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Completed

NCT Number: NCT04042207

Diabeloop for Highly Unstable Type 1 Diabetes

Feasibility study, comparing experimental treatment (DBLHU closed-loop system) with reference treatment (Low Glucose Predictive Suspend system) in 7 patients going through a series of N-of-1 trials. Each N-of-1 trial consists in a prospectively planned, multiple crossover study in a single individual. Two blocks of two periods of four weeks each (closed loop or open loop) will be conducted. Within each block, the sequence closed loop-open loop or open loop-close loop is randomized. Outcomes will be analyzed on the third and fourth weeks of period.

A remote monitoring system managed by specialized nurse on behalf of diabetologist, is provided in closed-loop session.

An extension period of 48 weeks with the DBLHU System (closed-loop condition) will be performed at the end of the crossover study phase in real life conditions (without remote monitoring).

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Key information

Conditions

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

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble Alpes University Hospital, Grenoble, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject (aged 22 or more) with Type 1 diabetes for at least 5 years and confirmed C peptide negative
  • Treated with continuous subcutaneous insulin infusion (CSII) for ≥ 6 months,
  • Trained to carbohydrate counting/flexible insulin therapy,
  • Subject that had experienced, despite optimal diabetes management and prior to any equipment with Smartguard technology, glucose instability as defined by at least 2 of the following criteria which would have led to eligibility for pancreatic islet transplantation:
  • occurrence of at least 1 severe hypoglycemic episode during the past 12 months (need for third party),
  • occurrence of ketoacidosis (hospitalization in ICU) without explanation
  • Impaired awareness of hypoglycemia (Clark Score ≥ 4; Gold Score > 4)
  • glucose levels: standard deviation > 50% of the arithmetic mean value on glucose meter or > 40 mg/dl on CGM on a 14-day recording
  • glucose levels: MAGE (mean amplitude of glucose excursions) index > 60 mg/dl
  • glucose levels: coefficient of variation (CV) > 36%
  • with persisting extreme glucose variability despite optimal medical care
  • with contra-indication or no agreement to undertake pancreatic islet transplantation or pancreas transplantation.
  • Subject willing to wear the DBLHU system continuously throughout the study

Exclusion criteria

  • patient with type 2 diabetes
  • age < 22 years old
  • patient without any social or familial support able to intervene in case of severe hypoglycemic event
  • any permanent and severe condition able to interact with the normal course of the study
  • patient with insulin-resistance defined by insulin requirements > 1.5U/kg/d
  • patient with a daily dose of insulin required greater than 90 units
  • patient receiving a total daily dose of insulin less than 8 U
  • use of any insulin that is not 100 U/mL fast-acting insulin analog
  • patient suffering from a serious illness or a treatment that might significantly impair diabetes physiology, i.e. glucose-insulin interactions, that might interfere with the medical device (for example irregular treatment of steroids)
  • patient having severe problems of uncorrected hearing and/or visual acuity
  • patient who is unable to understand and perform all the instructions provided by Diabeloop SA
  • patient not willing to perform ≥4 finger stick blood glucose measurements daily
  • patients that have frequent exposure to magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment.
  • patient who has had a pancreatectomy or who has pancreatic malfunctions
  • patient having severely altered renal function (Creatinine clearance < 30ml/min)
  • patient on dialysis
  • pregnancy or breast-feeding patient, or project of pregnancy during the next 6 months
  • lack of effective contraception in women of childbearing potential
  • all conditions excluding participation to clinical research as defined in France

Treatment and study plan

Low Glucose Predictive Suspend system

Device

consists of sensor-augmented pump therapy (SAP) / Low Glucose Predictive Suspend system (with predictive low glucose management technology)

Other names: Open-loop condition

DBLHU System

Device

DBLHU system embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.

Other names: Closed-loop condition

Primary outcomes

  1. Percentage of CGM time in glucose range 70-180 mg/dl, during 24 hours periods for the third and fourth week for each treatment period

    Time frame: 14 days for each treatment period

    Measured by continuous glucose monitoring

Secondary outcomes

  1. Evolution over time of the DBLHU system's performance on a day-to-day and determination of the optimization delay of glycemic control

    Time frame: Over twenty-four hour periods on the four weeks of each treatment period and of the 24-week and 48-week extented CL period.

    Measured by continuous glucose monitoring

  2. Percent of CGM time in glucose range 70-180 mg/dl during nighttime.

    Time frame: Overnight (defined as 00:00 to 06:00) periods on the third and fourth week of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.

    Measured by continuous glucose monitoring

  3. Percent of CGM time in glucose range 70-180 mg/dl during daytime.

    Time frame: Over daytime (defined as 06:00 to 00:00) periods on the third and fourth week of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.

    Measured by continuous glucose monitoring

  4. Percent of CGM time with glucose < 70mg/dl, < 60mg/dl, < 54mg/dl and < 50mg/dl

    Time frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.

    Measured by continuous glucose monitoring

  5. Percent of CGM time with glucose > 180mg/dl, > 250mg/dl, > 300mg/dl and > 360mg/dl

    Time frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.

    Measured by continuous glucose monitoring

  6. Average glycemia level

    Time frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.

    Measured by continuous glucose monitoring

  7. Estimated HbA1c (eHbA1c) levels / glucose management indicator (GMI)

    Time frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.

    Measured by continuous glucose monitoring

  8. HbA1c levels

    Time frame: HbA1c value at the week 24 and week 48 of extented CL period.

    Measured by blood sampling

  9. Glucose coefficient of variation (CV) and Standard deviation (SD)

    Time frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.

    Measured by continuous glucose monitoring

  10. Rate of CGM excursions below 54 mg/dl (3.0 mM) for at least 15 min

    Time frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.

    Mean time spent in hypoglycaemia, defined as sensor glucose values of 54 mg/dL (3∙0 mmol/L) or lower for more than 15 min consecutively

  11. Comparison of MAGE index and Low Blood Glucose Index (LBGI)

    Time frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during 24-week extension period

    Mean amplitude of glucose excursions and Low Glucose index as measured by continuous glucose monitoring

  12. Number of acute metabolic events (severe hypoglycemia, severe Diabetic Ketoacidosis [DKA])

    Time frame: During 4 weeks of each treatment period and during 24-week and 48-week extension period

    Measured by continuous glucose monitoring. Number of severe hypoglycemia is defined as any event requiring third party assistance.

    DKA events. Subjects will be asked to measure blood ketone levels on if their interstitial glucose is above 300 mg/l beyond the usual timeframe following a meal, as part of the safety evaluation for hyperglycemia.

  13. Number of severe hypoglycemia with loss of consciousness

    Time frame: During 4 weeks of each treatment period and during 24-week and 48-week extension period

    Number of severe hypoglycemia with loss of consciousness

  14. Number of hospitalizations for severe hypoglycemia or ketoacidosis

    Time frame: During 4 weeks of each treatment period and during 24-week and 48-week extension period

    Number of hospitalizations

  15. For the use and the acceptance, a satisfaction survey will be done on the daily management of diabetes, the modification of daily life with the system dan the fear of hypoglycemia

    Time frame: after baseline period (2-week); after crossover period; after 24-week and after 48-week extension period

    DTSQ satisfaction questionnaire, with scale from 6 to 0 where 0 is the worth and 6 the best outcome.

  16. Percentage of CGM time in glucose range 70-180 mg/dl, during 24 hours periods

    Time frame: 24-week and 48-week extension period

    Measured by continuous glucose monitoring

Sponsors and collaborators

Lead sponsor

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Other

Registry information

Official study title

In Adults With Very Unstable Type 1 Diabetes, is the DBLHU Closed-Loop Insulin Delivery System Able to Improve Blood Glycemic Control Compared to Low-Glucose-Predictive-Suspend System: Two-center, Randomized, Open-label Study

Acronym: DBLHU

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 1, 2019
Registry last updated
May 10, 2021

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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