Adolescence and Diabetes:Can an Automated Closed Loop System Improve Control ?

NCT03300934 | Completed

• 1 other identifier: Spidiman
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the use of the FD2 automated closed loop insulin administration in Adolescents with a poor metabolic control . All youth will be treated in a random order by their usual pump treatment or an Automated system and we will evaluate whether this has an impact on metabolic control and sleep

Conditions

Type1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Time spent in glucose target (%) (3.9 - 10 mmol/l)

  Continuous blinded glucose monitoring during the study period with and without the automated Closed loop on a between arm comparison.

  4 week treatment arms

Secondary Outcomes (9)

• Time spent below glucose target (%) (<3.0mmol/l and < 2,5 mmol/l)

  4 week treatment arms

• Time spent above glucose target (%) (> 10 mmol/l)

  4 week treatment arms

• Severe hypoglycaemic events

  4 week treatment arms

• Severe Diabetes ketoacidosis

  4 week treatment arms

• Use of the automated closed loop system (% time)

  4 week treatment arm

Study Arms (2)

closed loop glucose control system

EXPERIMENTAL

Closed loop glucose control system

Device: closed loop glucose control system

CSII Pump treatment

NO INTERVENTION

CSII Pump treatment without the integrated algorithm and glucose sensor

Interventions

closed loop glucose control system DEVICE

Cross over between Closed loop glucose system with DANA pump, Navigator II CGM and Cambridge AP algorithm FD2A, versus usual CSII pump treatment

closed loop glucose control system

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years Type 1 diabetes according to WHO/ISPAD , for at least 1 year CSII treatment for at least 6 month HbA1c ≥ 8,0%, for more than 6 months Informed consent of the patient and parents

You may not qualify if:

• Non-type 1 diabetes mellitus including those secondary to chronic disease Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.
• Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator Known or suspected allergy against insulin Recurrent incidents of severe hypoglycaemia as defined by ISPAD guidelines during the previous 12 months.
• More than one episode of diabetic ketoacidosis (DKA) as defined by ISPAD in preceding 12 months

Sponsors & Collaborators

• Centre Hospitalier du Luxembourg: lead
• University of Cambridge: collaborator
• Luxembourg Institute of Health: collaborator

Study Sites (1)

Clinique des Enfants CHluxembourg

Luxembourg, 1210, Luxembourg

Location

Study Officials

• Carine de Beaufort, MD PhD

  Centre Hospitalier du Luxembourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guest professor

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 4, 2017
• Study Start: July 1, 2017
• Primary Completion: July 19, 2018
• Study Completion: July 19, 2018
• Last Updated: July 31, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1)