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Can Continuous Glucose Measurements Help Diabetic Patients Treated With an Implantated Pump? (CGMIP)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03048227
Recruitment Status : Terminated (CGM Navigator isn't longer available (October 11, 2019))
First Posted : February 10, 2017
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
During this study, we propose to assess the utility of Continuous Glucose Measurements (CGM) in a group of Type 1 diabetic patients treated with an implanted insulin pump. Patients will participate in two period of 3 months separated by a 3 months washout. During one period, they will use CGM to adapt their insulin therapy while during the other period, they will manage their diabetes with their usual capillary blood glucose meter. We except to observe an increase of time spent in glucose safe range when using CGM.

Condition or disease Intervention/treatment Phase
Type1diabetes Device: Continuous Glucose Measurement (CGM) Not Applicable

Detailed Description:

Glucose control and quality of life of patients with type 1 diabetes with high glucose variability can be improve with use of an implanted pump which delivers insulin by the intra-peritoneal route. Some patients however still have difficulties to achieve their glycemic goal despite this therapy. Continuous Glucose Measurements (CGM) has proven to be able to improve glucose control (HbA1c, time spent in hypoglycaemia) of patients treated with an external insulin pump. No trial has been performed yet to assess the utility of CGM on patients using an intra-peritoneal insulin delivery.

During this study, we propose to assess the influence of CGM use on type 1 diabetic subject treated with implanted insulin pump. It is a prospective, randomized cross-over study. After a 2 weeks run-in period with CGM followed by a 4 weeks break, subjects will participate at two experimental periods of 3 months separated with a 3 month washout. During the intervention phase, patient will use a CGM system (Abbott Freestyle Navigator II) to adapt their insulinotherapy. During the control period, patients will based their insulinotherapy upon their usual care and capillary glucose measurements. The order of the periods will be randomized.

The main endpoint will be the time spent in glucose interval 70-180mg/dL during the last 20 days of each period. The control arm will wear a blinded sensor during this phase to allow comparison.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Assessement of the Influence of Continuous Glucose Measurement on Glucose Control of Type 1 Diabetic Patients Treated by Implanted Insulin Pump
Actual Study Start Date : April 21, 2017
Actual Primary Completion Date : February 15, 2019
Actual Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Continuous Glucose Measurement (CGM)
Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).
Device: Continuous Glucose Measurement (CGM)
Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).

No Intervention: Control
Patients will manage their diabetes as usual as recommended by their care team.



Primary Outcome Measures :
  1. Time spent with glucose [ Time Frame: last 20 days of intervention period ]
    Time spent with glucose between 70-180mg/dL


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: last 20 days of intervention period ]
    HbA1c

  2. Time spent in hypoglycaemia [ Time Frame: last 20 days of intervention period ]
    Time spent in hypoglycaemia (<70mg/dL)

  3. Time spent in hyperglycemia [ Time Frame: last 20 days of intervention period ]
    Time spent in hyperglycemia (>180mg/dL)

  4. Time spent in glucose range [ Time Frame: last 20 days of intervention period ]
    Time spent in glucose range [70-180] and [80-140] mg/dL

  5. Glucose mean and standard deviation [ Time Frame: last 20 days of intervention period ]
    Glucose mean and standard deviation

  6. Low Blood Glucose Index (LBGI) [ Time Frame: last 20 days of intervention period ]
    Low Blood Glucose Index (LBGI)

  7. High Blood Glucose Index (HBGI) [ Time Frame: last 20 days of intervention period ]
    High Blood Glucose Index (HBGI)

  8. Glucose Variability [ Time Frame: last 20 days of intervention period ]
    Glucose Variability: MARD : Mean Absolute Relative Difference

  9. Glucose Variability [ Time Frame: last 20 days of intervention period ]

    Glucose Variability: MAGE : Mean Amplitude of Glucose Excursions

    -MODD : Mean Of daily blood Glucose Difference


  10. Glucose Variability [ Time Frame: last 20 days of intervention period ]
    Glucose Variability: MODD : Mean Of daily blood Glucose Difference

  11. Number of symptomatique hypoglycaemia, severe et non severe [ Time Frame: last 20 days of intervention period ]
    Number of symptomatique hypoglycaemia, severe et non severe

  12. Number of pump programmation [ Time Frame: last 20 days of intervention period ]
    Number of pump programmation

  13. Percentage of sensor use [ Time Frame: last 20 days of intervention period ]
    Percentage of sensor use

  14. Score of Quality of Life questionnaire (IDSRQ) [ Time Frame: last 20 days of intervention period ]
    Score of Quality of Life questionnaire (IDSRQ)



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 to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age from 18 and 70
  • Type 1 diabetes for at least 1 year
  • Treatment of diabetes withimplanted insulin pump for at least 6 months
  • HbA1c level between 7.5 and 10%
  • Minimum of 4 capillary glucose controls per day over past 3 months
  • Use of CGM at least 75% during run-in period
  • Willingness to follow all study procedures
  • Informed consent signed
  • Patient must be affiliated or beneficiary of a social medical insurance

Exclusion Criteria:

  • Pregnancy of breast feeding, or intention to be pregnant during the study duration
  • Impaired cognitive or psychological abilities which may result in defective adherence to study procedures
  • Any disease which could make the use glucose sensor difficult (ex : blindness, severe arthrosis or immobility)
  • Known allergy to medical adhesive or glucose sensor component
  • Medication affecting glucose metabolism, unless stable during the study
  • Long term use of continuous glucose measurements during pas 6 months
  • Pump implanted more than 6 years ago
  • Anti-insulin antobodies syndrom
  • Active enrollment in another clinical trial or participation in a study within 30 days

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): NCT03048227


Locations
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France
Chu de Nancy
Nancy, Vandoeuvre-les-nancy, France, 54500
CHU de Bordeaux
Bordeaux, France, 33078
CH Sud Francilien
Corbeil-essonnes, France, 91100
CHU de Dijon
Dijon, France, 77908
CHRU de Lille
Lille, France, 59037
AP - Hôpitaux de Marseille
Marseille, France, 13005
UHMontpellier
Montpellier, France, 34295
AP - Hôpitaux de Paris
Paris, France, 75014
CHRU de Strasbourg
Strasbourg, France, 67091
Chu de Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Eric RENARD, MD University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03048227    
Other Study ID Numbers: UF9773
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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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 University Hospital, Montpellier:
TIDM
Type1diabetes
Implantable Pump
CGM
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases