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Completed

NCT Number: NCT02465411

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

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.

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Key information

Conditions

Diabetes Mellitus Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alingsås Hospital, Alingsås, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexcom G4 or later generation

Device

Continuous glucose monitoring with DexCom G4 platina or later generations

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 52 weeks/78 weeks

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

    Time frame: 52 weeks/78 weeks

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

    Time frame: 52 weeks/78 weeks

  4. Treatment satisfaction: DTSQs scores

    Time frame: 52 weeks/78 weeks

    Diabetes Treatment Satisfaction Questionnaire (Status)

  5. Well being: WHO 5 scores

    Time frame: 52 weeks/78 weeks

    Questionnaire

  6. Hypoglycemia fear: SWE-HFS scores

    Time frame: 52 weeks/78 weeks

    Swedish Hypoglycaemia Fear Scale Questionnaire

  7. Problem areas: SWE-PAID-20 scores

    Time frame: 52 weeks/78 weeks

    Swedish Problem Areas In Diabetes Questionnaire

  8. Physical activity: IPAQ score

    Time frame: 52 weeks/78 weeks

    International Physical Activity Questionnaire

  9. Treatment experience of CGM score

    Time frame: 52 weeks/78 weeks

    Questionnaire developed for this trial

  10. 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.

  11. 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.

  12. 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.

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

    Time frame: 52 weeks/78 weeks

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

    Time frame: 52 weeks/78 weeks

  15. 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.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • DexCom, Inc.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2015
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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