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Type 1 DiabetesPhase 2SHANNCT02509429

Comparison of an Artificial Pancreas Versus Threshold Low Glucose Suspend in Type 1 Diabetic Children

A Phase 2 study testing Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend in people with Type 1 Diabetes, run by University Hospital, Montpellier at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to assess the efficacy of an Artificial Pancreas system which includes a Control-To-Range algorithm, versus standard Insulin Pump Therapy with Threshold Low glucose Suspend feature. 24 Children aged from 7 to 12 will be recruted in 4 clinical centres. Read more about this study

Who is it for?
Ages 7 to 12 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
4 sitesFrance
Study dates
16 Jun 2015to Dec 2016
Phase
Phase 2
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 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age from 7 to 12
  • Puberty status at Prader 1
  • Diabetes diagnosed according to WHO criteria since more than 1 year
  • Fasting plasma C-peptide level <0.2 ng/ml for a fasting blood glucose level < 180 mg/dl
  • At least one positiveness for plasma antibodies against pancreatic islets: IAA, IA2, GAD, ICA or ZnT8, since diagnosis of diabetes
  • Treatment of diabetes by insulin pump since more than 6 months
Show all 12Show fewer
  • HbA1c level below 8.5%
  • Trained in carbohydrate counting
  • Lack of any associated disease or therapy (except insulin) affecting glucose metabolism
  • Willingness to follow all study procedures
  • Informed consent signed by patient and parent or legally responsible party
  • Patient must be affiliated or beneficiary of a social medical insurance

Who cannot join

  • Unwillingness of one parent or the legally responsible party to be present during all study procedures
  • Expected use of acetaminophen-containing drugs
  • Any disease or therapy (except insulin) affecting glucose metabolism during previous month
  • Impaired cognitive or psychological abilities which may result in defective adherence to study procedures
  • Active enrollment in another clinical trial or participation in a study within 30 days or participation in previous studies resulting in a cumulated annual income which would exceed 4500 €

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • CHU d'Angers

    Angers, 49000

  • CHU Montpellier - Hôpital Lapeyronie

    Montpellier, 34985

  • AP-HP, Hôpital Robert Debré

    Paris, 75019

  • CHU de Tours, Hôpital Clocheville

    Tours, 37000

Other trials in France

About this study

Official title: Assessment of the Efficacy on the Reduction of Nocturnal Hypoglycemia in Children With Type 1 Diabetes of a Closed-loop Insulin Therapy (Artificial Pancreas) Compared to Insulin Pump Therapy Combined With Continuous Glucose Monitoring With Threshold Low Glucose Suspend of Infusion in Home-like Conditions

The objective of this study is to assess the efficacy of an Artificial Pancreas system which includes a Control-To-Range algorithm, versus standard Insulin Pump Therapy with Threshold Low glucose Suspend feature. 24 Children aged from 7 to 12 will be recruted in 4 clinical centres. After a 2 week run-in period, they will attend two investigational sessions of 65 hours in home-like settings. During each session, the CTR algorithm or the TLGS feature will be activated, depending on the randomization. The main endpoint is the time spent below 70mg/dL between 22:00 and 07:00.

Read the detailed description

The study is an open randomized control trial preceded by a run-in period and follows a cross-over design.After inclusion, the therapy will be moved to sensor augmented pump therapy with a dedicated training to continuous glucose monitoring using study system (study CGM). During 2 to 3 weeks, the patient will use his/her usual insulin pump and the study CGM (run-in period). At the end of this period, the patient and the relative will be admitted in a parents'house or hotel/resort nearby the hospital for 65 hours to undergo the first interventional session. Admission will be at 17:00 Day 1. The investigator will connect wirelessly the study pump and CGM to the study platform DiAs and remote monitoring will be activated. Until 08:00 Day 2, insulin delivery will be managed in open-loop mode, i.e. insulin doses will be decided according to capillary glucose measurements. From 08:00 Day 2, one algorithm will be activated according to the randomization order, i.e. either the threshold low glucose suspend (TLGS) algorithm (threshold will be set at 70 mg/dl) or the closed-loop algorithm. Insulin delivery will then be managed in open-loop mode with activated TLGS or by the closed-loop algorithm until 08:00 Day 4. In both cases, meals will be of free content and taken around 09:00, 13:00, 17:00 and 20:00. Meal insulin doses will be managed according to pre-meal glucose level and CHO meal content in open-loop mode with TLGS, or according to DiAs bolus calculator suggestion in closed-loop mode. Patient and relative will be encouraged to move in parents'house or hotel/resort and surroundings between meals. The algorithm will be inactivated at 08:00 Day 4. The study pump will be removed and replaced by patient's usual pump. The patient and the relative will be released at 10:00 after breakfast. Study CGM will still be used at home for 2 to 4 weeks until the second interventional session. This session will be similar to the first one but the alternative algorithm will be activated. Patient will come back to pre-study insulin therapy from 08:00 Day 4 and be released at 10:00 when second session is completed.

Conditions
Type 1 Diabetes
Being tested
Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm, Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend
Keywords
T1DM, Type 1 Diabetes, Artificial Pancreas, DiAs platform
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 therapy (aspart, lispro ou glulisine) with Control-to-Range algorithmDevice

    The insuline used is usual patient insuline. There is no specific insulin for this protocol

  • Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose SuspendDevice

    The insuline used is usual patient insuline. There is no specific insulin for this protocol

Study groups in NCT02509429
Study groupRoleWhat they receive
Control-to-Range algorithm and Threshold Low Glucose SuspendExperimentalOn this arm, patients will realize two investigational sessions: * the first with Control-to-Range algorithm (CTR), * the second with Threshold Low Glucose Suspend (TLGS).
Receives: Device: Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm; Device: Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend
Threshold Low Glucose Suspend and Control-to-Range algorithmExperimentalOn this arm, patients will realize two investigational sessions: * the first with Threshold Low Glucose Suspend (TLGS), * the second with Control-to-Range algorithm (CTR).
Receives: Device: Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm; Device: Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time spent with blood glucose <70 mg/dl

    Measured: from 22:00 to 08:00, over two consecutive nights

Secondary outcomes (10)

  1. Percent time spent with blood glucose <70mg/dl

    Measured: over two consecutive days (48h)

  2. Percent time spent with blood glucose level in 70-180 mg/dl range

    Measured: from 22:00 to 08:00 over two consecutive nights

  3. Percent time spent with blood glucose level in 80-150 mg/dl range

    Measured: from 22:00 to 08:00 over two consecutive nights

  4. Percent time spent with blood glucose level in 70-180 mg/dl range

    Measured: over two consecutive days (48h)

  5. Mean blood glucose level

    Measured: from 22:00 to 08:00, over two consecutive nights

  6. Mean blood glucose level

    Measured: over two consecutive days (48h)

  7. Number of needed interventions by the patients, the parents, and by the investigational team, to treat hypoglycemia

    Measured: during 65 hours of each investigational session

  8. Number of needed interventions by the patients, the parents, and by the investigational team, to fix issues related to the functioning of the insulin delivery system

    Measured: during 65 hours of each investigational session

  9. Score of the Artificial Pancreas Acceptance Questionnaire

    Measured: at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)

  10. Score of the Hypo Fear Survey

    Measured: at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2015 (estimated)
  2. Study start16 Jun 2015
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02509429
Sponsor's protocol ID
9525
Acronym
SHAN
Status last verified
Jul 2015
First submitted
8 Jul 2015
Last updated
14 Jun 2018
Results posted
No
Data monitoring committee
No

Publications

  • Renard E, Tubiana-Rufi N, Bonnemaison-Gilbert E, Coutant R, Dalla-Vale F, Farret A, Poidvin A, Bouhours-Nouet N, Abettan C, Storey-London C, Donzeau A, Place J, Breton MD. Closed-loop driven by control-to-range algorithm outperforms threshold-low-glucose-suspend insulin delivery on glucose control albeit not on nocturnal hypoglycaemia in prepubertal patients with type 1 diabetes in a supervised hotel setting. Diabetes Obes Metab. 2019 Jan;21(1):183-187. doi: 10.1111/dom.13482. Epub 2018 Aug 21.

    PubMed 30047223

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend in people with Type 1 Diabetes, run by University Hospital, Montpellier at 4 sites in France.

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 12 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 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 spent with blood glucose <70 mg/dl (time frame: from 22:00 to 08:00, over two consecutive nights). 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 NCT02509429, 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 14 Jun 2018.

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