Type 1 DiabetesSTARCARENCT05969106
Tandem Control-IQ Evaluation Regarding Glucose Metrics, Sleep, and Health Economics
An observational study of Type 1 Diabetes, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
To evaluate Tandem Control-IQ compared with rtCGM and insulin pen respectively rtCGM and insulin pump treatment in children and adolescents regarding glucose control, sleep and health economics for 18 months. Read more about this study
- Who is it for?
- Ages 2 to 19 years
- Conditions the study is for
- Type 1 Diabetes
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 84 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to 30 Dec 2022
- 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 2 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Individuals diagnosed with Type 1 diabetes at two different pediatric diabetes centres.
Who may be able to join
- Age between 2-19 years at the start
- Diagnosed with Type 1 diabetes
- Min duration three months
- Willingness to participate in the study
Who cannot join
- Pregnancy
- Unwillingness to share and upload CGM data
- Reluctance to come to visit and to follow protocol
- History of allergic reaction to Dexcom CGM materials or adhesives in contact with the skin.
- Abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
The hospital of Halland Kungsbacka
Kungsbacka, Region of Halland, 43480
About this study
Official title: A Study Comparing Tandem Control-IQ With Real-time Continuous Glucose Monitoring (rtCGM) Used Together With Insulin Pens and Insulin Pumps for 18 Months
To evaluate Tandem Control-IQ compared with rtCGM and insulin pen respectively rtCGM and insulin pump treatment in children and adolescents regarding glucose control, sleep and health economics for 18 months.
Read the detailed description
In this obesrvational study, the investigators assessed glycemic outcomes, sleep and health economics associated with AID treatment (Tandem Control-IQ) compared with multiple daily insulin injections with rtCGM (MDI+rtCGM) and a standalone insulin pump with rtCGM (CSII+rtCGM). Participants from two clinical sites in Sweden who continuously used one of the three modalities for at least six months were included in the analysis. Inclusion required all participants to use the Dexcom G6 rtCGM sensor for glucose monitoring, which meant only insulin treatment differentiated the three groups. Comparisons were conducted regarding Hemoglobon A1c (HbA1c) at the start of the study and rtCGM-generated glycemic metrics from 1 month before the study started until 18 months. Sleep quality and quantity were assessed using a questionnaire for the persons with diabetes and the caretakers. Indirect and direct costs in all healthcare systems and additional information on sick leaves were collected from the Swedish Social Insurance Agency. Comparisons were then made between the three treatment alternatives.
- Conditions
- Type 1 Diabetes
- Being tested
- Tandem Control-IQ
- 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.
Tandem Control-IQDevice
AID-system
| Study group | Role | What they receive |
|---|---|---|
| rtCGM + MDI | Real-time CGM Dexcom G6 used in parallel to Multiple Daily Injections (MDI) Receives: Device: Tandem Control-IQ | |
| rtCGM + CSII | Real-time CGM Dexcom G6 used in parallel to freestanding Continuous Subcutaneous Insulin Infusion (CSII) Receives: Device: Tandem Control-IQ | |
| Tandem Control-IQ | Realtime CGM Dexcom G6 used as part of the Automated Insulin Delivery (AID) system Receives: Device: Tandem Control-IQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic metrics
Time in range (TIR), Time below range (TBR) Level 1 and 2, Time above range (TAR) Level 1 and 2, Time in tighter range (TITR)
Measured: Change from baseline to 6, 12 and 18 months
Sleep
Quantity and quality are defined in the questionnaire. Assessment by a 10-point Likert scale (1= "Worst possible", 10= "Best possible")
Measured: At study completion at 12 months.
Costs - direct
Cost for the insulin administration devices and continuous glucose monitoring devices per person/year (direct). All costa are calculated in Swedish currency (SEK).
Measured: From baseline until study completion at 18 months
Costs - indirect
Cost for comorbidities and all health-care related costs (indirect), including societal costs based on days with sick-leaves (indirect). All costs are calculated in Swedish currency (SEK).
Measured: From baseline until study completion at 18 months
Quality Adjusted Life Year (QALY)
Quality Adjusted Life Year is estimated for each health state by literature search and for each of the three treatment alternatives. QALY is a generic measure of disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the value of medical interventions. One QALY equates to one year in perfect health. QALY scores range from 1 (perfect health) to 0 (dead). Thus, a higher value means a better outcome.
Measured: From baseline until study completion at 18 months.
Cost/QALY
Cost/QALY is estimated for each health state by literature search and for each of the three treatment alternatives. Cost/QALY is illustrating the cost per disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the cost per value of medical interventions. A lower value means a better outcome.
Measured: From baseline until study completion at 18 months.
Incremental Cost Efficiency Rate (ICER)
Based on glucose control cost-effect pairs is generated for Tandem Control-IQ vs. MDI respectively Tandem-Control-IQ vs. CSII. An ICER is calculated by dividing the difference in total costs (incremental cost) by the difference in the chosen measure of health outcome or effect (incremental effect) to provide a ratio of 'extra cost per extra unit of health effect' - for therapy A vs therapy B. A higher value means a better outcome. A prediction is added 10-, 20-, and 30-years ahead. ICER is estimated for these three time intervals.
Measured: From baseline until study completion at 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jan 2020
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Johan Peter Adolfsson, Vastra Gotaland Region
- Investigators
- Peter Adolfsson, MD PhD, Principal investigator, Västra Götalandsregionen, Gothenburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969106
- Sponsor's protocol ID
- VastraGotaland - 2022-00332-01
- Acronym
- STARCARE
- Status last verified
- Jul 2023
- First submitted
- 30 Jun 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Adolfsson P, Heringhaus A, Sjunnesson K, Mehkri L, Bolin K. Cost-effectiveness of the tandem t: Slim X2 with control-IQ technology automated insulin delivery system in children and adolescents with type 1 diabetes in Sweden. Diabet Med. 2024 Nov;41(11):e15432. doi: 10.1111/dme.15432. Epub 2024 Sep 6.
PubMed 39239975
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing Tandem Control-IQ With Real-time Continuous Glucose Monitoring (rtCGM) Used Together With Insulin Pens and Insulin Pumps for 18 Months
- ClinicalTrials.gov ID
- NCT05969106
- Acronym / sponsor ID
- STARCARE / VastraGotaland - 2022-00332-01
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 1 Aug 2023 (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.
To evaluate Tandem Control-IQ compared with rtCGM and insulin pen respectively rtCGM and insulin pump treatment in children and adolescents regarding glucose control, sleep and health economics for 18 months.
Detailed description
In this obesrvational study, the investigators assessed glycemic outcomes, sleep and health economics associated with AID treatment (Tandem Control-IQ) compared with multiple daily insulin injections with rtCGM (MDI+rtCGM) and a standalone insulin pump with rtCGM (CSII+rtCGM). Participants from two clinical sites in Sweden who continuously used one of the three modalities for at least six months were included in the analysis. Inclusion required all participants to use the Dexcom G6 rtCGM sensor for glucose monitoring, which meant only insulin treatment differentiated the three groups. Comparisons were conducted regarding Hemoglobon A1c (HbA1c) at the start of the study and rtCGM-generated glycemic metrics from 1 month before the study started until 18 months. Sleep quality and quantity were assessed using a questionnaire for the persons with diabetes and the caretakers. Indirect and direct costs in all healthcare systems and additional information on sick leaves were collected from the Swedish Social Insurance Agency. Comparisons were then made between the three treatment alternatives.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rtCGM + MDI | – | Device: Tandem Control-IQReal-time CGM Dexcom G6 used in parallel to Multiple Daily Injections (MDI) |
| rtCGM + CSII | – | Device: Tandem Control-IQReal-time CGM Dexcom G6 used in parallel to freestanding Continuous Subcutaneous Insulin Infusion (CSII) |
| Tandem Control-IQ | – | Device: Tandem Control-IQRealtime CGM Dexcom G6 used as part of the Automated Insulin Delivery (AID) system |
Who may qualify
- Ages
- 2 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Individuals diagnosed with Type 1 diabetes at two different pediatric diabetes centres.
Key inclusion criteria (4 listed)
- Age between 2-19 years at the start
- Diagnosed with Type 1 diabetes
- Min duration three months
- Willingness to participate in the study
Key exclusion criteria (5 listed)
- Pregnancy
- Unwillingness to share and upload CGM data
- Reluctance to come to visit and to follow protocol
- History of allergic reaction to Dexcom CGM materials or adhesives in contact with the skin.
- Abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo)
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 |
|---|---|---|
| Tandem Control-IQAID-system | Device | Tandem Control-IQ, rtCGM + CSII, rtCGM + MDI |
Primary outcome
Glycemic metrics
Time frame: Change from baseline to 6, 12 and 18 months
Time in range (TIR), Time below range (TBR) Level 1 and 2, Time above range (TAR) Level 1 and 2, Time in tighter range (TITR)
Sleep
Time frame: At study completion at 12 months.
Quantity and quality are defined in the questionnaire. Assessment by a 10-point Likert scale (1= "Worst possible", 10= "Best possible")
Costs - direct
Time frame: From baseline until study completion at 18 months
Cost for the insulin administration devices and continuous glucose monitoring devices per person/year (direct). All costa are calculated in Swedish currency (SEK).
Costs - indirect
Time frame: From baseline until study completion at 18 months
Cost for comorbidities and all health-care related costs (indirect), including societal costs based on days with sick-leaves (indirect). All costs are calculated in Swedish currency (SEK).
Quality Adjusted Life Year (QALY)
Time frame: From baseline until study completion at 18 months.
Quality Adjusted Life Year is estimated for each health state by literature search and for each of the three treatment alternatives. QALY is a generic measure of disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the value of medical interventions. One QALY equates to one year in perfect health. QALY scores range from 1 (perfect health) to 0 (dead). Thus, a higher value means a better outcome.
Cost/QALY
Time frame: From baseline until study completion at 18 months.
Cost/QALY is estimated for each health state by literature search and for each of the three treatment alternatives. Cost/QALY is illustrating the cost per disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the cost per value of medical interventions. A lower value means a better outcome.
Incremental Cost Efficiency Rate (ICER)
Time frame: From baseline until study completion at 18 months.
Based on glucose control cost-effect pairs is generated for Tandem Control-IQ vs. MDI respectively Tandem-Control-IQ vs. CSII. An ICER is calculated by dividing the difference in total costs (incremental cost) by the difference in the chosen measure of health outcome or effect (incremental effect) to provide a ratio of 'extra cost per extra unit of health effect' - for therapy A vs therapy B. A higher value means a better outcome. A prediction is added 10-, 20-, and 30-years ahead. ICER is estimated for these three time intervals.
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 1 Aug 2023.
- Derived from this study: PubMed 39239975Adolfsson P, Heringhaus A, Sjunnesson K, Mehkri L, Bolin K. Cost-effectiveness of the tandem t: Slim X2 with control-IQ technology automated insulin delivery system in children and adolescents with type 1 diabetes in Sweden. Diabet Med. 2024 Nov;41(11):e15432. doi: 10.1111/dme.15432. Epub 2024 Sep 6.
- 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.
Peter Adolfsson, MD PhD principal investigator
Västra Götalandsregionen, Gothenburg University
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, run by Vastra Gotaland Region at 1 site in Sweden.
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: finished, as of the sponsor's last update on 1 Aug 2023. 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 Sweden. 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?
Glycemic metrics (time frame: Change from baseline to 6, 12 and 18 months). The study lists 7 primary outcomes in all. 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 NCT05969106, which also lists 1 linked publication.
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 1 Aug 2023.