Monocentric randomised prospective intraindividuel parallel group comparison study to calculate HbA1c of self monitored blood glucose values of the last days and to use blood glucose documentation in a specialized diary with biofeedback system.

Monocentric randomised prospective intraindividuel parallel group comparison study to calculate HbA1c of self monitored blood glucose values of the last days and to use blood glucose documentation in a specialized diary with biofeedback system. - MODESTY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004339

Enrollment

100

Registered

2012-10-09

Start date

2012-09-10

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin dependent diabetes mellitus Insulin dependent diabetes mellitus

Interventions

Group 1: 50 intensified Insulin treated patients measure and documentate blood glucose values in the first three months and measure without documentation in the second three months period. Group 2: 50

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Insulin treated patients with diabetes, who have to measure blood glucose at least four times daily (intensified conventionel therapy). • Insulin treatment at least 6 months. • age over 18 years • signed and dated consent

Exclusion criteria

Exclusion criteria: • reported ketoacidosis in the last 3 months • reported severe hypoglycemic episode in the last 3 months • Pregnancy • patients, who seem unable to follow protokol • hemoglobin 11% • patients, who can not legaly sign consent

Design outcomes

Primary

Measure	Time frame
with hemocue (point of care test) measured HbA1c after 3 and 6 months	—

Secondary

Measure	Time frame
from glucose monitoring system analysed Hypoglycemia, blood glucose variability, calculated HbA1c	—

Countries

Germany

Contacts

Public ContactHans-Eckart Sarnighausen

Praxis

arzt@praxis-oedeme.de+49 4131 2235381

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026