this research answers the need to evaluate whether the 780G hybrid closed-loop system in pregnant women with T1DM can improve glycaemic control with less hypoglycaemia. This in turn, might improve pregnancy outcomes in women with T1DM.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
time in range (glucose 3.5-7.8 mmol/l)
Secondary outcome
* Number and duration of hypoglycaemic episodes (time glucose <3.5 mmol/l, time
<2.8 mmol/l).
* Glucose variability, mean glucose level and percentages of time in target
overnight, during the day and evening.
* Total insulin dose.
* Continuous glucose monitoring compliance.
* Treatment satisfaction.
* Pregnancy outcomes.
* The cost-effectiveness of the closed-loop system compared to standard of
care.
Background summary
Type 1 diabetes during pregnancy leads to a higher risk of several
complications for mother as well as the child (such as preterm birth, caesarian
section, pre-eclampsia). The most important goal of the antenatal care is to
obtain well regulated glucose levels, because that is associated with better
pregnancy outcomes. However, strict glucose regulation during pregnancy is
difficult to obtain. The purpose of the current study is to assess whether a
closed loop systen combined with a glucose sensor (the 780G MiniMed
insulinpump, Medtronic bv) leads to better glucose control without increase of
hypoglycemic events in pregnant women with type 1 diabetes. Earlier research
showed that use of continuous glucose monitoring leads to better pregnancy
outcomes, but whether a closed loop system further improves outcomes is not
known. This closed loop system was given a CE-mark in Europe from May 2020 for
the use in patients with diabetes mellitus type 1. It's use in pregnant women
has not been approved yet.
Study objective
this research answers the need to evaluate whether the 780G hybrid closed-loop
system in pregnant women with T1DM can improve glycaemic control with less
hypoglycaemia. This in turn, might improve pregnancy outcomes in women with
T1DM.
Study design
randomised, open-label, study
Intervention
intervention arm: treatment with the 780G MiniMed insulin pump combined with
continuous glucose monitoring
control arm: standard care
Study burden and risks
- at a maximum of 6 moments in pregnancy, extra blood will be taken for the
purpose of the study (maximum 24ml per drawing) and will be asked to fill in
questionnaires. Filling in the questionnaires will take 20-30 minutes and will
be plannend during a regular visit at the diabetes clinic. (Participants do not
have to come to the hospital only for study purpose.)
- participants in the intervention arm change their diabetes treatment. Before
starting the intervention treatment, they will be educated which will take
approximately 4 hours. As can occur with the use of any insulin pump, technical
problems are possible that can lead to malfunction of the insulin supply from
the 780 pump (such as when the catheter is blocked). This can rarely lead to
diabetic keto-acidosis (DKA). The 780G system has built-in safety systems that
alert to such problems and indicate how the problem can be solved. It will
always be ensured that an alternative emergency treatment with insulin
injections is available in the rare case that the technical problems cannot be
solved immediately. Also the technical helpdesk of the manufacturer will be
available 24/7.
- The participants in the control arm will be asked to wear a blinded glucose
monitor during 21 days for a maximum of 5 times during pregnancy. This is
necessary to be able to evaluate the glucose levels between the intervention
and control arm in a standardized way. During the wear of the blinded sensor,
it is necessary to measure blood glucose by fingerprick two times a day for
calibration. If a participant already uses a CGM of Medtronic, no blind sensor
wear is necessary because then the same CGM as the intervention arm is already
in use. Performing a finger prick for glucose measurement can be somewhat
painful, however contains no risk.
the current study can only be carried out in this specific population.
Potentially the participant benefits from the intervention through improvement
of glucose values and quality of life. The 780G closed loop system is already
used by patients with diabetes mellitus type 1 with great satisfaction and
improvement of glucose values and quality of life in the majority of users.
Herestraat 49
Leuven B - 3000
BE
Herestraat 49
Leuven B - 3000
BE
Listed location countries
Inclusion criteria
• Women with T1DM, diagnosed at least 1 year before pregnancy
• Age 18-45 years
• A singleton pregnancy confirmed by b-HCG in blood and/or ultrasound-confirmed
gestational age up to 11 weeks and 6 days.
• Treated with intensive insulin treatment (either MDI, insulin pump). A
closed-loop system can only be used in manual mode.
• HbA1c level <=10%.
• Participants need to speak and understand Dutch or English and have e-mail
access.
Exclusion criteria
• The use of a closed-loop insulin delivery system in auto mode.
• A twin (multiple) pregnancy
• A physical or psychological disease likely to interfere with the conduct of
the study (based on the evaluation by the treating physician)
• Medications known to interfere with glucose metabolism
• A daily insulin dose of >=1.5 units/kg
• Known allergy to adhesives due to infusion set and/or continuous glucose
monitor
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04520971 |
| CCMO | NL78535.000.21 |