Long Term CGM Treatment in Patients With Type 1 Diabetes Treated With Insulin Injections

November 7, 2017 updated by: Vastra Gotaland Region

Long-term Effects of Continuous Glucose Monitoring in Patients With Type 1 Diabetes Treated With Multiple Daily Insulin Injections - Extension of CGMMDI Trial

A keystone in preventing diabetic complications in patients with type 1 diabetes is good glycaemic control. Frequent self-measurements of blood glucose (SMBG) levels have been an essential part of insulin dosing before meals. However, in recent years continuous glucose monitoring (CGM) has become a treatment option to inform the patient when glucose levels may be too high or low.

In some countries, including Sweden, CGM is reimbursed only when combined with continuous subcutaneous insulin infusions (CSII) in patients with very poor glycaemic control or a history of repeated severe hypoglycaemia in adults with type 1 diabetes. This is based on existing clinical trial data showing a beneficial effect on HbA1c when CGM is combined with CSII. However, despite the fact that the majority of adults with type 1 diabetes are treated with multiple daily insulin injections (MDI), studies on the effect of CGM in patients with type 1 diabetes treated with MDI are sparse. Therefore, the investigators initiated the CGMMDI trial, an ongoing, cross-over clinical trial including 161 MDI patients receiving CGM over 6 months, followed by conventional therapy over six months, with a four-month wash-out period in-between treatment. Evaluations include glycaemic control, hypoglycaemia, quality of life, fear of hypoglycaemia, treatment satisfaction, physical activity, and safety.

From a research or regulatory standpoint, long-term data on treatment effects are expected to a greater extent today than in previous years, due to various reasons, e.g., to evaluate any sustained beneficial effects over time, or long-term patient safety. Accordingly, follow-up of treatment in an extension phase after randomized diabetes trials have become more common over time, especially where many novel glucose-lowering treatments are concerned. Therefore, the aim of the current study is to evaluate long-term effects of CGM in patients with type 1 diabetes treated with MDI. Patients who consent in an extension phase over 1 year of the CGMMDI trial will receive CGM, and evaluations will be performed on sustained glycaemic control effects, hypoglycaemia, glycaemic variability, quality of life, fear of hypoglycaemia, treatment satisfaction, physical activity, and safety.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Alingsås, Sweden
        • Alingsås Hospital
      • Angered, Sweden
        • Angered Hospital
      • Helsingborg, Sweden
        • Helsingborg Hospital
      • Härnösand, Sweden
        • Öbackakliniken
      • Kristianstad, Sweden
        • Central Hospital Kristianstad
      • Kungsbacka, Sweden
        • Halland Hospital Kungsbacka
      • Malmö, Sweden
        • Skane University Hospital Malmo
      • Motala, Sweden
        • Hospital in Motala
      • Norrköping, Sweden
        • Vrinnevi Hospital
      • Stockholm, Sweden
        • Södersjukhuset
      • Trelleborg, Sweden
        • Hospital Trelleborg
      • Uddevalla, Sweden
        • NU Hospital Group
      • Uppsala, Sweden
        • Academic Hospital Uppsala
      • Ängelholm, Sweden
        • Ängelholm Hospital
      • Örebro, Sweden
        • University Hospital Örebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completion of the CGMMDI trial.
  • Written informed consent.

Exclusion Criteria:

  • Pregnancy, planned pregnancy for the study duration or pregnancy during the last six months
  • Severe cognitive dysfunction or other disease, which is adjudicated by a physician as not suitable for inclusion.
  • Required continuous use of paracetamol. Paracetamol must not have been used the week before the study and shall not be used during CGM-use because it disturbs the interpretation of blood glucose levels estimated by the Dexcom. However, other pain killers can be used throughout the study duration.
  • History of allergic reaction to any of the CGM materials or adhesives in contact with the skin, or to chlorhexidine or alcoholic anti-septic solution.
  • Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
  • Other investigator-determined criteria making patients unsuitable for participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Long-term CGM
Continuous glucose monitoring with DexCom G4 platina or later generations during 12 months following participation in the CGMMDI trial
Device: Dexcom G4 or later generation
Continuous glucose monitoring with DexCom G4 platina or later generations

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c in venous sample
Time Frame: 52 weeks or 78 weeks
For all variables, measurement at the end of this extension of a cross-over study will be compared to the measurement before long-term CGM was initiated.
52 weeks or 78 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean glucose level measured by CGM during two weeks.
Time Frame: 52 weeks/78 weeks
52 weeks/78 weeks
Mean Amplitude of Glycemic Excursions (MAGE) measured by CGM during two weeks.
Time Frame: 52 weeks/78 weeks
52 weeks/78 weeks
Standard deviation of glucose levels measured by CGM during two weeks.
Time Frame: 52 weeks/78 weeks
52 weeks/78 weeks
Treatment satisfaction: DTSQs scores
Time Frame: 52 weeks/78 weeks
Diabetes Treatment Satisfaction Questionnaire (Status)
52 weeks/78 weeks
Well being: WHO 5 scores
Time Frame: 52 weeks/78 weeks
Questionnaire
52 weeks/78 weeks
Hypoglycemia fear: SWE-HFS scores
Time Frame: 52 weeks/78 weeks
Swedish Hypoglycaemia Fear Scale Questionnaire
52 weeks/78 weeks
Problem areas: SWE-PAID-20 scores
Time Frame: 52 weeks/78 weeks
Swedish Problem Areas In Diabetes Questionnaire
52 weeks/78 weeks
Physical activity: IPAQ score
Time Frame: 52 weeks/78 weeks
International Physical Activity Questionnaire
52 weeks/78 weeks
Treatment experience of CGM score
Time Frame: 52 weeks/78 weeks
Questionnaire developed for this trial
52 weeks/78 weeks
Proportion of time with low glucose levels measured by CGM during two weeks.
Time Frame: 52 weeks/78 weeks
Below 3.0 mmol/l and below 4.0 mmol/l, respectively.
52 weeks/78 weeks
Proportion of time with high glucose levels measured by CGM during two weeks.
Time Frame: 52 weeks/78 weeks
Above 10.0 mmol/l and above 13.9 mmol/l, respectively.
52 weeks/78 weeks
Proportion of time with euglycaemic levels measured by CGM during two weeks.
Time Frame: 52 weeks/78 weeks
5.5-10.0 mmol/l and 3.9-10.0 mmol/l, respectively.
52 weeks/78 weeks
Proportion of patients lowering their HbA1c by 5 mmol/mol (0.5% in DCCT) or more.
Time Frame: 52 weeks/78 weeks
52 weeks/78 weeks
Proportion of patients lowering their HbA1c 10 mmol/mol (1% in DCCT) or more
Time Frame: 52 weeks/78 weeks
52 weeks/78 weeks
Number of self-reported severe hypoglycaemic events per year
Time Frame: 52 weeks/78 weeks
Defined as unconsciousness due to hypoglycaemia or need for assistance from another person to resolve hypoglycaemia.
52 weeks/78 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
DexCom, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marcus Lind, MD, PhD, NU Hospital Group and University of Gothenburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CGMMDI Extension

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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