Type 1 DiabetesNCT04741685
Clinical Efectivity of Two Different Sensor-augmented Pumps With Low Predictive Suspension Function
An observational study of Type 1 Diabetes, run by Castilla-La Mancha Health Service at 3 sites in Spain.
Trial summary
Observational cross-sectional multicenter study about effectiveness of two different sensor augmented-pumps with low glucose predictive function in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- TTSX2 and MM640G
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 3 sitesSpain
- Study dates
- 15 Feb 2021to 10 Jun 2021
- How long will I take part?
- 3 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 1 diabetes adult patients treated with sensor-augmented pump (TTSX2 or MM640G)
Who may be able to join
- Type 1 diabetes
- Treated with TTSX2 or MM640.
Who cannot join
- Other kind of diabetes.
- Serious mental disease.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Badajoz University Hospital
Badajoz, 06080
Obispo Rafael Torija, St.
Ciudad Real, 13005
Nuestra Señora de la Candelaria University Hospital
Santa Cruz de Tenerife, Santa Cruz De Tenerife, 38010
About this study
Observational cross-sectional multicenter study about effectiveness of two different sensor augmented-pumps with low glucose predictive function in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice.
Read the detailed description
Cross-sectional multicenter analysis about clinical effectiveness of two different sensor-augmented pumps, Tandem T Slim X2 with Basal IQ (TTSX2) and Medtronic Minimed 640G with Smartguard (MM640G) in adult patients with type 1 Diabetes mellitus.
All clinical variables are gathered from three EMR softwares and two sensor-augmented pumps sotwares.
Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A Kruskal-Wallis or a Friedman test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A "P" value < 0.05 was considered statistically significant.
The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.
- Conditions
- Type 1 Diabetes
- Being tested
- TTSX2, MM640G
- 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.
TTSX2Device
Treatment with Tandem T Slim X2 with Basal IQ
MM640GDevice
Treatment with Medtronic Minimed 640G with Smartguard
| Study group | Role | What they receive |
|---|---|---|
| SAP with LGS | Type 1 diabetes adults patients treated with sensor-augmented insulin pump with low glucose predictive suspension function Receives: Device: TTSX2; Device: MM640G |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIR
time in range (TIR, 70-180 mg/dL, 3.9-10 mmol/L) of the interstitial glucose
Measured: during the procedure
Secondary outcomes (9)
TBR
time below range (TBR, <70 mg/dL, <3.9 mmol/L) of the interstitial glucose
Measured: during the procedure
TAR
time above range (TIR, 70-180 mg/dL, 3.9-10 mmol/L) of the interstitial glucose
Measured: during the procedure
HbA1C
Glycate haemoglobina A1C
Measured: during the procedure
GMI
Glucose management index
Measured: during the procedure
MAGE
Mean amplitude glucose excursions
Measured: during the procedure
%CV
Coefficient of variation percentage of the intersticial glucose
Measured: 14 days
DQOL
Diabetes quality of life (EsDQOL questionnary score), 43 questions, each question with a score from 1 to 5, worse score is five points.
Measured: during the procedure
Hypoglycemia perception 1
Hypoglycemia unawareness (Clarke questionnary score), 8 questions, each one score "R" or "not R", more "R" means worse score.
Measured: during the procedure
Hypoglycemia perception 2
Hypoglycemia unawareness (Gold questionnary scores), single question, score from 0 to 5, worse score is five points.
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start15 Feb 2021
- Primary completion1 Jun 2021
- Study completion10 Jun 2021
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.
- 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
- Cross-sectional
- Enrolment
- 23 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Castilla-La Mancha Health Service
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesús Moreno Fernández, Castilla-La Mancha Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741685
- Sponsor's protocol ID
- C-380
- Status last verified
- Jun 2021
- First submitted
- 29 Jan 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: All clinical data if requested.
Publications
Moreno-Fernandez J, Beato-Vibora P, Olvera P, Garcia-Seco JA, Gallego-Gamero F, Herrera MT, Munoz-Rodriguez JR. Real-world outcomes of two different sensor-augmented insulin pumps with predictive low glucose suspend function in type 1 diabetes patients. Diabetes Res Clin Pract. 2021 Nov;181:109093. doi: 10.1016/j.diabres.2021.109093. Epub 2021 Oct 13.
PubMed 34653567
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efectivity of Two Different Sensor-augmented Pumps With Low Predictive Suspension Function
- ClinicalTrials.gov ID
- NCT04741685
- Acronym / sponsor ID
- C-380
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Castilla-La Mancha Health ServiceUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 5 Feb 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.
Observational cross-sectional multicenter study about effectiveness of two different sensor augmented-pumps with low glucose predictive function in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice.
Detailed description
Cross-sectional multicenter analysis about clinical effectiveness of two different sensor-augmented pumps, Tandem T Slim X2 with Basal IQ (TTSX2) and Medtronic Minimed 640G with Smartguard (MM640G) in adult patients with type 1 Diabetes mellitus.
All clinical variables are gathered from three EMR softwares and two sensor-augmented pumps sotwares.
Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A Kruskal-Wallis or a Friedman test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A "P" value < 0.05 was considered statistically significant.
The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAP with LGS | – | Device: TTSX2, Device: MM640GType 1 diabetes adults patients treated with sensor-augmented insulin pump with low glucose predictive suspension function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 1 diabetes adult patients treated with sensor-augmented pump (TTSX2 or MM640G)
Key inclusion criteria (2 listed)
- Type 1 diabetes
- Treated with TTSX2 or MM640.
Key exclusion criteria (2 listed)
- Other kind of diabetes.
- Serious mental disease.
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 |
|---|---|---|
| TTSX2Treatment with Tandem T Slim X2 with Basal IQ | Device | SAP with LGS |
| MM640GTreatment with Medtronic Minimed 640G with Smartguard | Device | SAP with LGS |
Primary outcome
TIR
Time frame: during the procedure
time in range (TIR, 70-180 mg/dL, 3.9-10 mmol/L) of the interstitial glucose
9 secondary outcomes
TBR
Time frame: during the procedure
TAR
Time frame: during the procedure
HbA1C
Time frame: during the procedure
GMI
Time frame: during the procedure
MAGE
Time frame: during the procedure
%CV
Time frame: 14 days
DQOL
Time frame: during the procedure
Hypoglycemia perception 1
Time frame: during the procedure
Hypoglycemia perception 2
Time frame: during the procedure
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 11 Jun 2021.
- Derived from this study: PubMed 34653567Moreno-Fernandez J, Beato-Vibora P, Olvera P, Garcia-Seco JA, Gallego-Gamero F, Herrera MT, Munoz-Rodriguez JR. Real-world outcomes of two different sensor-augmented insulin pumps with predictive low glucose suspend function in type 1 diabetes patients. Diabetes Res Clin Pract. 2021 Nov;181:109093. doi: 10.1016/j.diabres.2021.109093. Epub 2021 Oct 13.
- Individual participant dataSharing planned: Undecided. All clinical data if requested.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 Castilla-La Mancha Health Service at 3 sites in Spain.
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 2 inclusion and 2 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 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
TIR (time frame: during the procedure). 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 NCT04741685, 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 11 Jun 2021.