Comparison of an Artificial Pancreas Versus Threshold Low Glucose Suspend in Type 1 Diabetic Children
SHAN
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
1 other identifier
interventional
24
1 country
4
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2015
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 16, 2015
CompletedFirst Submitted
Initial submission to the registry
July 8, 2015
CompletedFirst Posted
Study publicly available on registry
July 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 14, 2018
July 1, 2015
1.5 years
July 8, 2015
June 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time spent with blood glucose <70 mg/dl
from 22:00 to 08:00, over two consecutive nights
Secondary Outcomes (10)
Percent time spent with blood glucose <70mg/dl
over two consecutive days (48h)
Percent time spent with blood glucose level in 70-180 mg/dl range
from 22:00 to 08:00 over two consecutive nights
Percent time spent with blood glucose level in 80-150 mg/dl range
from 22:00 to 08:00 over two consecutive nights
Percent time spent with blood glucose level in 70-180 mg/dl range
over two consecutive days (48h)
Mean blood glucose level
from 22:00 to 08:00, over two consecutive nights
- +5 more secondary outcomes
Study Arms (2)
Control-to-Range algorithm and Threshold Low Glucose Suspend
EXPERIMENTALOn this arm, patients will realize two investigational sessions: * the first with Control-to-Range algorithm (CTR), * the second with Threshold Low Glucose Suspend (TLGS).
Threshold Low Glucose Suspend and Control-to-Range algorithm
EXPERIMENTALOn this arm, patients will realize two investigational sessions: * the first with Threshold Low Glucose Suspend (TLGS), * the second with Control-to-Range algorithm (CTR).
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 €
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU d'Angers
Angers, 49000, France
CHU Montpellier - Hôpital Lapeyronie
Montpellier, 34985, France
AP-HP, Hôpital Robert Debré
Paris, 75019, France
CHU de Tours, Hôpital Clocheville
Tours, 37000, France
Related Publications (1)
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.
PMID: 30047223DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2015
First Posted
July 28, 2015
Study Start
June 16, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
June 14, 2018
Record last verified: 2015-07