Diabetes Mellitus, Type 1QUESTNCT03103867
QUality of Control and slEep in Children With diabeteS, Using New Technology
A study testing CGM augmented pump with PLGS , and Insulin pump with CGM in people with Diabetes Mellitus, Type 1, run by Centre Hospitalier du Luxembourg at 1 site in Luxembourg.
Trial summary
The study is an open label single centre randomised cross over study to evaluate the impact of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin administration (640G® with the Smart Guard feature) versus the use of the same pump for insulin administration with 'only' continuous… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- CGM augmented pump with PLGS , and Insulin pump with CGM
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteLuxembourg
- Study dates
- 23 Feb 2017to 15 Jul 2018
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type 1 diabetes
- Duration of diabetes ≥ 6 months
- Insulin pump treatment ≥ 6 months
- HbA1c ≤ 11%
- Parental written informed consent
Who cannot join
- . No parental consent
- Physical or psychological disease likely to interfere with an appropriate conduct of the study
- Current drug therapy knowing to interfere with glucose metabolism
- Chronic sleep medication in the primary caregiver or the patient -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Two Different Glucose Monitoring Treatments and Their Impact on Time in Target, Sleep and Quality of Life in Children With Type 1 Diabetes and Primary Caregivers.
The study is an open label single centre randomised cross over study to evaluate the impact of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin administration (640G® with the Smart Guard feature) versus the use of the same pump for insulin administration with 'only' continuous glucose measurements (not interacting with the pump, Freestyle Libre ® ) on the time in glucose target , in hypo- and hyperglycemia. Exploratory endpoints are the effect on sleep and quality of life in children with type 1 diabetes and their caregivers.
Read the detailed description
Optimising metabolic control in children with Type 1Diabetes Mellitus (T1DM) is essential to prevent late complications. Fear of nocturnal hypoglycemia is pervasive amongst parents of children with T1DM, leading to a heightened vigilance by parents to control regularly their children's blood sugar values or to check the sensor information during the night. This leads to chronic sleep interruption and to lack of sleep as well in the parents as in their children with diabetes.
In this study, the impact of new technologies on glucose time in target , hypo fear and quality of life will be evaluated, using continuous interstitial glucose measurements either with a direct impact on insulin administration (640G medtronic pump (R)) and with alerts , or without impact on insulin administration and without alerts.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- CGM augmented pump with PLGS ,, Insulin pump with CGM
- 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.
CGM augmented pump with PLGS ,Device
Also called 640G, Enlite Sensors , Freestyle Libre
5 weeks treatment CGM augmented pump with PLGS compared with 5 weeks treatment with insulin pump with CGM , without integration
Insulin pump with CGMDevice
Also called 640G , freestyle libre
5 weeks treatment continuous subcutaneous insulin infusion pump with CGM without data integration,
| Study group | Role | What they receive |
|---|---|---|
| CGM augmented pump with PLGS (A) | Experimental | Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with integrated continuous glucose monitoring and predicted low glucose suspense (PLGS) Randomised cross over treatment during 5 weeks Receives: Device: CGM augmented pump with PLGS , |
| Insulin pump with CGM (B) | Active comparator | Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with second device measuring continuous glucose Randomised cross over treatment during 5 weeks Receives: Device: Insulin pump with CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in glucose target
Percent time in glucose target (3.9 -8 mmol/l) , measured by blinded CGM
Measured: Last 6 days of treatment arm A and last 6 days of treatment arm B
Secondary outcomes (5)
time below glucose target
Percent time spent below glucose target (<3.0mmol/l and < 2,5 mmol/l) measured by blinded CGM (I-Pro 2)
Measured: Last 6 days of treatment arm A and last 6 days of treatment arm B
Time above glucose target
Percent time spent above glucose target (>10.0mmol/l ) measured by blinded CGM (I-Pro 2)
Measured: Last 6 days of treatment arm A and last 6 days of treatment arm B
Sleep quantity in patients and caregivers
Total sleep and wake time , number of awakenings measured by wireless actigraph
Measured: baselines ( before treatment arm starts) and last week of treatment arm A and last week of treatment arm B
perception of quality of sleep and quality of life in patients and caregivers
validated questionnaires
Measured: baseline and last week of treatment arm A and last week of treatment arm B
hypoglycaemia fear in patients and caregivers
Hypoglycemia fear survey for parents and children
Measured: baseline and last week of treatment arm A and last week of treatment arm B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start23 Feb 2017
- Primary completion4 May 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier du Luxembourg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carine de Beaufort, Centre Hospitalier du Luxembourg
- Investigators
- Carine de Beaufort, MD,PhD, Study chair, Centre Hospitalier du Luxembourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103867
- Sponsor's protocol ID
- QUEST
- Acronym
- QUEST
- Status last verified
- Aug 2018
- First submitted
- 26 Mar 2017
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Schierloh U, Aguayo GA, Fichelle M, De Melo Dias C, Schritz A, Vaillant M, Barnard-Kelly K, Cohen O, Gies I, de Beaufort C. Fear of hypoglycemia and sleep in children with type 1 diabetes and their parents. Front Endocrinol (Lausanne). 2024 Dec 16;15:1419502. doi: 10.3389/fendo.2024.1419502. eCollection 2024.
PubMed 39736868Schierloh U, Aguayo GA, Schritz A, Fichelle M, De Melo Dias C, Vaillant MT, Cohen O, Gies I, de Beaufort C. Intermittent Scanning Glucose Monitoring or Predicted Low Suspend Pump Treatment: Does It Impact Time in Glucose Target and Treatment Preference? The QUEST Randomized Crossover Study. Front Endocrinol (Lausanne). 2022 May 31;13:870916. doi: 10.3389/fendo.2022.870916. eCollection 2022.
PubMed 35712259Schierloh U, Aguayo GA, Fichelle M, De Melo Dias C, Celebic A, Vaillant M, Barnard K, Cohen O, de Beaufort C. Effect of predicted low suspend pump treatment on improving glycaemic control and quality of sleep in children with type 1 diabetes and their caregivers: the QUEST randomized crossover study. Trials. 2018 Dec 4;19(1):665. doi: 10.1186/s13063-018-3034-4.
PubMed 30509293
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Different Glucose Monitoring Treatments and Their Impact on Time in Target, Sleep and Quality of Life in Children With Type 1 Diabetes and Primary Caregivers.
- ClinicalTrials.gov ID
- NCT03103867
- Acronym / sponsor ID
- QUEST / QUEST
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centre Hospitalier du LuxembourgUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 6 Apr 2017 (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 study is an open label single centre randomised cross over study to evaluate the impact of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin administration (640G® with the Smart Guard feature) versus the use of the same pump for insulin administration with 'only' continuous glucose measurements (not interacting with the pump, Freestyle Libre ® ) on the time in glucose target , in hypo- and hyperglycemia. Exploratory endpoints are the effect on sleep and quality of life in children with type 1 diabetes and their caregivers.
Detailed description
Optimising metabolic control in children with Type 1Diabetes Mellitus (T1DM) is essential to prevent late complications. Fear of nocturnal hypoglycemia is pervasive amongst parents of children with T1DM, leading to a heightened vigilance by parents to control regularly their children's blood sugar values or to check the sensor information during the night. This leads to chronic sleep interruption and to lack of sleep as well in the parents as in their children with diabetes.
In this study, the impact of new technologies on glucose time in target , hypo fear and quality of life will be evaluated, using continuous interstitial glucose measurements either with a direct impact on insulin administration (640G medtronic pump (R)) and with alerts , or without impact on insulin administration and without alerts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM augmented pump with PLGS (A) | Experimental | Device: CGM augmented pump with PLGS ,Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with integrated continuous glucose monitoring and predicted low glucose suspense (PLGS) Randomised cross over treatment during 5 weeks |
| Insulin pump with CGM (B) | Active comparator | Device: Insulin pump with CGMAdministration of Subcutaneous administration of Continuous subcutaneous insulin infusion with second device measuring continuous glucose Randomised cross over treatment during 5 weeks |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Type 1 diabetes
- Duration of diabetes ≥ 6 months
- Insulin pump treatment ≥ 6 months
- HbA1c ≤ 11%
- Parental written informed consent
Key exclusion criteria (4 listed)
- . No parental consent
- Physical or psychological disease likely to interfere with an appropriate conduct of the study
- Current drug therapy knowing to interfere with glucose metabolism
- Chronic sleep medication in the primary caregiver or the patient -
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 |
|---|---|---|
| CGM augmented pump with PLGS ,Also: 640G, Enlite Sensors , Freestyle Libre5 weeks treatment CGM augmented pump with PLGS compared with 5 weeks treatment with insulin pump with CGM , without integration | Device | CGM augmented pump with PLGS (A) |
| Insulin pump with CGMAlso: 640G , freestyle libre5 weeks treatment continuous subcutaneous insulin infusion pump with CGM without data integration, | Device | Insulin pump with CGM (B) |
Primary outcome
Time in glucose target
Time frame: Last 6 days of treatment arm A and last 6 days of treatment arm B
Percent time in glucose target (3.9 -8 mmol/l) , measured by blinded CGM
5 secondary outcomes
time below glucose target
Time frame: Last 6 days of treatment arm A and last 6 days of treatment arm B
Time above glucose target
Time frame: Last 6 days of treatment arm A and last 6 days of treatment arm B
Sleep quantity in patients and caregivers
Time frame: baselines ( before treatment arm starts) and last week of treatment arm A and last week of treatment arm B
perception of quality of sleep and quality of life in patients and caregivers
Time frame: baseline and last week of treatment arm A and last week of treatment arm B
hypoglycaemia fear in patients and caregivers
Time frame: baseline and last week of treatment arm A and last week of treatment arm B
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 3 Aug 2018.
- Derived from this study: PubMed 39736868Schierloh U, Aguayo GA, Fichelle M, De Melo Dias C, Schritz A, Vaillant M, Barnard-Kelly K, Cohen O, Gies I, de Beaufort C. Fear of hypoglycemia and sleep in children with type 1 diabetes and their parents. Front Endocrinol (Lausanne). 2024 Dec 16;15:1419502. doi: 10.3389/fendo.2024.1419502. eCollection 2024.
- Derived from this study: PubMed 35712259Schierloh U, Aguayo GA, Schritz A, Fichelle M, De Melo Dias C, Vaillant MT, Cohen O, Gies I, de Beaufort C. Intermittent Scanning Glucose Monitoring or Predicted Low Suspend Pump Treatment: Does It Impact Time in Glucose Target and Treatment Preference? The QUEST Randomized Crossover Study. Front Endocrinol (Lausanne). 2022 May 31;13:870916. doi: 10.3389/fendo.2022.870916. eCollection 2022.
- Derived from this study: PubMed 30509293Schierloh U, Aguayo GA, Fichelle M, De Melo Dias C, Celebic A, Vaillant M, Barnard K, Cohen O, de Beaufort C. Effect of predicted low suspend pump treatment on improving glycaemic control and quality of sleep in children with type 1 diabetes and their caregivers: the QUEST randomized crossover study. Trials. 2018 Dec 4;19(1):665. doi: 10.1186/s13063-018-3034-4.
- 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.
Carine de Beaufort, MD,PhD study chair
Centre Hospitalier du Luxembourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM augmented pump with PLGS , and Insulin pump with CGM in people with Diabetes Mellitus, Type 1, run by Centre Hospitalier du Luxembourg at 1 site in Luxembourg.
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 5 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 3 Aug 2018. 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 Luxembourg. 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 target (time frame: Last 6 days of treatment arm A and last 6 days of treatment arm B). 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 NCT03103867, which also lists 3 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 3 Aug 2018.