Study the Feasibility of Permanent Use of inControl for the Treatment of Type 1 Diabetes (IDCLTraining)
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|ClinicalTrials.gov Identifier: NCT02892604|
Recruitment Status : Unknown
Verified November 2016 by University Hospital, Montpellier.
Recruitment status was: Recruiting
First Posted : September 8, 2016
Last Update Posted : November 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Device: insulin pump to inControl AP platform||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Evaluation Study of the Feasibility of a Permanent Use in Free-life of inControl Artificial Pancreas System for the Treatment of Type 1 Diabetes|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||July 2017|
Experimental: insulin delivery driven by inControl
Closed-loop insulin delivery using inControl AP system is assessed for two weeks, 24/7.
Connection of continuous glucose monitoring (CGM) system and insulin pump to inControl AP platform, all wireless and wearable, in free-life conditions Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data.
Device: insulin pump to inControl AP platform
Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data.
- Percent time of active insulin closed-loop delivery [ Time Frame: 2 weeks ]Percent time while AP system is active permanently
- Percent time with blood glucose in target range [ Time Frame: 2 weeks ]Percent time while blood glucose is kept in safe 70-180 mg/dl range
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892604
|Contact: Eric M RENARD, MD, PhD||467338382 ext email@example.com|
|Montpellier, France, 34295|
|Contact: Eric RENARD, MD PhD 467338382 ext 0033 firstname.lastname@example.org|
|Study Director:||Eric M RENARD, MD, PhD||University Hospital, Montpellier|