Type 1 Diabetes Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
The primary outcome of this study was predefined as a reduction in HbA1c value of more than 0.4% in the experimental group.
Subjects randomised to the experimental group received a Pe
Sponsors
Roche Diagnostics Corporation (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult - male or female, 18 to 60 years of age 2. Diagnosed with Type 1 diabetes mellitus at least six months 3. HbA1c greater than 7.5% and less than 11.0% at screening 4. Insulin dose 0.5 - 2.0 units/kg 5. Hematocrit between 25% and 65% 6. Weight 100 - 300 pounds 7. On a dual insulin therapy supported by Accu-Chek® insulin advisor software 8. On a "day shift" schedule (typical day begins before noon) 9. Willing to perform a minimum of three blood glucose tests per day - before breakfast, before lunch, and before dinner (standard of care) 10. Willing to complete at least 7 clinic visits in 12 months (baseline, 2-week, 6-week, 3-month, 6-month, 9-month, and 12-month) 11. Willing to complete three study phone calls conducted by study coordinator (4.5-month, 7.5-month and 10.5-month) 12. Able and willing to provide written informed consent to participate 13. Willing to comply with the study protocol 14. Willing to be randomised into either the control group or the experimental group
Exclusion criteria
Exclusion criteria: 1. On insulin pump therapy 2. On oral, inhaled or pre-mixed insulin 3. Engaged in a minimum of 30 minutes of cardiovascular (aerobic) exercise 5 days out of a 7-day week 4. Conditions that can cause significant increase of the insulin sensitivity factor, such as a steroid therapy, diabetic ketosis, insulin-resistant syndrome 5. Creatinine greater than 2.5 mg/dl, renal transplantation or currently undergoing kidney dialysis 6. Pregnant or intends to become pregnant during the course of the study 7. Undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer 8. Plan to travel to a different time zone more than three times per month 9. Clinical signs or symptoms of liver disease such as jaundice 10. Diagnosis of acute or chronic hepatitis 11. Diagnosis of haemoglobinopathy or chronic anaemia 12. Severe unexplained hypoglycaemia in the past 3 months that required Emergency Department (ED) admission 13. Participation in another clinical trial in the past 1 month 14. Weight under 100 pounds or over 300 pounds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in glucose control by at least 0.4% reduction in HbA1c values in subjects using insulin guidance software at 6 months and 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes were measured at each of the clinic visits given below for: 1. Hypoglycaemia 2. Weight gain 3. Insulin dose 4. Frequency of self monitoring of blood glucose, within, above and below the target range glycaemia (70 - 150 mg/dL) All subjects were asked to attend seven in-clinic visits (baseline, 2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months) and participate in three telephone visits (4.5 months, 7.5 months, 9.5 months) throughout the course of the study. Data for blood glucose values, testing frequency, hyperglycaemic excursions, hypoglycaemic events (all, nocturnal, and severe), insulin dose, weight and BMI, hospitalisations, emergency room visits and illnesses were recorded at each in clinic visit. All subjects completed a patient satisfaction questionnaire and the experimental group also completed an Advisor questionnaire. As part of their routine clinical care, any additional phone visits were equally encouraged in both groups. | — |
Countries
United States of America
Outcome results
None listed