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Completed

NCT Number: NCT02061488

Assessment of a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC) (PPA)

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rennes University Hospital

Rennes, 35033, France

About this study

Ten patients will be assessed during a closed-loop night and an open-loop night in random order.

The primary objective is to assess 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with type 1 diabetes (C peptide negative) :
  • 18 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.

Exclusion criteria

  • 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

Treatment and study plan

open-loop night

Other

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

closed-loop night

Other

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)

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)

    Time frame: 6 weeks

    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

Secondary outcomes

  1. 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)

    Time frame: 6 weeks

    Assessment of hypoglycemia and hyperglycemia cases, average glycemic balance, glycemic variability, insulin doses

  2. Assessment of hypoglycemia occurrence during the night

    Time frame: 6 weeks

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

    Time frame: 6 weeks

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

    Time frame: 6 weeks

  5. Assessment of insulin doses delivered between 9 PM and 8 AM

    Time frame: 6 weeks

  6. Assessment of number of controller propositions rejected for security reasons

    Time frame: 6 weeks

  7. Assessment of glucose values during the night (glycemia and interstitial glucose values)

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Prospective, Monocentric, Crossover Randomized Trial, to Assess a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC)

Acronym: PPA

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 12, 2014
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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