- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509429
Comparison of an Artificial Pancreas Versus Threshold Low Glucose Suspend in Type 1 Diabetic Children (SHAN)
June 12, 2018 updated by: University Hospital, Montpellier
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Angers, France, 49000
- CHU d'Angers
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Montpellier, France, 34985
- CHU Montpellier - Hôpital Lapeyronie
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Paris, France, 75019
- AP-HP, Hôpital Robert Debré
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Tours, France, 37000
- CHU de Tours, Hôpital Clocheville
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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 €
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control-to-Range algorithm and Threshold Low Glucose Suspend
On this arm, patients will realize two investigational sessions:
|
The insuline used is usual patient insuline.
There is no specific insulin for this protocol
The insuline used is usual patient insuline.
There is no specific insulin for this protocol
|
Experimental: Threshold Low Glucose Suspend and Control-to-Range algorithm
On this arm, patients will realize two investigational sessions:
|
The insuline used is usual patient insuline.
There is no specific insulin for this protocol
The insuline used is usual patient insuline.
There is no specific insulin for this protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time spent with blood glucose <70 mg/dl
Time Frame: from 22:00 to 08:00, over two consecutive nights
|
from 22:00 to 08:00, over two consecutive nights
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent time spent with blood glucose <70mg/dl
Time Frame: over two consecutive days (48h)
|
over two consecutive days (48h)
|
Percent time spent with blood glucose level in 70-180 mg/dl range
Time Frame: from 22:00 to 08:00 over two consecutive nights
|
from 22:00 to 08:00 over two consecutive nights
|
Percent time spent with blood glucose level in 80-150 mg/dl range
Time Frame: from 22:00 to 08:00 over two consecutive nights
|
from 22:00 to 08:00 over two consecutive nights
|
Percent time spent with blood glucose level in 70-180 mg/dl range
Time Frame: over two consecutive days (48h)
|
over two consecutive days (48h)
|
Mean blood glucose level
Time Frame: from 22:00 to 08:00, over two consecutive nights
|
from 22:00 to 08:00, over two consecutive nights
|
Mean blood glucose level
Time Frame: over two consecutive days (48h)
|
over two consecutive days (48h)
|
Number of needed interventions by the patients, the parents, and by the investigational team, to treat hypoglycemia
Time Frame: during 65 hours of each investigational session
|
during 65 hours of each investigational session
|
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
Time Frame: during 65 hours of each investigational session
|
during 65 hours of each investigational session
|
Score of the Artificial Pancreas Acceptance Questionnaire
Time Frame: at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
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at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
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Score of the Hypo Fear Survey
Time Frame: at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
|
at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 16, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
July 8, 2015
First Submitted That Met QC Criteria
July 23, 2015
First Posted (Estimate)
July 28, 2015
Study Record Updates
Last Update Posted (Actual)
June 14, 2018
Last Update Submitted That Met QC Criteria
June 12, 2018
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Insulin, Long-Acting
- Insulin degludec, insulin aspart drug combination
- Insulin Lispro
Other Study ID Numbers
- 9525 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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