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Type1diabetesCGMIPNCT03048227

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

A study testing Continuous Glucose Measurement (CGM) in people with Type1diabetes, run by University Hospital, Montpellier at 10 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type1diabetes
What is being tested?
Continuous Glucose Measurement (CGM)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
10 sitesFrance
Study dates
21 Apr 2017to 21 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Willingness to follow all study procedures
  • Informed consent signed
  • Patient must be affiliated or beneficiary of a social medical insurance

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites

  • CHU de Bordeaux

    Bordeaux, 33078

  • CH Sud Francilien

    Corbeil-Essonnes, 91100

  • CHU de Dijon

    Dijon, 77908

  • CHRU de Lille

    Lille, 59037

  • AP - Hôpitaux de Marseille

    Marseille, 13005

  • UHMontpellier

    Montpellier, 34295

  • Chu de Nancy

    Nancy, Vandoeuvre-les-nancy, 54500

  • AP - Hôpitaux de Paris

    Paris, 75014

  • CHRU de Strasbourg

    Strasbourg, 67091

  • Chu de Toulouse

    Toulouse, 31059

Other trials in France

About this study

Official title: Assessement of the Influence of Continuous Glucose Measurement on Glucose Control of Type 1 Diabetic Patients Treated by Implanted Insulin Pump

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.

Read the 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.

Conditions
Type1diabetes
Being tested
Continuous Glucose Measurement (CGM)
Keywords
TIDM, Type1diabetes, Implantable Pump, CGM

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Glucose Measurement (CGM)Device

    Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).

Study groups in NCT03048227
Study groupRoleWhat they receive
Continuous Glucose Measurement (CGM)ExperimentalPatients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).
Receives: Device: Continuous Glucose Measurement (CGM)
ControlNo interventionPatients will manage their diabetes as usual as recommended by their care team.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time spent with glucose

    Time spent with glucose between 70-180mg/dL

    Measured: last 20 days of intervention period

Secondary outcomes (14)

  1. HbA1c

    HbA1c

    Measured: last 20 days of intervention period

  2. Time spent in hypoglycaemia

    Time spent in hypoglycaemia (<70mg/dL)

    Measured: last 20 days of intervention period

  3. Time spent in hyperglycemia

    Time spent in hyperglycemia (>180mg/dL)

    Measured: last 20 days of intervention period

  4. Time spent in glucose range

    Time spent in glucose range [70-180] and [80-140] mg/dL

    Measured: last 20 days of intervention period

  5. Glucose mean and standard deviation

    Glucose mean and standard deviation

    Measured: last 20 days of intervention period

  6. Low Blood Glucose Index (LBGI)

    Low Blood Glucose Index (LBGI)

    Measured: last 20 days of intervention period

  7. High Blood Glucose Index (HBGI)

    High Blood Glucose Index (HBGI)

    Measured: last 20 days of intervention period

  8. Glucose Variability

    Glucose Variability: MARD : Mean Absolute Relative Difference

    Measured: last 20 days of intervention period

  9. Glucose Variability

    Glucose Variability: MAGE : Mean Amplitude of Glucose Excursions

    -MODD : Mean Of daily blood Glucose Difference

    Measured: last 20 days of intervention period

  10. Glucose Variability

    Glucose Variability: MODD : Mean Of daily blood Glucose Difference

    Measured: last 20 days of intervention period

  11. Number of symptomatique hypoglycaemia, severe et non severe

    Number of symptomatique hypoglycaemia, severe et non severe

    Measured: last 20 days of intervention period

  12. Number of pump programmation

    Number of pump programmation

    Measured: last 20 days of intervention period

  13. Percentage of sensor use

    Percentage of sensor use

    Measured: last 20 days of intervention period

  14. Score of Quality of Life questionnaire (IDSRQ)

    Score of Quality of Life questionnaire (IDSRQ)

    Measured: last 20 days of intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2017 (estimated)
  2. Study start21 Apr 2017
  3. Primary completion21 Mar 2020
  4. Study completion21 Mar 2020

Why it stopped: CGM Navigator isn't longer available (October 11, 2019)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03048227
Sponsor's protocol ID
UF9773
Acronym
CGMIP
Status last verified
Dec 2021
First submitted
23 Jan 2017
Last updated
9 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: NC

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Glucose Measurement (CGM) in people with Type1diabetes, run by University Hospital, Montpellier at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: CGM Navigator isn't longer available (October 11, 2019)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time spent with glucose (time frame: last 20 days of intervention period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03048227.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.

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