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ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes (ADAPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04235504
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Brief Summary:
The purpose of this study evaluate the safety and efficacy of the Advanced Hybrid Closed Loop (AHCL) system in sub‐optimally controlled patients with T1D, in comparison with Multiple Daily Injection (MDI) therapy with Flash Glucose Monitoring (FGM) or Continuous Glucose Monitoring (CGM). Patient with a diagnosis of Type 1 diabetes currently under MDI+ FGM or MDI+ CGM therapy will be enrolled.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: MDI Device: AHCL Not Applicable

Detailed Description:

This study is a pre‐market, multi‐center, prospective, open label, adaptative, randomized controlled trial in insulin‐requiring adult subjects with type 1 diabetes on MDI therapy. The study will have three period:

  1. Run-in Phase: The Run-in period is of 4 weeks (and can be extended for 2 additional ones) during which time a blinded CGM sensor will be worn for two weeks.
  2. Study Phase: There will be a 6 months randomized study period with two arms: Treatment Arm (AHCL) and the Control Arm.
  3. Continuation Phase: There will be a 6 months continuation phase during which time all the subjects will use the AHCL system.

Approximately 124 subjects will be enrolled in the study up to 20 investigational centers in EMEA.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

There will be 2 Cohort for this study:

  1. Cohort A: Subjects on MDI + FGM will be randomized into: Treatment Arm (AHCL) and Control Arm (MDI+ FGM)
  2. Cohort B: Subjects on MDI + Real‐Time CGM will be randomized into: Treatment Arm (AHCL) and Control Arm (MDI+ CGM) (exploratory analysis)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes
Estimated Study Start Date : January 29, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : August 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Control Arm
The Control Arm will use individual subject's current diabetes therapy (MDI+FGM or MDI+CGM) for 6 months during the Study Phase. During the Continuation Phase of 6 months Control Arm will start using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0
Other: MDI
Subject continues their standard Multiple Daily Injections therapy with FGM or RT-CGM

Device: AHCL

Subject starts using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0.

Starting time depends on which Arm the subject is assigned to: if the subject is assigned to the Treatment Arm, then the intervention starts after the RUN-IN period. If the subject is assigned to the Control Arm the intervention will start after 6 months from the date of the enrollment.


Experimental: Treatment Arm
The Treatment Arm will use the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0 for 6 months during the Study Phase and other 6 months during the Continuation Phase.
Device: AHCL

Subject starts using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0.

Starting time depends on which Arm the subject is assigned to: if the subject is assigned to the Treatment Arm, then the intervention starts after the RUN-IN period. If the subject is assigned to the Control Arm the intervention will start after 6 months from the date of the enrollment.





Primary Outcome Measures :
  1. HbA1c 6 months change between AHCL and MDI [ Time Frame: 0-6 months ]
    The difference in the mean HbA1c change (6 months ‐ baseline) between the AHCL and the MDI + FGM arm will be evaluated (Cohort A)


Secondary Outcome Measures :
  1. TIR between 70-180 mg/dL [ Time Frame: 0-6 months ]
    % Time spent within range with sensor glucose (SG) between 70 ‐ 180 mg/dL (3.9‐10.0 mmol/L). The comparison will be done between AHCL and MDI + FGM (Cohort A).

  2. Time in Hyperglycemic range [ Time Frame: 0-6 months ]
    % Time spent in hyperglycemic range with SG > 180 mg/dL (> 10.0 mmol/L). The comparison will be done between AHCL and MDI + FGM (Cohort A).

  3. Hypoglycemic events [ Time Frame: 0-6 months ]
    Number of biochemical hypoglycemic events< 54 mg/dL (3.0 mmol/L) (defined as sensor values < 54 mg/dL (3.0 mmol/L) per 15 consecutive minutes (Danne, 2017). When the time between two successive events is less than 30 minutes, they will be combined and counted as one event. The comparison will be done between AHCL and MDI + FGM (Cohort A).


Other Outcome Measures:
  1. HbA1c 6 months change between AHCL and MDI [ Time Frame: 0-6 months ]
    The difference in the mean HbA1c change (6 months ‐ baseline) between the AHCL and the MDI + CGM arm will be evaluated (Cohort B)

  2. TIR between 70-180 mg/dL [ Time Frame: 0-6 months ]
    % Time spent within range with sensor glucose (SG) between 70 ‐ 180 mg/dL (3.9‐10.0 mmol/L). The comparison will be done between AHCL and MDI + CGM (Cohort B).

  3. Time in Hyperglycemic range [ Time Frame: 0-6 months ]
    % Time spent in hyperglycemic range with SG > 180 mg/dL (> 10.0 mmol/L). The comparison will be done between AHCL and MDI + CGM (Cohort B).

  4. Hypoglycemic events [ Time Frame: 0-6 months ]
    Number of biochemical hypoglycemic events< 54 mg/dL (3.0 mmol/L) (defined as sensor values < 54 mg/dL (3.0 mmol/L) per 15 consecutive minutes (Danne, 2017). When the time between two successive events is less than 30 minutes, they will be combined and counted as one event. The comparison will be done between AHCL and MDI + CGM (Cohort B).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is age ≥ 18 years old at time of screening
  2. Subject has a clinical diagnosis of Type 1 diabetes for ≥ 2 years prior to screening as determined via source documentation
  3. On MDI therapy (defined as ≥ 3 insulin injections per day and/or a basal/bolus regimen) ≥ 2 years prior to screening
  4. Subject has been followed and treated by the investigator at this investigational site for at least 6 months prior to screening and subject has already undergone local educational therapeutic programs.
  5. Subject is using:

    • Flash Glucose Monitoring (FGM) for ≥ 3 months with a daily average number of scans ≥ 5 over and with sensor readings > 70% of time over the previous month prior to screening (based on sensor usage from the download summary report of the FGM system over 30 days prior to screening) Or
    • Continuous Glucose Monitoring (CGM) for ≥ 3 months with a frequency of sensor use ≥ 70% of the time over the previous month prior to screening (based on download summary report from the CGM system over 30 days prior to screening).
  6. Subject has a glycosylated hemoglobin (HbA1c) ≥ 8.0% (64 mmol/mol) at time of screening visit (as processed by a Central Lab).
  7. Subject is willing to take or switch to one of the following insulins:

    1. Humalog™ (insulin lispro injection)
    2. NovoLog™ (insulin aspart)
  8. Subject must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 8 units and a maximum of 250 units.
  9. Subject is willing to upload data from the study pump and meter, must have Internet access and a compatible computer system that meets the requirements for uploading the study pump data at home.
  10. Subject is willing and able to sign and date informed consent, comply with all study procedures and wear all study devices, as required during the study.

Exclusion Criteria:

  1. Subject has untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
  2. Subject is using pramlintide, DPP‐4 inhibitor, GLP‐1 agonists/mimetics, metformin, SGLT2 inhibitors at time of screening.
  3. Subject has had renal failure defined by creatinine clearance <30 ml/min, as assessed by local lab test ≤ 3 months before screening or performed at screening at local lab, as defined by the creatinine‐based Cockcroft or MDRD equations.
  4. Subject is planning to switch from FGM to CGM therapy during the 6 months study phase. Note: Subject randomized to Control Arm should remain on their current FGM or CGM therapy during the study phase and will be switched to AHCL during the continuation phase.
  5. Subject has a history of hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices, per investigator judgment.
  6. Women of child‐bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.
  7. Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study, per investigator judgment.
  8. Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
  9. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study.
  10. Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
  11. Subject has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
  12. Subject is legally incompetent, illiterate or vulnerable person.
  13. Research staff involved with the study.

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): NCT04235504


Contacts
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Contact: Roseline Re +33684520425 roseline.re@medtronic.com
Contact: Linda Vorrink +41 79 865 8140 linda.vorrink@medtronic.com

Locations
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France
Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz
Besançon, France
CHU de Bordeaux - Hôpital Saint André
Bordeaux, France
Principal Investigator: Bogdan Catargi         
CHU Caen
Caen, France
Principal Investigator: Yves Reznik         
APM - Hôpital de la Conception
Marseille, France
Hospital Civil
Strasbourg, France
Germany
Diabetologische Schwerpunktpraxis Dr. Ralf Kolassa
Bergheim, Germany
Diabetologikum Duisburg Diabetologische Schwerpunktpraxis
Duisburg, Germany
Zentrum für Diabetologie Bergedorf
Hamburg, Germany
Gemeinschaftspraxis im Westtor Hausarztpraxis & Diabetologische Schwerpunktpraxis
Lage, Germany
Medical Center am Clemenshospital Dr. Winfried Keuthage
Münster, Germany
United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Cambridge, United Kingdom
Harrogate and District Hospital - NHS Foundation Trust
Harrogate, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Manchester Diabetes Centre - Manchester Royal Infirmary
Manchester, United Kingdom
Sponsors and Collaborators
Medtronic Diabetes

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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT04235504    
Other Study ID Numbers: CIP327
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medtronic Diabetes:
Advanced Hybrid Closed Loop
Multiple Daily Injections
Flash Glucose Monitoring
Continuous Glucose Monitoring
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases