Clinical trial NCT02465411: Long Term CGM Treatment in Patients With Type 1 Diabetes Treated With Insulin Injections
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 1
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: DexCom, Inc.
First posted: 2015-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c in venous sample
timeFrame: 52 weeks or 78 weeks
Secondary outcomes:
measure: Mean glucose level measured by CGM during two weeks.
timeFrame: 52 weeks/78 weeks
measure: Mean Amplitude of Glycemic Excursions (MAGE) measured by CGM during two weeks.
timeFrame: 52 weeks/78 weeks
measure: Standard deviation of glucose levels measured by CGM during two weeks.
timeFrame: 52 weeks/78 weeks
measure: Treatment satisfaction: DTSQs scores
timeFrame: 52 weeks/78 weeks
measure: Well being: WHO 5 scores
timeFrame: 52 weeks/78 weeks
measure: Hypoglycemia fear: SWE-HFS scores
timeFrame: 52 weeks/78 weeks
measure: Problem areas: SWE-PAID-20 scores
timeFrame: 52 weeks/78 weeks
measure: Physical activity: IPAQ score
timeFrame: 52 weeks/78 weeks
measure: Treatment experience of CGM score
timeFrame: 52 weeks/78 weeks
measure: Proportion of time with low glucose levels measured by CGM during two weeks.
timeFrame: 52 weeks/78 weeks
measure: Proportion of time with high glucose levels measured by CGM during two weeks.
timeFrame: 52 weeks/78 weeks
measure: Proportion of time with euglycaemic levels measured by CGM during two weeks.
timeFrame: 52 weeks/78 weeks
measure: Proportion of patients lowering their HbA1c by 5 mmol/mol (0.5% in DCCT) or more.
timeFrame: 52 weeks/78 weeks
measure: Proportion of patients lowering their HbA1c 10 mmol/mol (1% in DCCT) or more
timeFrame: 52 weeks/78 weeks
measure: Number of self-reported severe hypoglycaemic events per year
timeFrame: 52 weeks/78 weeks
Other outcomes:
Locations:
city: Alingsås
country: Sweden
facility: Alingsås Hospital
city: Angered
country: Sweden
facility: Angered Hospital
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
city: Härnösand
country: Sweden
facility: Öbackakliniken
city: Kristianstad
country: Sweden
facility: Central Hospital Kristianstad
city: Kungsbacka
country: Sweden
facility: Halland Hospital Kungsbacka
city: Malmö
country: Sweden
facility: Skåne University Hospital Malmö
city: Motala
country: Sweden
facility: Hospital in Motala
city: Norrköping
country: Sweden
facility: Vrinnevi Hospital
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Trelleborg
country: Sweden
facility: Hospital Trelleborg
city: Uddevalla
country: Sweden
facility: NU Hospital Group
city: Uppsala
country: Sweden
facility: Academic Hospital Uppsala
city: Ängelholm
country: Sweden
facility: Ängelholm Hospital
city: Örebro
country: Sweden
facility: University Hospital Örebro
Study officials:
affiliation: NU Hospital Group and University of Gothenburg
name: Marcus Lind, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.