Overview

This trial is active, not recruiting.

Condition diabetes mellitus type 1
Treatment dexcom g4 or later generation
Sponsor Vastra Gotaland Region
Collaborator DexCom, Inc.
Start date June 2015
End date June 2017
Trial size 130 participants
Trial identifier NCT02465411, CGMMDI Extension

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Continuous glucose monitoring with DexCom G4 platina or later generations during 12 months following participation in the CGMMDI trial
dexcom g4 or later generation
Continuous glucose monitoring with DexCom G4 platina or later generations

Primary Outcomes

Measure
HbA1c in venous sample
time frame: 52 weeks or 78 weeks

Secondary Outcomes

Measure
Mean glucose level measured by CGM during two weeks.
time frame: 52 weeks/78 weeks
Mean Amplitude of Glycemic Excursions (MAGE) measured by CGM during two weeks.
time frame: 52 weeks/78 weeks
Standard deviation of glucose levels measured by CGM during two weeks.
time frame: 52 weeks/78 weeks
Treatment satisfaction: DTSQs scores
time frame: 52 weeks/78 weeks
Well being: WHO 5 scores
time frame: 52 weeks/78 weeks
Hypoglycemia fear: SWE-HFS scores
time frame: 52 weeks/78 weeks
Problem areas: SWE-PAID-20 scores
time frame: 52 weeks/78 weeks
Physical activity: IPAQ score
time frame: 52 weeks/78 weeks
Treatment experience of CGM score
time frame: 52 weeks/78 weeks
Proportion of time with low glucose levels measured by CGM during two weeks.
time frame: 52 weeks/78 weeks
Proportion of time with high glucose levels measured by CGM during two weeks.
time frame: 52 weeks/78 weeks
Proportion of time with euglycaemic levels measured by CGM during two weeks.
time frame: 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
Proportion of patients lowering their HbA1c 10 mmol/mol (1% in DCCT) or more
time frame: 52 weeks/78 weeks
Number of self-reported severe hypoglycaemic events per year
time frame: 52 weeks/78 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Marcus Lind, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Vastra Gotaland Region.