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Diabetes Mellitus Type 1NCT02465411

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

A study testing Dexcom G4 or later generation in people with Diabetes Mellitus Type 1, run by Vastra Gotaland Region at 15 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus Type 1
What is being tested?
Dexcom G4 or later generation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
15 sitesSweden
Study dates
Jun 2015to 31 May 2017
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Sweden15 sites

  • Alingsås Hospital

    Alingsås

  • Ängelholm Hospital

    Ängelholm

  • Angered Hospital

    Angered

  • Öbackakliniken

    Härnösand

  • Helsingborg Hospital

    Helsingborg

  • Central Hospital Kristianstad

    Kristianstad

  • Halland Hospital Kungsbacka

    Kungsbacka

  • Skåne University Hospital Malmö

    Malmö

  • Hospital in Motala

    Motala

  • Vrinnevi Hospital

    Norrköping

  • University Hospital Örebro

    Örebro

  • Södersjukhuset

    Stockholm

  • Hospital Trelleborg

    Trelleborg

  • NU Hospital Group

    Uddevalla

  • Academic Hospital Uppsala

    Uppsala

Other trials in Sweden

About this study

Official title: 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.

Being tested
Dexcom G4 or later generation
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • Dexcom G4 or later generationDevice

    Continuous glucose monitoring with DexCom G4 platina or later generations

Study groups in NCT02465411
Study groupRoleWhat they receive
Long-term CGMExperimentalContinuous glucose monitoring with DexCom G4 platina or later generations during 12 months following participation in the CGMMDI trial
Receives: Device: Dexcom G4 or later generation

What is being measured

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

  1. HbA1c in venous sample

    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.

    Measured: 52 weeks or 78 weeks

Secondary outcomes (15)

  1. Mean glucose level measured by CGM during two weeks.

    Measured: 52 weeks/78 weeks

  2. Mean Amplitude of Glycemic Excursions (MAGE) measured by CGM during two weeks.

    Measured: 52 weeks/78 weeks

  3. Standard deviation of glucose levels measured by CGM during two weeks.

    Measured: 52 weeks/78 weeks

  4. Treatment satisfaction: DTSQs scores

    Diabetes Treatment Satisfaction Questionnaire (Status)

    Measured: 52 weeks/78 weeks

  5. Well being: WHO 5 scores

    Questionnaire

    Measured: 52 weeks/78 weeks

  6. Hypoglycemia fear: SWE-HFS scores

    Swedish Hypoglycaemia Fear Scale Questionnaire

    Measured: 52 weeks/78 weeks

  7. Problem areas: SWE-PAID-20 scores

    Swedish Problem Areas In Diabetes Questionnaire

    Measured: 52 weeks/78 weeks

  8. Physical activity: IPAQ score

    International Physical Activity Questionnaire

    Measured: 52 weeks/78 weeks

  9. Treatment experience of CGM score

    Questionnaire developed for this trial

    Measured: 52 weeks/78 weeks

  10. Proportion of time with low glucose levels measured by CGM during two weeks.

    Below 3.0 mmol/l and below 4.0 mmol/l, respectively.

    Measured: 52 weeks/78 weeks

  11. Proportion of time with high glucose levels measured by CGM during two weeks.

    Above 10.0 mmol/l and above 13.9 mmol/l, respectively.

    Measured: 52 weeks/78 weeks

  12. Proportion of time with euglycaemic levels measured by CGM during two weeks.

    5.5-10.0 mmol/l and 3.9-10.0 mmol/l, respectively.

    Measured: 52 weeks/78 weeks

  13. Proportion of patients lowering their HbA1c by 5 mmol/mol (0.5% in DCCT) or more.

    Measured: 52 weeks/78 weeks

  14. Proportion of patients lowering their HbA1c 10 mmol/mol (1% in DCCT) or more

    Measured: 52 weeks/78 weeks

  15. Number of self-reported severe hypoglycaemic events per year

    Defined as unconsciousness due to hypoglycaemia or need for assistance from another person to resolve hypoglycaemia.

    Measured: 52 weeks/78 weeks

Timeline

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

  1. First posted8 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completion31 May 2017
  4. Study completion31 May 2017

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02465411
Sponsor's protocol ID
CGMMDI Extension
Status last verified
Nov 2016
First submitted
26 May 2015
Last updated
8 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • Lind M, Olafsdottir AF, Hirsch IB, Bolinder J, Dahlqvist S, Pivodic A, Hellman J, Wijkman M, Schwarcz E, Albrektsson H, Heise T, Polonsky W. Sustained Intensive Treatment and Long-term Effects on HbA1c Reduction (SILVER Study) by CGM in People With Type 1 Diabetes Treated With MDI. Diabetes Care. 2021 Jan;44(1):141-149. doi: 10.2337/dc20-1468. Epub 2020 Nov 15.

    PubMed 33199470

Questions about this trial

What is this clinical trial studying?

A study testing Dexcom G4 or later generation in people with Diabetes Mellitus Type 1, run by Vastra Gotaland Region at 15 sites in Sweden.

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 2 inclusion and 6 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: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

HbA1c in venous sample (time frame: 52 weeks or 78 weeks). 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 NCT02465411, which also lists 1 linked publication.

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 8 Nov 2017.

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