulin pump Tandem: t:slim X2 with Control IQInsulin pump with Hybrid-Closed Loop - Modus. The insulin pump t:slim X2 from the manufacturer Tandem, in cooperation with the glucose sensor DexCom G6, has the option of using an algorithm called "control IQ", which controls the insulin delivery semi-automatically by means of an MPC algorithm. For this purpose, the insulin basal delivery can be increased or decreased by the system. Furthermore, automatic bolus deliveries, which are possible in the amount of up to 60% of a manual correction, can be delivered. | Device | START group: Change from conservative therapy to Control IQ, SWITCH group: Change from Basal IQ to Control IQ |
Primary outcome
Time in glucose range 70 - 180mg/dl (%)
Time frame: 12 weeks
Both groups are evaluated together. Comparison of the time (%) in the glucose range 70 - 180mg/dl of the last two weeks of the study with the time in the target range two weeks before the start of the study.
6 secondary outcomes
user satisfaction assessed by disabkids questionnaire for children and for parents
Time frame: two weeks
user satisfaction assessed by disabkids questionnaire for children and for parents
Time frame: 12 weeks
mean glucose level [mg/dl]
Time frame: two weeks
mean glucose Level before study start [mg/dl]
Time frame: two weeks
mean daily insulin amount
Time frame: 12 weeks
mean daily insulin amount before study start
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Torben Biester, Dr. principal investigator
Hospital for Children and Adolescents AUF DER BULT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Insulin Therapy, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time in glucose range 70 - 180mg/dl (%) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.