Trial Outcomes & Findings for Effects of Mild Hypoglycaemia on Cognitive Function in Type 2 Diabetes (NCT NCT03014011)

NCT ID: NCT03014011

Last Updated: 2020-01-28

Results Overview

Symbol Digit Modalities Test was used as a measurement of psychomotor speed. For the Symbol Digit Modalities Test, participants were required to use a coded key to match nine abstract symbols paired with numerical digits. The final score is the correct number of substitutions in 120 s, and scores range between 0 and 110. Higher values represent a better outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: All neurocognitive testing was assessed at each intervention when glucose levels had been stabile for 40 minutes, an average of 2 hours after clamp procedure start. The duration of neurocognitive testing was approximately 40 min.
• Results posted on: 2020-01-28

Participant Flow

37 participants were screened between May 2017 and July 2018 at the Department of Endocrinology, Bispebjerg University Hospital, Denmark.

Of the 37 screened participants, 28 met inclusion criteria and were randomised. 25 completed both intervention visits. Three participants (one man, two women) withdrew from the study after randomisation for reasons not related to the intervention. Baseline characteristics are based on the 25 participants that completed the study.

Participant milestones

Measure	Hypoglycaemic Clamp Followed by Euglycaemic Clamp Participants completed a hypoglycaemic clamp on a first intervention visit. After a washout period of at least 2 weeks (maximum of 6 weeks), a euglycaemic clamp was performed on the second intervention visit.	Euglycaemic Clamp Followed by Hypoglycaemic Clamp Participants completed a euglycaemic clamp on a first intervention visit. After a washout periodof at least 2 weeks (maximum of 6 weeks), a hypoglycaemic clamp was performed on the second intervention visit.
First Intervention STARTED	14	13
First Intervention COMPLETED	13	13
First Intervention NOT COMPLETED	1	0
Washout STARTED	13	13
Washout COMPLETED	12	13
Washout NOT COMPLETED	1	0
Second Intervention STARTED	12	13
Second Intervention COMPLETED	12	13
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Hypoglycaemic Clamp Followed by Euglycaemic Clamp Participants completed a hypoglycaemic clamp on a first intervention visit. After a washout period of at least 2 weeks (maximum of 6 weeks), a euglycaemic clamp was performed on the second intervention visit.	Euglycaemic Clamp Followed by Hypoglycaemic Clamp Participants completed a euglycaemic clamp on a first intervention visit. After a washout periodof at least 2 weeks (maximum of 6 weeks), a hypoglycaemic clamp was performed on the second intervention visit.
First Intervention Withdrawal by Subject	1	0
Washout Withdrawal by Subject	1	0

Baseline Characteristics

Effects of Mild Hypoglycaemia on Cognitive Function in Type 2 Diabetes

Baseline characteristics by cohort

Measure	All Participants n=25 Participants Randomised, double-blinded, crossover study design
Age, Continuous	60.2 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Denmark	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: All neurocognitive testing was assessed at each intervention when glucose levels had been stabile for 40 minutes, an average of 2 hours after clamp procedure start. The duration of neurocognitive testing was approximately 40 min.

Population: The two interventions were hypoglycaemia (aiming for a plasma glucose target of 3.0 ± 0.2 mmol/l) and euglycaemia (plasma glucose clamp target 6.0 ± 0.2 mmol/l).

Symbol Digit Modalities Test was used as a measurement of psychomotor speed.

For the Symbol Digit Modalities Test, participants were required to use a coded key to match nine abstract symbols paired with numerical digits. The final score is the correct number of substitutions in 120 s, and scores range between 0 and 110. Higher values represent a better outcome.

Outcome measures

Measure	Hypoglycaemia n=25 Participants low glucose level	Euglycaemia n=25 Participants normal glucose level
Psychomotor Speed	48.7 score on a scale Standard Deviation 9.8	56.6 score on a scale Standard Deviation 12

Adverse Events

Hypoglycaemic Clamp

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Euglycaemic Clamp

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

MD Malin Nilsson

Bispebjerg Hospital

Phone: 50595861

Email: mnil0028@regionh.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place