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Trial record 15 of 873 for:    hypoglycemia | "Diabetes Mellitus, Insulin-Dependent"

Prevention of Hypoglycemia After Exercise Using Closed Loop System in Children and Adolescents With Type 1 Diabetes (PHYSI-DREAM)

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ClinicalTrials.gov Identifier: NCT02657083
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
University of Ljubljana, Faculty of Medicine

Brief Summary:

The Study will compare treatment with Closed Loop (CL) system - DreaMed MD-AID to the standard treatment without computer algorithm decisions - SAP therapy in 20 children and adolescents with Type 1 Diabetes (T1D) during and after afternoon physical activity.

The aims of the study are:

  • to demonstrate that the use of DreaMed MD-AID is safe during physical activity
  • to investigate the risk of hypoglycemia among children and adolescents with T1D after afternoon exercise during closed-loop control.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: DreaMed Substance Administration Device Device: Sensor Augmented Pump (SAP) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Prevention of Hypoglycemia After Exercise Using DreaMed Substance Administration Device in Children and Adolescents With Type 1 Diabetes (The PHYSI-DREAM Study)
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glucose control using DreaMed MD-AID
In this group the subjects use a closed loop system (DreaMed Substance Administration Device) that combines glucose monitoring system (S.C wired sensor, named Sof® Sensor™ or Enlite® Sensor™), which provides real-time interstitial glucose values, with a modern insulin pump (MiniMed® Paradigm® Veo™, Medtronic) and computer algorithm, which directs insulin delivery in response to glucose sensor data.
Device: DreaMed Substance Administration Device

2 exercise days under DreaMed MD-AID control with afternoon exercise (in the time between 16:30 and 19:30).

New infusion set and two continuous glucose sensors (one for back-up) will be inserted in the subcutaneous tissue of the arm and then calibrated the day before each visit from 3 to 6.

The continuous glucose sensor continuously will measure interstitial glucose levels and these values will be sent by the Minilink™ via wireless, low-powered, radio frequency to the Paradigm Veo every 5 minutes for up to 6 days.

The DreaMed MD-AID uses a vendor-supplied and self-developed (communication module) communication application programming interface (API) in order to retrieve glucose / insulin data from the Paradigm Veo and set insulin treatment according to the algorithm decision.


Active Comparator: Glucose control using SAP
In this group the subjects use a standard treatment (Sensor Augmented Pump), characterised by glucose monitoring system (S.C wired sensor, named Sof® Sensor™ or Enlite® Sensor™) which provides real-time interstitial glucose values and a modern insulin pump (MiniMed® Paradigm® Veo™, Medtronic) without computer algorithm decisions.
Device: Sensor Augmented Pump (SAP)

2 exercise days under Sensor Augmented Pump with afternoon exercise (in the time between 16:30 and 19:30).

New infusion set and two continuous glucose sensors (one for back-up) will be inserted in the subcutaneous tissue of the arm and then calibrated the day before each visit from 3 to 6.

The continuous glucose sensor continuously will measure interstitial glucose levels and these values will be sent by the Minilink™ via wireless, low-powered, radio frequency to the Paradigm Veo every 5 minutes for up to 6 days.

During the exercise the group will turn off the insulin pump and lower their basal insulin for 20% for the next 4 hours after the exercise





Primary Outcome Measures :
  1. to evaluate the safety and efficacy of blood glucose control using the DreaMed MD-AID in children and adolescents with T1D during and after planned physical activity, in a controlled in-hospital environment. [ Time Frame: After all patients completed their 30 days of study treatment. ]
    Primary endpoint is significant between-group difference (intervention DreaMed MD-AID versus control SAP) in time of hypoglycemia below 3.3 mmol/l (60 mg/dl) during the afternoon exercise and the afternoon/night after (till 13:00 next day) based on sensor glucose readings with a minimum duration of 20 minutes.


Secondary Outcome Measures :
  1. to evaluate the physiologic responses and risk of hypoglycemia among children and adolescents with T1D after afternoon exercise during closed-loop control in a controlled in-hospital environment [ Time Frame: After all patients completed their 30 days of study treatment. ]
    • Time of hypoglycemia below 3.9 mmol/l (70 mg/dl) based on sensor glucose readings.
    • Time of hyperglycemia above 13.9 mmol/l (250 mg/dl) based on sensor glucose readings.
    • Time of glucose values within 3.9 - 10 mmol/l (70-180 mg/dl).



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent signed by a parent/legal guardian and informed assent signed by the study participant prior study entry.
  • Diagnosed with T1D, as defined by the American Diabetes Association and World Health Organization (ADA/WHO) for at least 1 year prior to study enrolment.
  • Documented evidence should exist within the patient history of T1D.
  • Age between 10 and 17 years (inclusive) at the time of enrolment.
  • Treatment with insulin pump therapy for at least 3 months.
  • HbA1C value ≤ 9% based on analysis from the local laboratory at the time of enrolment (A1C testing must follow National Glycohemoglobin Standardization Program (NGSP) standards).
  • Willing to follow all study instructions (child and parent should be evaluated as one)
  • Availability for the entire study duration and follow-up visits
  • Willing to perform daily self-monitoring of blood glucose (SMBG) and required sensor calibrations
  • If also present celiac/Hashimoto disease, the disease has to be adequately treated as determined by the investigator
  • BMI above 5th centile and below 95th centile for age, respectively.

Exclusion Criteria:

  • Concomitant diseases that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency) or other medical conditions, which in the investigator's opinion, may compromise patient safety; Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
  • Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study (e.g. current treatment for cancer, mental disorder)
  • Any concomitant oral or parenteral glucocorticoids therapy within 1 month prior to screening, or planning to take oral or parenteral glucocorticoids during the study. (Exceptions: Short term oral glucocorticoids up to 7 days, inhaled steroids).
  • Any concomitant therapy with antidiabetic agents or other medications, which could be a contraindication to participation in the study by the judgment of the investigator.
  • Participation in another study of a medical device or drug that could affect glucose measurements or glucose management or Receipt of any investigational medical product within 1 month prior to screening (Visit 1).
  • Female subject of child-bearing potential who is pregnant, breast-feeding, or planning to become pregnant during the study.
  • Subject that has known hypoglycemic unawareness or recurrent severe hypoglycemic events with seizure and/or coma (more than two episodes) within 6 months prior to screening.
  • History of one or more episodes of Diabetic Ketoacidosis (DKA) requiring hospitalization within a month prior to the screening.
  • Current or recent history of alcohol or drug abuse.
  • Visual impairment or hearing loss, which in the investigator's opinion, may compromise patient ability to perform study procedures safely (child and parent should be evaluated as a unit).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657083


Locations
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Slovenia
University of Ljubljana, Faculty of Medicine
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University of Ljubljana, Faculty of Medicine
Investigators
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Principal Investigator: Tadej Battelino, Prof, MD University of Ljubljana, Faculty of Medicine

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Ljubljana, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT02657083     History of Changes
Other Study ID Numbers: PD-MC-01
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: August 2016

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs