Nurse-based management screening in patients with gestational diabetes

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: Participant are not randomised since the control group is the group of patients before the protocol. The duration of intervention is the pregnancy period and starts at the diagnosis moment and finishes with the delivery. The study does not need randomization since the measure is not taken on two different therapies but on two different organizational protocols P1 and P2, whereas the same therapy was used (the only pharmacological therapy involved was insulin) with the same assessment of blood glucose data. Two different organizational protocols were analysed: The first group of patients was based on a traditional protocol (P1: 230 pts) with patients’ blood glucose constantly checked by a Diabetologist. In the second group P2 was applied (P2: 220 pts), and patients were only referred to a Diabetologist if they required insulin therapy. Organisational Protocol 1 (P1): for this protocol, the Diabetologist manages the entire process even if the patient does not require insulin therapy. Therefore, a nurse and a dietitian, if required, work together under the guidance of a Diabetologist. Organizational Protocol 2 (P2): for this protocol, the Diabetologist intervenes only if the patient requires insulin therapy. Total duration of the study is 2 and a half years. Participants are invited, as described in the protocol, to do a Glucose Tolerance Test (GTT) after 12 weeks after delivery and to show results to their primary care physician. The primary care physician evaluates the need to send the person back to the diabetologist. CONDITION: Gestational diabetes ; Nutritional, Metabolic, Endocrine ; Gestational diabetes PRIMARY OUTCOME: Hypoglycemia is measured using their personal glucose monitor when they feel symptoms, as instructed. SECONDARY OUTCOME: Number of medical visits is measured using patient number of recorded accesses in the Hospital booking system. INCLUSION CRITERIA: 1. Not have type 1 or type 2 diabetes before becoming pregnant 2. Have balanced food habits (50‐60% carbohydrates; 10‐15% protein; 20‐25% fats) based on a Mediterranean‐style diet 3. Have a pre‐pregnancy BMI of between 18 and 35 kg/m2 4. Not having an eating disorder or by any type of prior or current psychiatric illness 5. Not having a heart, kidney or liver disease, thrombophilic diathesis or any other already diagnosed chronic disease (e.g. hereditary dyslipdemia, hypertension resistant to treatment with drugs, gout, etc.) before becoming pregnant 6. Not having pre‐eclampsia during a previous pregnancy 7. Not having a history of recurrent fetal loss 8. Not having cancer (current or previous) 9. Not expecting twins 10. Aged between 18‐45
Epistemonikos ID: 3a6ab9338413d840c456a3c180ebcac885938b2b
First added on: Aug 23, 2024