A structured approach to home glucose monitoring for type 2 diabetes patients using insulin

The effect of a structured self-monitoring blood glucose regimen on glycaemic control for type 2 diabetes patients using insulin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13215752

Enrollment

Registered

2017-01-16

Start date

2015-01-26

Completion date

Unknown

Last updated

2017-02-20

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

Conditions

Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

Participants are asked to perform four blood glucose tests for three consecutive days of each week. On each of the self-monitoring of blood glucose (SMBG) days, a fasting breakfast and bed-time glucos

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Duration of type 2 diabetes >1 year 2. Aged 18 to 75 years 3. HbA1c = 8.5% (69.4 mmol/mol) 4. Currently treated with = 1 insulin injection per day 5. Voluntarily signing the informed consent document

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes 2. Participation in any other research protocol within the last 30 days 3. Current use of oral hypoglycaemic agents other than Metformin 4. History of cancer within the last five years 5. Currently treated with chemotherapy or radiation therapy 6. Plans to relocate or travel extensively during the following six months 7. Pregnant or breast feeding 8. One or more severe hypoglycaemic episode(s) within the previous six months that resulted in hospital admission and/or coma 9. Severe depression or other severe psychological conditions 10. History of chronic kidney disease 11. History of heart failure where cardiovascular status is unstable 12. Manual or visual disability that required dependency on others to give insulin or to document blood glucose values 13. Major surgery scheduled within six months of enrolment 14. Current use of oral corticosteroids

Design outcomes

Primary

Measure	Time frame
Glycated hemoglobin (HbA1c) is measured using the Cobus B101 (Roche Products, South Africa) at baseline, 3 and 6 months.	—

Secondary

Measure	Time frame
1. Total daily insulin dose is measured by recording number of international units of insulin per day at baseline, 1, 2, 3, 4, 5 and 6 months 2. Glycaemic variability is measured using standard deviation of SMBG data at baseline, 1, 2, 3, 4, 5 and 6 months" 3. Mean fasting plasma glucose (FPG) is measured using by calculating the mean of SMBG tests performed before breakfast for each month at baseline, 1, 2, 3, 4, 5 and 6 months 4. Mean post-prandial glucose (PPG) values is measured by calculating the difference in 12 paired pre- and post-meal blood glucose values for each month at baseline, 1, 2, 3, 4, 5 and 6 months 5. Overall efficacy is measured by recording the proportion of patients reaching an HbA1c target <7.0% (53 mmol/mol) at 6 months 6. Hypoglycaemic event rate is calculated as [(total number of SMBG <4.0mmol/L across all participants) / (total duration of treatment in years across all participants)] at 6 months 7. Weight is measured using a digital scale at baseline, 1, 2, 3, 4, 5 and 6 months 8. Compliance to SMBG protocol is measured by recording the total number of SMBG tests performed out of a maximum of 288 throughout the study period at 6 months	—

Measure

Time frame

1. Total daily insulin dose is measured by recording number of international units of insulin per day at baseline, 1, 2, 3, 4, 5 and 6 months 2. Glycaemic variability is measured using standard deviation of SMBG data at baseline, 1, 2, 3, 4, 5 and 6 months" 3. Mean fasting plasma glucose (FPG) is measured using by calculating the mean of SMBG tests performed before breakfast for each month at baseline, 1, 2, 3, 4, 5 and 6 months 4. Mean post-prandial glucose (PPG) values is measured by calculating the difference in 12 paired pre- and post-meal blood glucose values for each month at baseline, 1, 2, 3, 4, 5 and 6 months 5. Overall efficacy is measured by recording the proportion of patients reaching an HbA1c target <7.0% (53 mmol/mol) at 6 months 6. Hypoglycaemic event rate is calculated as [(total number of SMBG <4.0mmol/L across all participants) / (total duration of treatment in years across all participants)] at 6 months 7. Weight is measured using a digital scale at baseline, 1, 2, 3, 4, 5 and 6 months 8. Compliance to SMBG protocol is measured by recording the total number of SMBG tests performed out of a maximum of 288 throughout the study period at 6 months

—

Countries

South Africa

Contacts

Public ContactKerry Kalweit

k.kalweit@live.com+27832778260

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026