NCT02061488

Brief Summary

The purpose of the study is to assess a new closed-loop algorithm in type 1 diabetes (Saddle Point Model Predictive Control : SP-MPC)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

February 11, 2014

Last Update Submit

May 22, 2023

Conditions

Type 1 Diabetes

Keywords

Artificial pancreas, closed loop glucose control, model predictive control

Outcome Measures

Primary Outcomes (1)

  • Assessment of time spent in target range (glycemia between 70 and 145 mg/dl) and in hypoglycemia (glycemia <70 mg/dl), during the night (11 PM to 8 AM)

    Assessment of the ability of SP-MPC controler to maintain euglycemia and avoid hypoglycaemia during the night, compared to open loop in type 1 diabetic patients treated by insulin pump

    6 weeks

Secondary Outcomes (7)

  • Assessment of time spent above 70 mg/dl, between 70-145 or 145-180 mg/dl and above 180 mg/dl (interstitial glucose) in the late post prandial period (9 to 11 PM) and during the night (11 PM to 8 AM)

    6 weeks

  • Assessment of hypoglycemia occurrence during the night

    6 weeks

  • Assessment of area under the curves (70-180mg/dl) during the night

    6 weeks

  • Assessment of Low Blood Glucose Index (LBGI), High Blood Glucose Index (HBGI) and CONGA Index

    6 weeks

  • Assessment of insulin doses delivered between 9 PM and 8 AM

    6 weeks

  • +2 more secondary outcomes

Study Arms (2)

open-loop night

ACTIVE COMPARATOR
Other: open-loop night

closed-loop night

EXPERIMENTAL
Other: closed-loop night

Interventions

open-loop nightOTHER

During the open-loop night the patient is using his insulin pump as usual

open-loop night
closed-loop nightOTHER

During the closed-loop night glucose values measured by the sensor are collected every 15 minutes. The data are entered into the SP-MPC controler that calculate the insulin dose to be delivered. A diabetologist validates the insulin dose before the infusion (manually bolus infusion)

closed-loop night

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 1 diabetes (C peptide negative) :
  • to 70 year old,
  • with type 1 diabetes for more than 3 years,
  • treated by insulin pump for more than 3 months,
  • with previous CGM holter allowing preliminary settting of some of the SP-MPC parameters
  • able to provide written informed consent.

You may not qualify if:

  • pregnancy or breastfeeding,
  • severe non stabilized diabetic retinopathy,
  • cardiovascular event in the previous 6 months,
  • infectious diseases with recent fever,
  • anemia (hemoglobin \< 11g/l),
  • HbA1c \> 10%,
  • Current or recent (less than 4 weeks) oral or injectable corticosteroid treatment,
  • creatinine clearance \<40ml/mn,
  • chronic alcoholism (weekly consumption of alcohol \> 280g for men and \> 140g for women),
  • adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

Related Publications (1)

  • Guilhem I, Penet M, Paillard A, Carpentier M, Esvant A, Lefebvre MA, Poirier JY. Manual Closed-Loop Insulin Delivery Using a Saddle Point Model Predictive Control Algorithm: Results of a Crossover Randomized Overnight Study. J Diabetes Sci Technol. 2017 Sep;11(5):1007-1014. doi: 10.1177/1932296817717503. Epub 2017 Jul 5.

    PMID: 28677416RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Isabelle Guilhem

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 12, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations

FR(1)