A Phase 2 interventional study of Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm and Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend in Type 1 Diabetes, sponsored by University Hospital, Montpellier. Completed at 4 sites in France. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2018-06-14.
Sponsored by University Hospital, Montpellier · Phase 2, Interventional, and Treatment
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.
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 24 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
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Exclusion Criteria:
On this arm, patients will realize two investigational sessions: * the first with Control-to-Range algorithm (CTR), * the second with Threshold Low Glucose Suspend (TLGS).
Device: Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm · Device: Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend
On this arm, patients will realize two investigational sessions: * the first with Threshold Low Glucose Suspend (TLGS), * the second with Control-to-Range algorithm (CTR).
Device: Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm · Device: Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend
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
Time spent with blood glucose <70 mg/dl
Time frame: from 22:00 to 08:00, over two consecutive nights
Percent time spent with blood glucose <70mg/dl
Time frame: 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
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
Percent time spent with blood glucose level in 70-180 mg/dl range
Time frame: over two consecutive days (48h)
Mean blood glucose level
Time frame: from 22:00 to 08:00, over two consecutive nights
Mean blood glucose level
Time frame: 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
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
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)
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)
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier