Study the Feasibility of Permanent Use of inControl for t... | NCT02892604

Studies
Study the Feasibility of Permanent Use of inControl for the Treatment of Type 1 Diabetes

NCT02892604

Sponsor

University Hospital, Montpellier

Status

Terminated

Last Update Posted

Dec 9, 2021Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Type 1 Diabetes

Interventions

insulin pump to inControl AP platform

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not enough participants

Expanded Access Info

Start Date

Nov 24, 2015Actual

Primary Completion Date

Jun 24, 2017Actual

Completion Date

Jun 24, 2017Actual

First Submitted Date

Sep 2, 2016

First Submission Date that Met QC Criteria

Sep 7, 2016

First Posted Date

Sep 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2021

Last Update Posted Date

Dec 9, 2021Actual

Name	Class
MEDBIOMED, Montpellier, France	UNKNOWN
Jaeb Center for Health Research	OTHER
University of Virginia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A new version of the DiAs artificial pancreas (AP) system has been developed in view of wide scale outpatient trials. Denominated as inControl , it includes improved user interface and communication modules while closed-loop algorithms remain similar. During this pilot study, the investigators will evaluate this new version of AP for a two-week period during which the patients will use it for closed-loop insulin delivery 24/7 The main goal is train the clinical team with the new system and collect patient opinions on system acceptance from questionnaires. If this trial is conclusive, a randomized 6-month multicentre study including 240 patients will be initiated. A total of 5 patients will be included in this training study over a 4-week period.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
insulin delivery driven by inControl	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin pump to inControl AP platform	Device	Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data.	insulin delivery driven by inControl

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent time of active insulin closed-loop delivery	Percent time while AP system is active permanently	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percent time with blood glucose in target range	Percent time while blood glucose is kept in safe 70-180 mg/dl range	2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 1 diabetes mellitus since more than one year, treated by insulin since at least one year
Treatment by insulin pump since at least 6 months
Glycated hemoglobin (HbA1c) below 10.5% at inclusion visit
For women of child bearing age, no current pregnancy and use of an efficient contraception during the whole research participation
Agreement on no use of drugs or products used for reduction of blood glucose levels, such as metformin or GLP1 analogs, except if this therapy has been used for at least 3 months before study start
Agreement on stopping closed-loop insulin delivery after acetaminophen use and 4 following hours
Agreement on suspending use of patient CGM device during the study period while study CGM will be used
Access to the internet and a mobile phone network at home
Agreement on following study procedures
Affiliation to the French social security system or a similar healthcare coverage system
Mandatory written informed consent

Exclusion Criteria:

Need for chronic use of acetaminophen
Start of use of drugs or products used for reduction of blood glucose levels, such as metformin or GLP1 analogs during the 3 months before inclusion
Hemophilia or other coagulation disorders
Psychological and/or cognitive troubles which may impair the appropriate following of study procedures
Diabetic ketoacidosis during the last 6 months
Acute cardiovascular event during the last 12 months
Severe hypoglycaemia with convulsions or loss of conscience during the last 12 months
Use of a therapy with significant impact on glucose metabolism
Cystic fibrosis
Lack of nearby third-party assistance availability in case of troubles
Malignant disease, except if considered as cured since at least 10 years
Impaired kidney function (serum creatinin > 150 umol/L)
Impaired liver status (ALAT or ASAT > 2-times upper normal limit)
Active gastroparesis
Acute adrenocortical event
Alcohol or narcotics abuse

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases