Long Term CGM Treatment in Patients With Type 1 Diabetes Treated With Insulin Injections
- Conditions
- Diabetes Mellitus Type 1
- Interventions
- Device: Dexcom G4 or later generation
- Registration Number
- NCT02465411
- Lead Sponsor
- Vastra Gotaland Region
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Completion of the CGMMDI trial.
- Written informed consent.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Long-term CGM Dexcom G4 or later generation Continuous glucose monitoring with DexCom G4 platina or later generations during 12 months following participation in the CGMMDI trial
- Primary Outcome Measures
Name Time Method HbA1c in venous sample 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 Outcome Measures
Name Time Method Physical activity: IPAQ score 52 weeks/78 weeks International Physical Activity Questionnaire
Treatment experience of CGM score 52 weeks/78 weeks Questionnaire developed for this trial
Well being: WHO 5 scores 52 weeks/78 weeks Questionnaire
Proportion of time with low glucose levels measured by CGM during two weeks. 52 weeks/78 weeks Below 3.0 mmol/l and below 4.0 mmol/l, respectively.
Proportion of time with euglycaemic levels measured by CGM during two weeks. 52 weeks/78 weeks 5.5-10.0 mmol/l and 3.9-10.0 mmol/l, respectively.
Proportion of patients lowering their HbA1c by 5 mmol/mol (0.5% in DCCT) or more. 52 weeks/78 weeks Hypoglycemia fear: SWE-HFS scores 52 weeks/78 weeks Swedish Hypoglycaemia Fear Scale Questionnaire
Problem areas: SWE-PAID-20 scores 52 weeks/78 weeks Swedish Problem Areas In Diabetes Questionnaire
Mean glucose level measured by CGM during two weeks. 52 weeks/78 weeks Mean Amplitude of Glycemic Excursions (MAGE) measured by CGM during two weeks. 52 weeks/78 weeks Standard deviation of glucose levels measured by CGM during two weeks. 52 weeks/78 weeks Proportion of time with high glucose levels measured by CGM during two weeks. 52 weeks/78 weeks Above 10.0 mmol/l and above 13.9 mmol/l, respectively.
Proportion of patients lowering their HbA1c 10 mmol/mol (1% in DCCT) or more 52 weeks/78 weeks Treatment satisfaction: DTSQs scores 52 weeks/78 weeks Diabetes Treatment Satisfaction Questionnaire (Status)
Number of self-reported severe hypoglycaemic events per year 52 weeks/78 weeks Defined as unconsciousness due to hypoglycaemia or need for assistance from another person to resolve hypoglycaemia.
Trial Locations
- Locations (15)
Öbackakliniken
🇸🇪Härnösand, Sweden
Alingsås Hospital
🇸🇪Alingsås, Sweden
Angered Hospital
🇸🇪Angered, Sweden
Halland Hospital Kungsbacka
🇸🇪Kungsbacka, Sweden
Hospital in Motala
🇸🇪Motala, Sweden
Vrinnevi Hospital
🇸🇪Norrköping, Sweden
Södersjukhuset
🇸🇪Stockholm, Sweden
Hospital Trelleborg
🇸🇪Trelleborg, Sweden
Ängelholm Hospital
🇸🇪Ängelholm, Sweden
Academic Hospital Uppsala
🇸🇪Uppsala, Sweden
University Hospital Örebro
🇸🇪Örebro, Sweden
NU Hospital Group
🇸🇪Uddevalla, Sweden
Helsingborg Hospital
🇸🇪Helsingborg, Sweden
Central Hospital Kristianstad
🇸🇪Kristianstad, Sweden
Skåne University Hospital Malmö
🇸🇪Malmö, Sweden