Type 1 DiabetesTREAD-DIABNCT02824510
Evaluation of Glycemic Changes During Exercise in Children With Type 1 Diabetes
A study testing Algorithmic changes in insulin therapy., Treadmill exercises and Insulin aspart, glargine and detemir in people with Type 1 Diabetes, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The objectives of the study are: 1) to evaluate the effects of moderate exercise on SG evolution without insulin dose modification in patients with T1D under continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) therapy, and compare differences between these 2 groups; 2) to evaluate the… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Algorithmic changes in insulin therapy., Treadmill exercises and Insulin aspart, glargine and detemir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2014to Jan 2017
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of T1D (according to the ISPAD 2011 guidelines)
- T1D outside of partial remission phase (defined according to the IDAA1C definition [Diabetes Care 2007], being equal to A1C (%) + [4 x insulin dose (units per kilogram per 24 h)] and at least > 2 years after T1D diagnosis (defined as the first day of insulin therapy)
Who cannot join
- Non-type 1 diabetes
- Severe neonatal asphyxia (defined as Apgar score 3 or less after 5 min), children born small for gestational age, chronic systemic disease, active malignancy, hypothyroidism, hypopituitarism, developmental delay, bladder dysfunction, obesity, carnitine deficiency, β-oxidation defect, cardiac malformations, dysrhythmia
- Intake of drugs interfering with insulin sensitivity (e.g. corticosteroids, GH).
- HbA1C >9.5% at the time of enrollment in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Glycemic Changes and Optimization of Glycemic Control During Exercise in Children With Type 1 Diabetes Under Continuous Subcutaneous Insulin Infusion (CSII) or Multiple Daily Injection Regimen (MDI) (TREAD-DIAB Study)
The objectives of the study are: 1) to evaluate the effects of moderate exercise on SG evolution without insulin dose modification in patients with T1D under continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) therapy, and compare differences between these 2 groups; 2) to evaluate the impact of insulin dose modification (bolus, basal, reduction or increase, based on SG evolution profile obtained after first exercise) before and/or during moderate exercise on T1D children under CSII and MDI regimen, and compare differences between these 2 groups.
Read the detailed description
Intervention and procedures:
- The patients will first be assigned to standardized moderate-to-vigorous exercise for SG determination; b) similar exercise will then be repeated with preemptive adaptation of insulin dose (tailored on SG evolution during first exercise) for determination of potential influences on SG evolution.
Intervention Plan:
- At first visit (day [>18h] before exercise): setting of a Continuous Glucose Monitoring System
- At second visit: moderate-to-vigorous exercise with treadmill.
- At third visit (2 days after exercise): removal of CGMS
- At fourth visit (day [>18h] before fifth visit): setting of a Continuous Glucose Monitoring System
- At fifth visit: moderate exercise with treadmill, and insulin dose modification (basal rate, bolus, reduction, increase)
- At sixth visit (2 days after exercise): removal of CGMS
- Total number of visits: 6
- The exercises will be performed between 1 and 2 hours after breakfast or after lunch; the second exercise will be performed ≥2 weeks after the first exercise.
Controls:
- Moderate exercise with and without modification of insulin dose in MDI patients (by comparison with CSII patients). MDI patients will be matched to CSII patients according to gender, age, BMI (±0.5 z-score) and HbA1C levels (±1%) to exclude any bias in patient allocation.
- Moderate exercise without modification of insulin dose at first visit (by comparison with modification of insulin dose).
- Conditions
- Type 1 Diabetes
- Being tested
- Algorithmic changes in insulin therapy., Treadmill exercises, Insulin aspart, glargine and detemir
- 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.
Algorithmic changes in insulin therapy.Other
Based on SG evolution in first treadmill test, algorithms will evaluate the modifications in insulin therapy required to normalize SG during the second treadmill test.
Treadmill exercisesOther
25 min treadmill exercise at 60% of maximal heart rate estimated for age
Insulin aspart, glargine and detemirDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients under insulin pump therapy. | Active comparator | Patients under insulin pump therapy. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart). Receives: Other: Algorithmic changes in insulin therapy.; Other: Treadmill exercises; Drug: Insulin aspart, glargine and detemir |
| Patients under MDI. | Active comparator | Patients under multiple daily injection regimen. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart and glargine or detemir). Receives: Other: Algorithmic changes in insulin therapy.; Other: Treadmill exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subcutaneous glucose evolution
Subcutaneous glucose evolution after completion of 2 exercise tests
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startAug 2014
- Primary completionSep 2016
- Study completionJan 2017
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 Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe A Lysy, MD PhD, Principal investigator, Cliniques Universitaires Saint Luc, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824510
- Sponsor's protocol ID
- 2013/18NOV/510
- Acronym
- TREAD-DIAB
- Status last verified
- Sep 2019
- First submitted
- 29 Jun 2016
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Moniotte S, Owen M, Barrea T, Robert A, Lysy PA. Outcomes of algorithm-based modifications of insulinotherapy during exercise in MDI vs insulin pump-treated children with type 1 diabetes: Results from the TREAD-DIAB study. Pediatr Diabetes. 2017 Dec;18(8):925-933. doi: 10.1111/pedi.12509. Epub 2017 Mar 2.
PubMed 28251726
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Glycemic Changes and Optimization of Glycemic Control During Exercise in Children With Type 1 Diabetes Under Continuous Subcutaneous Insulin Infusion (CSII) or Multiple Daily Injection Regimen (MDI) (TREAD-DIAB Study)
- ClinicalTrials.gov ID
- NCT02824510
- Acronym / sponsor ID
- TREAD-DIAB / 2013/18NOV/510
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 6 Jul 2016 (estimated)
- 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 objectives of the study are: 1) to evaluate the effects of moderate exercise on SG evolution without insulin dose modification in patients with T1D under continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) therapy, and compare differences between these 2 groups; 2) to evaluate the impact of insulin dose modification (bolus, basal, reduction or increase, based on SG evolution profile obtained after first exercise) before and/or during moderate exercise on T1D children under CSII and MDI regimen, and compare differences between these 2 groups.
Detailed description
Intervention and procedures:
- The patients will first be assigned to standardized moderate-to-vigorous exercise for SG determination; b) similar exercise will then be repeated with preemptive adaptation of insulin dose (tailored on SG evolution during first exercise) for determination of potential influences on SG evolution.
Intervention Plan:
- At first visit (day [>18h] before exercise): setting of a Continuous Glucose Monitoring System
- At second visit: moderate-to-vigorous exercise with treadmill.
- At third visit (2 days after exercise): removal of CGMS
- At fourth visit (day [>18h] before fifth visit): setting of a Continuous Glucose Monitoring System
- At fifth visit: moderate exercise with treadmill, and insulin dose modification (basal rate, bolus, reduction, increase)
- At sixth visit (2 days after exercise): removal of CGMS
- Total number of visits: 6
- The exercises will be performed between 1 and 2 hours after breakfast or after lunch; the second exercise will be performed ≥2 weeks after the first exercise.
Controls:
- Moderate exercise with and without modification of insulin dose in MDI patients (by comparison with CSII patients). MDI patients will be matched to CSII patients according to gender, age, BMI (±0.5 z-score) and HbA1C levels (±1%) to exclude any bias in patient allocation.
- Moderate exercise without modification of insulin dose at first visit (by comparison with modification of insulin dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients under insulin pump therapy. | Active comparator | Other: Algorithmic changes in insulin therapy., Other: Treadmill exercises, Drug: Insulin aspart, glargine and detemirPatients under insulin pump therapy. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart). |
| Patients under MDI. | Active comparator | Other: Algorithmic changes in insulin therapy., Other: Treadmill exercisesPatients under multiple daily injection regimen. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart and glargine or detemir). |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of T1D (according to the ISPAD 2011 guidelines)
- T1D outside of partial remission phase (defined according to the IDAA1C definition [Diabetes Care 2007], being equal to A1C (%) + [4 x insulin dose (units per kilogram per 24 h)] and at least > 2 years after T1D diagnosis (defined as the first day of insulin therapy)
Key exclusion criteria (4 listed)
- Non-type 1 diabetes
- Severe neonatal asphyxia (defined as Apgar score 3 or less after 5 min), children born small for gestational age, chronic systemic disease, active malignancy, hypothyroidism, hypopituitarism, developmental delay, bladder dysfunction, obesity, carnitine deficiency, β-oxidation defect, cardiac malformations, dysrhythmia
- Intake of drugs interfering with insulin sensitivity (e.g. corticosteroids, GH).
- HbA1C >9.5% at the time of enrollment in the study.
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 |
|---|---|---|
| Algorithmic changes in insulin therapy.Based on SG evolution in first treadmill test, algorithms will evaluate the modifications in insulin therapy required to normalize SG during the second treadmill test. | Other | Patients under MDI., Patients under insulin pump therapy. |
| Treadmill exercises25 min treadmill exercise at 60% of maximal heart rate estimated for age | Other | Patients under MDI., Patients under insulin pump therapy. |
| Insulin aspart, glargine and detemir | Drug | Patients under insulin pump therapy. |
Primary outcome
Subcutaneous glucose evolution
Time frame: 12 months
Subcutaneous glucose evolution after completion of 2 exercise tests
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 Oct 2019.
- Results publication: PubMed 28251726Moniotte S, Owen M, Barrea T, Robert A, Lysy PA. Outcomes of algorithm-based modifications of insulinotherapy during exercise in MDI vs insulin pump-treated children with type 1 diabetes: Results from the TREAD-DIAB study. Pediatr Diabetes. 2017 Dec;18(8):925-933. doi: 10.1111/pedi.12509. Epub 2017 Mar 2.
- Individual participant dataSharing planned: Undecided
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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.
Philippe A Lysy, MD PhD principal investigator
Cliniques Universitaires Saint Luc, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithmic changes in insulin therapy., Treadmill exercises and Insulin aspart, glargine and detemir in people with Type 1 Diabetes, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 4 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 Oct 2019. 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 Belgium. 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?
Subcutaneous glucose evolution (time frame: 12 months). 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 NCT02824510, 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 Oct 2019.