A single-center pilot study to establish a novel hypoglycemic clamp procedure to assess the time to spontaneous recovery from hypoglycemia in people with and without diabetes

Conditions

Type 2 Diabetes Mellitus

Brief summary

Ratio of insulin rates (mU/kg/min) required to lower PG from 90 – 70 mg/dL within 90 min (±30 min) and insulin rates required to lower PG from 70 – 48 mg/dL within 90 min (±30 min)

Detailed description

Comparison of the ratio of insulin rates derived in participants with diabetes versus the ratio of insulin rates derived in participants without diabetes, Comparison of the total insulin amount (mU/kg) required to achieve nadir (PG 48 mg/dL [2.7 mmol/L]) at the first clamp visit versus at the second clamp visit, Comparison of the total insulin amount (mU/kg) required to achieve nadir (PG 48 mg/dL [2.7 mmol/L]) in participants with versus participants without diabetes, Number of participants who achieved spontaneous recovery from hypoglycemia, Number of participants who did not reach nadir (PG 48 mg/dL [2.7 mmol/L]), Number of participants who did not spontaneously recovered after reaching nadir, Time to spontaneous recovery from hypoglycemia, Glucose i.v. (mg/kg) administered within the first 30 minutes after reaching nadir (PG 48 mg/dL [2.7 mmol/L]), Rescue glucose i.v. (mg/kg) administered from 31 – 60 minutes after reaching nadir (PG 48 mg/dL [2.7 mmol/L])

Related papers

No related papers found yet.

Interventions

DRUGNovoRapid 100 units/ml solution for injection in vial

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Ratio of insulin rates (mU/kg/min) required to lower PG from 90 – 70 mg/dL within 90 min (±30 min) and insulin rates required to lower PG from 70 – 48 mg/dL within 90 min (±30 min)	—

Secondary

Measure	Time frame
Comparison of the ratio of insulin rates derived in participants with diabetes versus the ratio of insulin rates derived in participants without diabetes, Comparison of the total insulin amount (mU/kg) required to achieve nadir (PG 48 mg/dL [2.7 mmol/L]) at the first clamp visit versus at the second clamp visit, Comparison of the total insulin amount (mU/kg) required to achieve nadir (PG 48 mg/dL [2.7 mmol/L]) in participants with versus participants without diabetes, Number of participants who achieved spontaneous recovery from hypoglycemia, Number of participants who did not reach nadir (PG 48 mg/dL [2.7 mmol/L]), Number of participants who did not spontaneously recovered after reaching nadir, Time to spontaneous recovery from hypoglycemia, Glucose i.v. (mg/kg) administered within the first 30 minutes after reaching nadir (PG 48 mg/dL [2.7 mmol/L]), Rescue glucose i.v. (mg/kg) administered from 31 – 60 minutes after reaching nadir (PG 48 mg/dL [2.7 mmol/L])	—

Measure

Time frame

Comparison of the ratio of insulin rates derived in participants with diabetes versus the ratio of insulin rates derived in participants without diabetes, Comparison of the total insulin amount (mU/kg) required to achieve nadir (PG 48 mg/dL [2.7 mmol/L]) at the first clamp visit versus at the second clamp visit, Comparison of the total insulin amount (mU/kg) required to achieve nadir (PG 48 mg/dL [2.7 mmol/L]) in participants with versus participants without diabetes, Number of participants who achieved spontaneous recovery from hypoglycemia, Number of participants who did not reach nadir (PG 48 mg/dL [2.7 mmol/L]), Number of participants who did not spontaneously recovered after reaching nadir, Time to spontaneous recovery from hypoglycemia, Glucose i.v. (mg/kg) administered within the first 30 minutes after reaching nadir (PG 48 mg/dL [2.7 mmol/L]), Rescue glucose i.v. (mg/kg) administered from 31 – 60 minutes after reaching nadir (PG 48 mg/dL [2.7 mmol/L])

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Countries

Austria

Outcome results

None listed